Ennis & Ennis, P.A. Blog

FDA Approves New Byetta Label Amid Renal-Failure Reports

J Murawski — 2009-11-05T04:14:00Z

For more information about Byetta Side Effects or Byetta Lawsuit Information please visit: http://www.ennislaw.com/byetta.html

-Wall Street Journal

11/04/2009 - The U.S. Food and Drug Administration on Monday said it approved a new label for the diabetes treatment Byetta, made by Eli Lilly & Co. (LLY) and Amylin Pharmaceuticals Inc. (AMLN), amid reports the medicine may cause kidney problems.

From April 2005 through October 2008, the FDA has received 78 reports of patients taking Byetta who have had altered kidney function, including renal failure, according to an alert the agency sent to doctors on Monday. The alert was posted to the FDA's Web site.

The agency said it received 62 cases of acute renal failure and 16 cases of renal insufficiency in patients taking the medicine, which on Friday received FDA approval to be used as a stand-alone treatment for controlling sugar levels in patients with Type 2 diabetes. Previously, the drug had been approved only in patients who were also on other diabetes medications.

The FDA told doctors that some of the reports of kidney malfunction were in patients who had pre-existing kidney disease or with one or more risk factors for developing kidney problems.

From April 2005 through September 2008, more than 6.6 million prescriptions for Byetta were dispensed, the FDA said. "Therefore, the 78 reported cases of altered renal function represent a small percentage of the total number of patients who have used the drug," the agency said.

The FDA said the new label will include details of the reports of altered kidney function to allow doctors to "better weigh the known benefits of Byetta with the potential risks that exist for certain patients."

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Antipsychotic Drugs Can Cause Rapid Weight Gain in Kids

J Murawski — 2009-11-05T04:01:00Z

For more information about Seroquel Side Effects or Seroquel Lawsuit Information visit http://www.ennislaw.com/seroquel_form.html

-FNA

11/04/2009 - Results of a new study suggested that prescription of antipsychotic drugs for children could be a factor in their rapid weight gain and may raise the risk for diabetes and heart disease.

The study showed that up to one-third of adolescents and children who took some of the common antipsychotic drugs for the first time became overweight or obese in as little as 11 weeks, which in turn raised their risk for diabetes and heart disease.

Researchers said that doctors who prescribe these antipsychotics to children should carefully consider the benefits against the risk, and keep a close eye on the children who are taking these medications.

"These data confirm prior findings that children and adolescents are highly vulnerable to antipsychotic medication. These results challenge the widespread use of atypical antipsychotic medications in youth," Dr. Christopher Varley and Dr. Jon McClellan from the Seattle Children's Hospital wrote in a commentary for the Journal of the American Medical Association.

Dr. Monica Michell, a child psychiatrist at the Lenox Hill Hospital in New York who was not involved with this study, said that these findings caution us and underscores the long-term potential harm that these drugs can cause.

"For children, who are not psychotic or bipolar, these medicines should be a last resort," she stated.

This study looked at four of the most common antipsychotic medications used in children: Risperdal or risperidone made by Johnson & Johnson, Zyprexa or olanzapine made by Eli Lilly, Abilify or aripiprazole made by Bristol-Myers Squibb, and Seroquel or quetiapine made by AstraZeneca.

A research team, led by Dr. Christopher Correll from Zucker Hillside Hospital and the Feinstein Institute for Medical Research in New York, studied approximately 272 teens and children who were between the ages of 4 to 19 that suffered from schizophrenia, bipolar disorder, and aggressive or disruptive behavior spectrum disorders.

After approximately 11 weeks, the participants that took Zyprexa gained an average of 18.7 pounds, those who took Seroquel gained 13.4 pounds, those who took Risperdal gained 11.7 pounds and those who took Abilify gained 9.7 pounds. Altogether, 10 to 36 percent of participants became overweight or obese within 11 weeks.

"The weight gain is dramatic, rapid and pervasive," Correll stated. However, he said, not all of the medications performed the same.

The children who took Zyprexa showed to have the most dramatic weight gain and the biggest changes in their metabolic factors such as cholesterol, triglycerides and blood sugar, which can cause diabetes and heart problems.

Abilify, a medication that is usually not linked with weight gain in adults, did cause the kids to gain weight but was not shown to raise blood sugar levels or cholesterol.

Correll hopes to be able to conduct more research to help determine what caused these differences.

"We will look at genetics and look at blood samples to see what changed early on that predicted weight gain," he said.

Currently, only two atypical antipsychotics are approved for children to take, Abilify and Risperdal. However, in June, a Food and Drug Administration panel of experts backed the wider use of Seroquel, Zyprexa, and Pfizer's Geodon for teens and children.

At the time, many of the panel members expressed their concerns about the rising sales of the drugs to young people and the lack of long-term studies for safety.

The members were especially worried about the chance that the drugs might be misused to treat other conditions such as attention deficit hyperactivity disorder. The FDA has still not acted on the panel's endorsement.

Last November, a panel of outside experts called on the FDA and other US healthy agencies to help study the long-term effects of prescribing these antipsychotic medications to kids.

-FNA

11/04/2009 - Results of a new study suggested that prescription of antipsychotic drugs for children could be a factor in their rapid weight gain and may raise the risk for diabetes and heart disease.

"For children, who are not psychotic or bipolar, these medicines should be a last resort," she stated.

"The weight gain is dramatic, rapid and pervasive," Correll stated. However, he said, not all of the medications performed the same.

Abilify, a medication that is usually not linked with weight gain in adults, did cause the kids to gain weight but was not shown to raise blood sugar levels or cholesterol.

Correll hopes to be able to conduct more research to help determine what caused these differences.

"We will look at genetics and look at blood samples to see what changed early on that predicted weight gain," he said.

At the time, many of the panel members expressed their concerns about the rising sales of the drugs to young people and the lack of long-term studies for safety.

Last November, a panel of outside experts called on the FDA and other US healthy agencies to help study the long-term effects of prescribing these antipsychotic medications to kids.

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Owners of Toyota Cars in Rebellion Over Series of Accidents Caused by Sudden Acceleration

J Murawski — 2009-11-05T03:56:00Z

For more information about the Toyota/Lexus floor mat recall or lawsuit information visit
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ABC News Investigation Uncovers Reports of 16 Deaths, Over 200 Accidents; Toyota Owners Demand Answers

-ABC NEWS

11/04/2009 - Refusing to accept the explanation of Toyota and the federal government, hundreds of Toyota owners are in rebellion after a series of accidents caused by what they call "runaway cars."

Safety analysts found an estimated 2000 cases in which owners of Toyota cars including Camry, Prius and Lexus, reported that their cars surged without warning up to speeds of 100 miles per hour.

Toyota says the incidents are caused by floor mats becoming stuck under gas pedals, but owners say that's not what happened to them.

"I'm absolutely certain that in my situation, it was not the floor mats," Elizabeth James told ABC News. She was driving her Toyota Prius outside Denver, CO when she says it suddenly shot up to 90 miles an hour, even though her foot was on the brake and not the gas pedal.

"I kept going faster and faster," James said. "And all of a sudden… my foot was pressing on the brake super, super hard and I wasn't slowing down."

James and some other Toyota owners suspect the accidents have been caused by some kind of glitch in the electronic computer system used in Toyotas that controls the throttle.

Toyota officials refused to talk with ABC News about the incidents, but posted a statement from executive Bob Daly on its website last night that said: "Some news reports suggest there may be other causes of unintended acceleration, speculating about electronic engine control systems, braking performance or electro-magnetic interference among other theories. There is no evidence to support these theories."

The National Highway Traffic Safety Administration has done six separate investigations of such acceleration surges in Toyotas since 2003 and found no defect in Toyota's electronics.

The U.S. Department of Transportation released a statement Tuesday afternoon saying the matter "is not closed."

The full statement read: " Toyota has announced a safety recall involving 3.8 million vehicles in which the accelerator pedal may become stuck at high vehicle speeds due to interference by the driver's side floor mat, which is obviously a very dangerous situation. Toyota has written to vehicle owners stating that it has decided that a safety defect exists in their vehicles and asking owners to remove all floor mats while the company is developing a remedy. We believe consumers should follow Toyota's recommendation to address the most immediate safety risk. However, removal of the mats is simply an interim measure, not a remedy of the underlying defect in the vehicles. NHTSA is discussing with Toyota what the appropriate vehicle remedy or remedies will be. This matter is not closed until Toyota has effectively addressed the vehicle defect by providing a suitable remedy."

Some Toyota Owners Point to Problem Other than Floor Mats

Many Toyota owners remain convinced that an electronic problem is to blame.

Bulent Ezal was driving with his wife of 46 years in their Toyota Camry in central California, when he says it suddenly took off. The car plunged over a 100 foot cliff into the Pacific ocean, and while he survived, his wife did not.

"All of a sudden the car surged with force and I was thrown back to the seat," Ezal said. The last thing he heard was his wife screaming before he blacked out. Toyota says the accident was caused by Ezal mistakenly pushing the gas pedal, but Ezal is adamant that his foot was "absolutely, positively on the brake."

There have been other deaths as well, including a fatal accident near San Diego this August that took the lives of California Highway patrol officer Mark Saylor, his wife, daughter and brother-in-law.

The Lexus they were driving, borrowed from a dealer, raced out of control at 100 miles an hour before hitting another vehicle, crashing into an embankment and bursting into flames.

Right before the crash, Saylor's brother-in-law called 911 from the backseat of the vehicle and said urgently, "Our accelerator is stuck. We're in trouble…There's no brakes."

Toyota said the problem was the wrong-sized, all-weather rubber floor mat in the car which was caught and held down the gas pedal. The company ordered a huge floor mat recall for 3.8 million cars.

In Tokyo, the president of Toyota, Akio Toyoda, formally apologized, saying, "Four precious lives have been lost. I offer my deepest condolences."

But many Toyota owners remained unconvinced, including Elizabeth James in Denver, CO and her husband Ted. They organized a YouTube campaign accusing Toyota of gross negligence and cover-up and are demanding answers.

For more information about the Toyota/Lexus floor mat recall or lawsuit information visit http://www.ennislaw.com/toyota_floor_mat_recall.html

FDA: Byetta Label Revised to Include Safety Information on Possible Kidney Problems

J Murawski — 2009-11-03T02:39:00Z

For more information about Byetta Side Effects or Byetta Lawsuit Information please visit: http://www.ennislaw.com/byetta.html

-FDA

11/02/2009 - The U.S. Food and Drug Administration today acted on new safety information about possible kidney function problems, including kidney failure, in patients taking Byetta (exenatide), a drug used to treat Type 2 diabetes.

From April 2005 through October 2008, the FDA received 78 reports of problems with kidney function in patients using Byetta. Some cases occurred in patients with pre-existing kidney disease or in patients with one or more risk factors for developing kidney problems.

Nearly 7 million prescriptions for Byetta were dispensed between April 2005 and September 2008. The 78 cases represent a small percentage of the total number of patients using the drug to control blood sugar (glucose) levels.

The most common side effects associated with Byetta include nausea, vomiting, and diarrhea. These side effects may have contributed to the development of altered kidney function. Kidney malfunction can result in a build-up of waste products in the blood, leading to serious illness or life-threatening conditions.

“Health care professionals and patients taking Byetta should pay close attention to any signs or symptoms of kidney problems,” said Amy Egan, M.D. M.P.H., of the Division of Metabolism and Endocrinology Products at the FDA’s Center for Drug Evaluation and Research. “Patients also should be aware that problems with kidney function could lead to changes in urine color, frequency of urination or the amount of urine, unexplained swelling of the hands or feet, fatigue, changes in appetite or digestion, or dull ache in mid to lower back.”

Patients who experience any of these symptoms should immediately discuss them with their health care professional.

To help health care professionals and patients better weigh the known risks and benefits of Byetta, the FDA worked with the manufacturer to update the drug’s prescribing information (label). A description of these label changes can be found online.

Byetta is manufactured by San Diego-based Amylin Pharmaceuticals Inc.

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Accutane (Isotretinoin) Use Linked to Increased Risk of IBD: Presented at ACG

J Murawski — 2009-11-02T02:15:00Z

For more information about Accutane Side Effects or Accutane Lawsuit information visit: http://www.ennislaw.com/accutane.html

-DoctorsGuide

11/01/2009 - Results from a retrospective study presented here at the American College of Gastroenterology (ACG) 74th Annual Scientific Meeting suggest that use of isotretinoin is associated with the development of inflammatory bowel disease (IBD).

"We performed a case control study looking at the connection between [isotretinoin] and inflammatory bowel disease," said lead investigator Seth Crockett, MD, University of North Carolina Medical School at Chapel Hill, Chapel Hill, North Carolina, on October 27.

"We found that there did appear to be an association between prior [isotretinoin] use and subsequent development of ulcerative colitis. There appeared to be approximately a 4 times increased risk for those who had taken [isotretinoin] compared with those who had not."

The researchers extracted data from a claims database containing information on 55 million patients from over 70 health plans in the United States (PharMetrics, IMS Health, Watertown, MA).

From those with at least 12 months of continuous health plan enrolment, they identified cases of Crohn's disease, ulcerative colitis, and indeterminate IBD. They matched each case (n = 8,189; 56% female) to 3 non-IBD controls (n = 21,832; 56% female) on the basis of age, gender, and geographical region.

They evaluated case records for isotretinoin exposure in the 12 months prior to the first IBD diagnosis, or in the first 12 months of enrolment for controls. They used standard statistical analysis to compare cases with controls.

Case records showed that 3,664 (45%) had Crohn's disease, 4,428 (54%) had ulcerative colitis, and 97 (1%) had indeterminate IBD.

The researchers identified prior isotretinoin use in the records of 60 subjects (24 cases and 36 controls).

They reported that the unadjusted odds ratio (OR) of IBD for isotretinoin use was 1.78 (95% confidence interval [CI], 1.02-3.07). After adjusting for potential confounding variables (age, sex, geographic region), the OR decreased slightly to 1.68 (95% CI, 0.98-2.86).

Dr. Crockett noted that an increase in per-patient prescriptions of isotretinoin was associated with an increasing IBD risk. Four or more prescriptions associated with an OR of 2.67 (95% CI, 1.32-5.41).

He also reported that ulcerative colitis was strongly associated with prior isotretinoin use (OR = 4.36; 95% CI, 1.97-9.66), and that the analysis showed no association between isotretinoin use and Crohn's disease (OR = 0.68; 95% CI, 0.28-1.68).

Dr. Crockett and colleagues concluded that more studies are needed to confirm their findings in other populations, and to describe, on a biological level, the relationship between isotretinoin and the risk of IBD.

Funding for this study was provided by the US National Institutes of Health.

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Hylla to hear motions in Accutane suit

J Murawski — 2009-11-02T02:07:00Z

For more information about Accutane Side Effects, or Accutane Lawsuit Information please visit
http://www.ennislaw.com or http://www.the-accutane-lawyer.com

-The St.Clair Record

11/01/2009 - It's been over a month since Madison County Circuit Judge David Hylla heard arguments in a case over the acne drug Accutane and, with the case's Oct. 19 trial date past, he is scheduled to hear more motions in the suit on Nov. 3.

On the table is a move to bar an unpublished university study on the drug's effects on the digestive tract and other discovery matters.

The case's trial has been postponed several times. Had it gone to trial on its original 2007 date, the case would have been the first Accutane trial in the United States.

The case was last scheduled to open for a jury Oct. 19.

Plaintiff Jason Peipert is suing his dermatologist, Dr. Daniel Goran and the makers of Accutane, Hoffman-La Roche Inc. and Roche laboratories. He claims that Goran negligently prescribed the drug in 1999 knowing that its effects are difficult to manage in patients.

Peipert claims he developed a bowel disease as a result of taking the drug.

Accutane was taken off the U.S. market by its makers in June.

Peipert's suit seeks damages of at least $50,000 in damages and costs.

In the last motion hearing in the suit, Hylla granted a defense motion to bar certain testimony. That hearing was held Sept. 24.

Since that hearing, the defendants have asked Hylla to bar the use of an unpublished study on Accutane conducted by the University of North Carolina.

The plaintiff has filed several discovery notices including notices of witnesses and depositions.

The Nov. 3 hearing is set for 10 a.m.

Peipert is represented by John Papa.

The defendants are represented by Bart Sullivan and William Gage.

The case is Madison case number 03-L-2040.

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Ennis & Ennis, P.A. is Still Accepting Accutane Cases against Hoffman La-Roche

J Murawski — 2009-10-28T02:02:00Z

For more information about Accutane Side Effects or Accutane Lawsuit information visit: http://www.ennislaw.com/accutane.html

OpenPress

10/27/2009 - Ennis & Ennis, P.A. announces today it is still investigating and accepting Accutane cases against the manufacturer of the drug Hoffman La-Roche. David Ennis states, "although Hoffman La-Roche announced in June 2009 that it will no longer sell Accutane due to generic competition and large legal costs defending the drug this does not absolve La-Roche from liability from patients who took the drug in the past and have suffered Inflammatory Bowel Disease (IBD), Ulcerative Colitis and Crohn’s Disease". Ennis went on to state 6 juries in New Jersey have ruled in favor of plaintiffs in excess of $33,000,000 in damages finding that the company did not adequately warn of the side effects associated with IBD, Ulcerative Colitis and Crohn's Disease. Ennis believes that there are thousands of patients who suffered from these side effects and are not aware it was due to Accutane use.

Ennis & Ennis, P.A. is also investigating and accepting cases against the generic manufacturers of Isotretinoin which is the generic name for Accutane. The generic versions of the drug are Sotret, Claravis and Amnesteem. Ennis states, "The generic drug makers have the same duty to warn as La-Roche, but they have chosen to use the same label as La-Roche which is a head in the sand approach. It is amazing to me that based on the court findings and evidence presented at trial which is now in the public domain the FDA has not stepped in to require a Black Box warning."

Ennis & Ennis, P.A. has been accepting and investigating Accutane cases since 2003. Ennis & Ennis, P.A. continues to offer free legal consultations to all users of Accutane and Isotretinoin that may have developed IBD, Ulcerative Colitis or Crohn’s Disease. Potential victims can call toll-free 1-800-856-6405 or go to http://www.ennislaw.com or http://www.the-accutane-lawyer.com and fill out a free online case evaluation form.

Ennis & Ennis, P.A. is a nationwide law firm with offices in Ft. Lauderdale, Miami and Washington D.C. Ennis & Ennis, P.A. specializes in mass torts and represents individuals against pharmaceutical companies worldwide as well as medical device makers.

Diabetes drugs may leave heart at greater risk

J Murawski — 2009-10-25T01:14:00Z

For more information about Avandia Side Effects or Avandia Lawsuit Information visit: http://www.ennislaw.com/avandia_lawyer.html

-LA Times

10/24/2009 - Medications for Type 2 (adult-onset) diabetes are very effective at controlling blood sugar levels. You'd think, then, that the drugs would also be very effective at controlling complications of the disease related to those spikes in blood sugar: cardiovascular disease, kidney failure, blindness, nerve damage and amputation of limbs. Surprisingly, though, that has not turned out to be the case for cardiovascular events such as heart attacks and strokes. One study, in fact, hints that too-tight control may even cause patients harm.

Because of these findings, some doctors are beginning to argue that more is not always better with glucose control, particularly when weighed against the downsides of intensive drug treatment, such as hypoglycemic episodes (potentially dangerous dips in blood sugar levels) and weight gain.

Here's a closer look at how treating diabetes with medications affects the risk of cardiovascular disease, one of the most difficult and common complications of diabetes.

Patients with Type 2 diabetes have rates of heart disease two to four times the normal rate, and some two-thirds of them die from a heart disease-related event. Researchers have studied how well the anti-diabetes drugs protect against this worst-case scenario.

The first real tipoff that the heart might not be protected by these medications came from a 10-year British study of 3,867 men and women with diabetes that was published in the Lancet in 1998. It compared treatment with oral medications (sulfonylurea or metformin) or insulin with a more conventional treatment for that time: dietary control supplemented with drugs if blood glucose climbed higher than 270 mg/dL.

The more intensive treatments helped patients keep their blood sugar in check and reduced the risk of side effects on the eyes, kidneys and nerves. Protection against heart disease, however, was not statistically significant.

These findings spurred more research, and in June 2008 results from two much larger U.S. studies were published in the New England Journal of Medicine.

One of them, which had been discontinued after three years because of safety concerns, treated 10,251 patients with diabetes in one of two ways. One group got standard treatment (with oral drugs such as metformin, glimepiride, thiazolidinedione and often insulin) to get blood glucose levels down to an average of 155 mg/dL to 180 mg/dL over a period of three months. The other got intensive treatment to achieve even lower blood glucose levels, below 125 mg/dL.

The trial was stopped when researchers found that there were more deaths from any cause and more cardiovascular-related deaths in the intensive treatment group than in the standard treatment group.

This discouraging result suggests that working harder to lower blood glucose in Type 2 diabetes not only doesn't reduce risk for heart disease, but may in fact bring harm.

The other study, of 11,140 diabetic men and women who were followed for five years, also tested intensive therapy against standard therapy and found neither benefit nor harm with regard to cardiovascular disease or death.

Parsing the risks and benefits in diabetes treatment is complicated by the fact that patients with diabetes receive a broad variety of drugs to help control blood sugar: In addition to metformin (Glucophage) and sulfonylureas, such as Diabinese and Glucotrol, there are the meglitinides, such as Prandin and Starlix, the thiazolidinediones, such as Avandia and Actos, alpha-glucosidase inhibitors such as Precose and Glyset, and the dipeptidyl peptidase-4 inhibitor Januvia (sitagliptin). The possibility remains that these drugs differ in how well they protect against long-term complications of the disease. But studies to test this have not been done.

"The majority of patients start with metformin," says Steven Chen, a USC pharmacist who runs a diabetes management program. Often, patients need a second drug to achieve glucose control; Chen says sulfonylureas typically come next. "Once you get to that point -- a maximum dose of metformin and sulfonylurea -- now you have this whole laundry list of drugs you can choose from. But what you don't have are clinical trials showing long-term safety and efficacy."

Dr. William Duckworth, who directs diabetes research at the Carl T. Hayden VA Medical Center in Phoenix, says that heart disease goes hand-in-hand with diabetes. He doesn't think that the drugs are raising the risk, as one of the two large studies found -- just that they're not very good at lowering it.

Duckworth was co-author of a study of diabetes treatment and cardiovascular disease in 1,791 veterans, which -- like the others -- showed no significant cardiovascular benefit. However, when he did a reanalysis of his data, he found a reduced risk of cardiovascular disease in more recently diagnosed patients who underwent intensive treatment. That leads him to believe that "glucose control is effective if you do it early in the disease," he says.

But this reanalysis (which was presented at a diabetes meeting in June) still needs confirmation, says Dr. Victor Montori, a physician-researcher at the Mayo Clinic in Rochester, Minn. For his part, he thinks that tight glucose control may be getting far too much emphasis in the management of diabetes.

In an April paper in the Annals of Internal Medicine, he pointed to the dearth of benefits of tight glucose control in studies and advocated "good enough" glucose control instead. What this means would depend on the individual patient, Montori says, but would include weighing the benefits of sugar control against some of the undesirable effects of diabetes medications. Many of the drugs cause patients to gain weight, and they can often trigger hypoglycemia, a dip in blood sugar (to less than 70 mg/dL) that's accompanied by shaking, dizziness and sudden sweating.

Montori notes that a good-enough blood sugar strategy would also ease the sheer time and energy it takes to manage diabetes. Treatment regimens -- with frequent doses of pills or insulin, blood-sugar monitoring and doctor visits -- are complicated and burdensome, particularly in patients who may be elderly and have other chronic conditions, such as high blood pressure and high cholesterol. One estimate of the time patients spend taking care of their condition, if they follow all the advice of their doctors, is 143 minutes per day. "That's as much as a part-time job," Montori says.

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Confusing Choices for Doctors and Type 2 Diabetes Patients

J Murawski — 2009-10-24T00:34:00Z

For more information about Avandia Side Effects or Avandia Lawsuit Information visit: http://www.ennislaw.com/avandia_lawyer.html

-GEN

10/23/2009 - Given the current worldwide type 2 diabetes epidemic, it’s hard for drug developers to ignore the huge potential for new, better, and safer oral drugs. The U.S. market alone has reached $5 billion annually, and the prevalence of type 2 diabetes continues to rise across the globe. Approximately 250 million people worldwide have diabetes, and type 2 accounts for up to 95% of all diabetes cases in the developed world.

Serious side effects continue to surface for existing drugs, though, forcing the FDA to revise the guidelines: All new drugs under developed will have to show that they do not increase the risk of cardiovascular events. The various glucose-lowering therapies currently under development will face tougher safety requirements. Drugs already on the market have stronger safety warnings, meaning that clinicians have fewer safe options. Additionally, recent evidence seems to point away from the use of treatments too aggressively.

Type 2 diabetes is characterized by insulin resistance, a condition in which fat, muscle, and liver cells don’t use insulin properly. People with type 2 diabetes are at increased risk for serious illnesses including cardiovascular disease, blindness, kidney failure, amputations, fractures, frailty, depression, and cognitive decline. In prospective epidemiologic studies, the incidence of many of these diseases is directly associated with the degree of hyperglycemia as measured by the plasma A1C (glycated hemoglobin) level. This is indicative of mean blood glucose level in the previous two to three months. The goal of diabetes therapy is to maintain the A1C level at about 7%, normal being about 6%.

Diabetes care is undergoing a rapid chance in which insulin is being prescribed earlier and for more conditions to delay the onset of full-blown disease, according to a study released this month by Scientia Advisors. In light of that trend, as more drugs go generic, companies offering more expensive medications will face resistance in markets, particularly those constrained by economics.

“We expect that as more drugs go generic, incretin mimetics (which increase insulin secretion) and insulins will generate an increasing share of the revenues,” noted Harry Glorikian, Scientia’s managing partner. “Therapies with benefits beyond glucose management (such as delaying the onset of diabetes or treating co-morbid conditions) will be used earlier in treatment. For a variety of reasons, despite the growing availability of new types of drugs, various forms of insulin will remain the gold standard.”

The Risk of Aggressive Therapy

Current treatment guidelines emphasize attainment of normal glucose levels through initial lifestyle intervention and metformin. Additional recommendations include rapid addition of medications, transition to new regimens when target glycemic goals are not achieved or sustained, and early addition of insulin therapy in patients who do not meet target goals.

Clinical trials have suggested, however, that aggressive insulin treatment targeted toward reaching normal or lower glucose levels may also pose problems in certain individuals. The interim results of the NIH-sponsored ACCORD (Action to Control Cardiovascular Risk in Diabetes) study is illustrative of the various complications in trying to achieve near-normal insulin levels. The trial compared a clinical strategy aimed at near-normal blood sugar levels to a strategy to reach more standard blood sugar levels as determined by A1C levels.

Standard treatments included any of the major classes of FDA-approved diabetes medications as prescribed by their study clinician: metformin, thiazolidinediones, insulins, sulfonylureas, exanatide, and acarbose. Combinations of medications could be used as needed to reach the treatment goal of a 7–7.9% decrease in A1C levels. Therapy for those in the intensive blood sugar group sought to achieve an A1C of less than 6%, similar to that of a person without diabetes.

The study evaluated the effects of intensively targeting blood sugar control among adults with established diabetes, high blood sugar levels, and pre-existing heart disease, or at least two cardiovascular disease risk factors in addition to diabetes.

In February NIH's National Heart, Lung, and Blood Institute (NHLBI) stopped the intensive blood sugar strategy after an average of 3.5 years of treatment instead of the planned 5.6 years due to safety concerns: The intensive strategy group had a 22% higher risk of death, or 54 more deaths than the standard group. The increased risk began emerging within one to two years after the strategy began to aggressively lower the participants' blood sugar levels.

“As compared with standard therapy, the use of intensive therapy to target normal glycated hemoglobin levels for 3.5 years increased mortality and did not significantly reduce major cardiovascular events,” the study investigators concluded. “These findings identify a previously unrecognized harm of intensive glucose lowering in high-risk patients with type 2 diabetes.”

Fewer Safe Options

Approaches to managing type 2 diabetes include recommendations for combination therapies that may include insulin and oral drugs or oral drug combinations. Issues with some currently used drugs may, however, further complicate drug choices for clinicians and patients. In September FDA revised the prescribing information for Merck & Co.’s Januvia (sitagliptin), a dipeptidyl peptidase IV (DPP-4) inhibitor, and Janumet (sitagliptin/metformin). The fact that there have been 88 reported cases of associated acute pancreatitis prompted the agency to recommend that doctors monitor patients for the condition after either initiating sitagliptin treatment or increasing the dose.

GlaxoSmithKline’s Avandia (rosiglitazone), a thiazolidinedione, carries a black box warning from the FDA due to its association with an increased frequency of heart attack. The agency decided not to remove the drug from the market after a 2007 advisory panel concluded that it was important for physicians to have rosiglitazone in their arsenal of treatments for type 2 diabetes.

In June the FDA suspended Takeda Pharmaceuticals application for alogliptin, another DPP-4 inhibitor, because clinical data did not meet certain statistical requirements outlined in its December 2008 guidance. The company expected to launch the drug in March 2010, but requirements for a new study will likely push plans back two years.

In July, though, the FDA approved Bristol-Myers Squibb and AstraZeneca’s DPP-4 inhibitor called Onglyza. Data from eight clinical trials did not show evidence of higher rates of heart attack, stroke, and other diseases. Despite these findings, the agency said it would require the companies to conduct a follow-up study of these diseases in high-risk patients including the elderly and those with existing heart conditions.

The partners’ other type 2 diabetes drug, Dapagliflozin, an SGLT2 inhibitor, has thus far met its primary endpoints of reducing A1C in two Phase III trials. The second study revealed that the drug increased the risk of urinary tract and genital infections; Onglyza comes with a similar increased risk for urinary tract infections, so how much this will affect approval is yet to be determined.

All this leaves physicians with the task of sorting out the best treatment as well as determining appropriate individual therapeutic goals. In 2008, results of a Veterans Administration study concluded that intensive blood glucose control yielded no significant effect on cardiovascular disease reduction. It was conducted among veterans with an average age of 60 at the outset of the 7.5 year study.

“Pharmaceutical companies and the American Diabetes Association continue to promote using glucose level-lowering drugs in type 2 diabetes mellitus to attain an HbA1c level below 7% despite recurring evidence of potential harm and scant evidence of benefit,” commented Stephen Havas, M.D., professor of epidemiology, University of Maryland at Baltimore School of Medicine, in a letter to the Annals of Internal Medicine.

After reviewing recent study results physicians at the Mayo Clinic concluded, “Some diabetes guidelines set low glycemic control goals for patients with type 2 diabetes mellitus (such as a A1C level as low as 6.5–7.0%) to avoid or delay complications. Our review and critique of recent large randomized trials in patients with type 2 diabetes suggest that tight glycemic control burdens patients with complex treatment programs, hypoglycemia, weight gain, and costs and offers uncertain benefits in return. We believe clinicians should prioritize supporting well-being and healthy lifestyles, preventive care, and cardiovascular risk reduction in these patients.”

Meanwhile, diabetes drug development will likely become more challenging as drug developers must now show that type 2 diabetes candidates do not increase risk of cardiovascular events based on formal statistical criteria. The new standard is in effect and impacts all drugs and biologics currently in development.

For more information about Avandia Side Effects or Avandia Lawsuit Information visit: http://www.ennislaw.com/avandia_lawyer.html

Newark woman sues maker of Yaz birth control

J Murawski — 2009-10-24T00:28:00Z

For more information about Yaz, Yasmin, or the generic version Ocella side effects visit http://www.ennislaw.com/yaz_lawyer.html

- Oakland Tribune

10/23/2009 - A 39-year-old Newark woman has filed a lawsuit this week against Bayer Corp., blaming its popular birth control product Yaz for causing her stroke and other related health issues.

Susan Galinis, the mother of 3-year-old twin girls, took the prescription-only product for four weeks in the summer of 2008, and wound up suffering a stroke that caused her to be hospitalized for six months, said her attorney.

The lawsuit was filed Monday in U.S. District Court in San Francisco.

Galinis had been taking the pills to help reduce premenstrual pains — which was one of the advertised uses, Danko said.

While hospitalized, Galinis had part of her skull temporarily removed because of excessive swelling in her brain. That portion of skull later was replaced, he said.

As a result of the stroke and related illness, Danko said, Galinis also suffered a diminished IQ — Danko said his client is now borderline mentally handicapped — and has experienced a change in her mood and speech.

"Her kids feel as though they have lost their mother," he said.

Galinis' suit attributed her health problems to Yaz.

The No. 1 selling birth control in the world, Yaz has been at the center of much criticism in recent years.

Galinis and more than 100 others have filed suit against the product's maker, claiming the drug presents additional health risks not associated with other birth-control pills, the suit said.

The Food and Drug Administration has admonished the makers of Yaz three times in recent years regarding the company's advertising campaign, the suit said.

In a letter issued to Bayer in October 2008, the FDA stated:

"The TV ads are misleading because they broaden the drug's indication, overstate the efficacy of Yaz, and minimize serious risks associated with the use of the drug."

The company has agreed to spend at least $20 million in recent years for corrective television advertisements to make women better aware of the products' side effects, according to published reports.

The ultimate goal of Galinis' lawsuits and others like it is to get the product off the market, the attorney said.

The San Mateo-based attorney said he also has filed a lawsuit on behalf of a Tracy woman who suffered health issues after taking the product.

In the days after the lawsuit was filed, Bayer released the following prepared statement:

"Bayer has received lawsuits relating to its drospirenone-containing oral contraceptives. The company is in the process of gathering information on these cases, but the complaints we have reviewed so far pertain to side effects that are warned about in our approved product labeling. Bayer will defend itself vigorously against these lawsuits.

"We will not comment on ongoing litigation or individual lawsuits."

For more information about Yaz, Yasmin, or the generic version Ocella side effects visit http://www.ennislaw.com/yaz_lawyer.html

Lawsuits Against Yaz Increasing

J Murawski — 2009-10-23T00:22:00Z

For more information about Yaz, Yasmin, or the generic version Ocella side effects visit http://www.ennislaw.com/yaz_lawyer.html

-empowerher

10/22/2009 - While all birth control pills have side effects, Yaz and its sister pill, Yasmin (which contains less estrogen) seems to be taking the cake for increasing lawsuits for its effect on women.

Courthouse News reports that Bayer faces 125 lawsuits against the Yasmin birth control pill. According to a recent complaint by Alishia Dianne Seagraves, "Yasmin and Yaz create 'unique and dangerous risks' for women because they contain a diuretic that has never been marketed in the U.S. and is unlike other progestins."

The complaint also states that the FDA warned Bayer multiple times about falsely portraying Yasmin/Yaz in commercials, downplaying how serious the risks were of the product.

Still, Bayer sponsored a study that reported exactly the opposite of what these lawsuits are claiming: that cardiovascular risks for women taking Yaz or Yasmin are the same as those who are taking other birth control pills. They also reported that pills with drospirenone (a progestin used in Bayer's oral contraceptives) are not more or less at risk for cardiovascular problems than women who took pills with another progestin, levonorgestrel.

Other studies dispute this, finding that women are at a higher risk for blood clots when taking drospirenone.

Is Yaz and Yasmin safe for women to use? This is the ultimate question. And it makes one weary to read about the increasing number of lawsuits piling up against Bayer from women who have faced extreme side effects as a result of taking either pill. One point it does raise is that it's imperative for companies to accurately discuss the side effects and risks of taking a particular product - misleading advertising that has portray Yaz as some kind of miracle drug with few side effects has surely been a reason for the pile up in lawsuits.

It's difficult to know exactly how Yaz or Yasmin will affect each individual woman. So as with all birth control pills, it's extremely important to read and research information yourself, and then speak to a medical professional about your own health and how the pill may affect your body.

Do you know someone who has faced critical issues with Yaz or Yasmin? Or have you been using it and find it works well? Share your story.

For more information about Yaz, Yasmin, or the generic version Ocella side effects visit http://www.ennislaw.com/yaz_lawyer.html

Pharmaceutical company behind Yaz forced to air corrective advertising

J Murawski — 2009-10-23T00:06:00Z

For more information about Yaz, Yasmin, or the generic version Ocella side effects visit http://www.ennislaw.com/yaz_lawyer.html

-Independent Florida Alligator

10/22/2009 - Back in 2008, pharmaceutical maker Bayer released a series of ads for Yaz, a birth control pill. The ads claimed that Yaz can treat various premenstrual symptoms and help clear up acne on skin.

But oops-they weren't supposed to say that. The FDAsaid that these ads made claims that it hadn't approved, and they didn't adequately disclose the health risks associated with Yaz.

So the FDA, along with 27 state attorneys general, cracked down on Bayer, requiring the company to spend $20 million on a corrective advertising campaign. The new ad campaign started in late January and is scheduled to end July 26, 2009.

The woman in the corrective ad says that we "might have seen some Yaz ads recently that were not clear" (if by "not clear" you mean "deceptive") and that "the FDA wants us to correct a few points in those ads" (if by "wants" you mean "required"). She goes on to make several corrections and clarifications. So everything's cool, right?

Not quite. To the uninitiated viewer, it may not seem like government-mandated corrective advertising at all. In fact, it might even look like any other contraceptive ad: it's set in a nightclub (with an establishing shot at the beginning!), with blandly hip-sounding music in the background, spoken aloud by a woman who's pretty cute.

So here's my problem: Corrective advertising is supposed to be retributive in addition to reparative. Companies that, either through deliberate deception or an irresponsible lack of diligence, mislead consumers should be embarrassed, and corrective advertising should be embarrassing.

These ads should have the text "This is a corrective advertisement ordered by the FDA because previous Yaz ads were deceptive" emblazoned on the screen, and, to drive home the point, the woman should have said something along the lines of, "We fully acknowledge we misled you in our ads before."

Knowing that you could be forced to run humiliating ads, out of your own pocket, is a pretty inspiring reason to be honest in your ads.

So what do you think? Was it clear these Yaz ads were, in fact, corrective ads? Should corrective advertising be embarrassing, or is that overkill?

Felicitas Rohrer wants the Yasmin family banned from the market. But, according to Ulrich Hagemann from the Federal Institute for Drugs and Medical Devices, a ban is unlikely.

"I think there is no good scientific reason as the third (generation of) oral contraceptives has been on the market for more than ten years and we now have a new type of oral contraceptive with the same risk," said Hagemann, referring to the Yasmin label. "You couldn't argue for taking these off the market and keeping the others on the market."

Risk not mentioned in package leaflet

The Coalition against Bayer Dangers therefore demands a complete ban of all third generation contraceptives with a higher thrombosis risk compared to the second generation. The Federal Institute for Drugs and Medical Devices is looking into changing the product information to reflect the new data coming from the recent studies.

"There is a need from my point of view to change the text" in the product information that accompanies the pills, said Hagemann.

According to the recent studies published in the British Medical Journal, second-generation contraceptives with the hormone levonorgestrel that have been used since the 1970s are currently considered the safest option for women who want to use birth control pills.

For more information about Yaz, Yasmin, or the generic version Ocella side effects visit http://www.ennislaw.com/yaz_lawyer.html

Bayer under pressure as birth control pills linked to blood clots

J Murawski — 2009-10-22T02:29:00Z

For more information about Yaz, Yasmin, or the generic version Ocella side effects visit http://www.ennislaw.com/yaz_lawyer.html

-Deutsche Welle

10/21/2009 - A hormone in some birth control pills made by Bayer may cause dangerous blood clots, studies have found. The pills have been linked to several recent deaths, but a ban is considered unlikely.

Birth control pills containing certain hormones like drospirenone are twice as likely to cause blood clots - or thrombosis - than older pills, according to two recent studies published in the British Medical Journal.

In Switzerland, a 21-year-old girl died in September after taking a drospirenone-containing contraceptive from Bayer's Yasmin line. In Germany, 25-year old Felicitas Rohrer collapsed in July with three thromboses in her lung. Since 2001, seven women in Germany have died while taking a contraceptive from the Yasmin family.

In total, 130 cases of adverse drug reaction have been reported to Germany's Federal Institute for Drugs and Medical Devices. However, not all of them are related to thrombosis, Ulrich Hagemann, head of the institute's department of drug safety, told Deutsche Welle.

Bayer denies higher risk factor

Birth control pills that contain the hormone drospirenone are particularly attractive to women since they promise less weight gain and clearer skin. But they also thicken the blood, thereby increasing the risk for thrombosis.

The Yasmin line offers five different contraceptives with the hormone: Yasmin, Yaz, Yasminelle, Aida and Petibelle.

Bayer said that it is known that the risk for venous thromboembolism, or blood clots in the veins, can be increased when starting the pill. Earlier studies funded by Bayer concluded that the drospirenone-containing pills held no higher risk than older, so-called second-generation pills.

But "arznei telegram," an independent publication for doctors and pharmacists, said the studies were not valid due to "massive method-related deficiencies."

Bildunterschrift: The second-generation birth control pills were introduced in the 1970s and the third-generation pills in the 1990s

Lawsuits in the US

Bayer, who earns 1.2 billion euros ($1.8 billion) from the worldwide sales of the Yasmin line, confirmed to Deutsche Welle that it currently faces 129 lawsuits in the United States, brought by women who say they've developed health problems after taking Yaz or Yasmin.

"Bayer is still in the process of gathering information on these cases, and the complaints we have received so far pertained to side effects that are warned about in our approved labeling and the labeling for other oral contraceptives," said spokesperson Friederike Lorenzen. "Bayer will defend itself vigorously against these lawsuits."

Critics like the Coalition against Bayer Dangers claim advertising focused too much on lifestyle factors like weight loss and skin appearance. A contraceptive should first and foremost work as a safe contraceptive, said Philipp Mimkes of the Coalition against Bayer Dangers.

"I got the first package in a nice little silver box with a mirror and make-up brush inside; it seemed very nice, so why shouldn't I take it? But I never heard that this pill has a much higher risk of pulmonary embolism than other pills," said Felicitas Rohrer.

Ban unlikely for Yasmin pills

Ulrich Hagemann from the Federal Institute for Drugs and Medical Devices said 20 out of 100,000 women who take an oral contraceptive from the second-generation, which were developed in the 1970s, develop thromoembolic symptoms. For the newer, third-generation pills - and also for contraceptives containing the hormone drospirenone, like Yasmin - women face a risk twice as high, with 35 to 40 women out of 100,000 experiencing thromboembolic effects each year.

"For the same dose of estrogen and the same length of use, oral contraceptives with desogestrel, gestodene, or drospirenone were associated with a significantly higher risk of venous thrombosis than oral contraceptives with levonorgestrel," concluded the Danish study in the British Medical Journal.

Felicitas Rohrer wants the Yasmin family banned from the market. But, according to Ulrich Hagemann from the Federal Institute for Drugs and Medical Devices, a ban is unlikely.

Risk not mentioned in package leaflet

"There is a need from my point of view to change the text" in the product information that accompanies the pills, said Hagemann.

Accutane trial continues with discovery, trial had been set for Oct. 19

J Murawski — 2009-10-22T02:21:00Z

For more information about Accutane Side Effects or Accutane Lawsuit information visit: http://www.ennislaw.com/accutane.html

- Madison County Record

10/21/2009 - What would have been Madison County's first trial involving acne medicine Accutane has been put off again as discovery in the case continues.

Plaintiff Jason Peipert filed notice of another deposition Oct. 13 as the defendants in the case have attempted to bar an unpublished study by the University of North Carolina.

Dr. Daniel Goran filed Oct. 9 to join his fellow defendants, Hoffman La Roche Inc. and Roche Laboratories, in opposing the inclusion of the study at trial.

Peipert deposed Dr. Paul Waymack in Washington D.C. on Oct. 6.

The trial had been set to open before Circuit Judge David Hylla Monday.

Peipert is suing Goran and the drug makers on negligence claims. He alleges that the drug, prescribed by Goran in 1999, caused him to develop bowel disease.

Accutane was taken off the U.S. market in June. The company indicated the decision was made "for business reasons during a reevaluation of our product portfolio of medicines that are now available from generic manufacturers, and is not being taken for reasons of safety or efficacy."

When the case was originally set for trial in 2007, it would have been the first Accutane suit to go to trial in the nation.

Peipert claims Goran negligently prescribed the drug because it is difficult to manage in patients.

Roche and fellow defendant Hoffman LaRoche Inc. are represented by John Galvin of St. Louis.

The case is Madison case number 03-L-2040.

For more information about Accutane Side Effects or Accutane Lawsuit information visit: http://www.ennislaw.com/accutane.html

Mingo couple suing over drug's side effects

J Murawski — 2009-10-21T02:06:00Z

For additional information about Reglan, Tardive Dyskinesia, or Reglan Lawsuit Information visit: http://www.ennislaw.com/tardive_dyskinesia_reglan.html

-WestVirginiaRecord

03/26/2009 - WILLIAMSON - A Mingo County couple is suing a physician and the makers of a drug used to treat reflux, alleging the companies concealed the risk of side effects and the physician failed to recognize the wife was suffering from two of them.

Shirlean and Elmer Meade filed a lawsuit in Mingo Circuit Court Feb. 25 against Dr. Deidre E. Parsley; Wyeth, Inc.; Schwarz Pharma; PLIVA, Inc.; Teva Pharmaceuticals; and six unnamed defendants.

Shirlean says she can no longer control her facial expressions, mouth, tongue and jaw because she used a generic version of the drug Reglan for more than 12 months to treat her reflux.

The conditions the woman is suffering from are called Tardive Dyskinesia and Akathisia, according to the complaint.

Elmer claims he's lost the consortium of his wife, according to the couple's 14-count complaint.

The complaint says Parsley began prescribing a generic form of Reglan to Shirlean in January 2006 for her reflux.

After taking the drugs, Shirlean failed to notice she was starting to show the signs of the onset of the conditions described in the complaint.

The Meades claim that Parsley failed to diagnose Shirlean's worsening condition and continue to prescribe her the Reglan through the end of February 2007.

Shirlean's conditions, allegedly side effects of long-term use of Reglan, weren't diagnosed until April 2, 2007, the complaint says.

The Meades claim that the makers of the name-brand Reglan knew that long-term use could cause these side effects, but concealed this information.

The makers of the generic form should have known of the alleged dangers of the drug, but relied on the information from the name-brand manufacturers for the prescription insert, the complaint says.

The Meades are seeking various actual and punitive damages in addition to legal fees.

For additional information about Reglan, Tardive Dyskinesia, or Reglan Lawsuit Information visit: http://www.ennislaw.com/tardive_dyskinesia_reglan.html

Generic Reglan Makers Lose Appeal Request in Vermont

J Murawski — 2009-10-21T01:57:00Z

For additional information about Reglan, Tardive Dyskinesia, or Reglan Lawsuit Information visit: http://www.ennislaw.com/tardive_dyskinesia_reglan.html

-Ennislaw.com /J.Murawski

04/22/2009 - A federal judge has handed four generic manufacturers of the heartburn medication Reglan another loss in their request to dismiss a product liability suit in Vermont. The ruling by Judge William Sessions of the U.S. District Court for the District of Vermont will not allow Actavis Elizabeth, Teva Pharmaceuticals USA, Pliva and Barr Pharmaceuticals to appeal a ruling that denied their motions for summary judgment and a stay of the proceedings in Ethel Kellogg v. Wyeth, et al., in which they are named among the defendents.

Reglan (metoclopramide) is prescribed for treatment of gastrointestinal disorders, and is only supposed to be used for under 12 weeks. However, it is often taken for extended periods of time. When used for extended periods of time or at high doses, Reglan side effects have been linked to an increased risk tardive dyskinesia. This condition causes repeated movements of the extremities and the face muscles. Some symptoms of tardive dyskinesia are lip smacking, tongue protrusions and rapid eye blinking.

The lawsuit against Reglan alleges that the risk of tardive dyskinesia was not adequately disclosed on the warning label and that the manufacturers were aware of the risks associated with long term use of their medications.

In February 2009, the FDA required that the manufacturers of all metoclopramide-containing drugs add a “black box” warning about the risk of tardive dyskinesia . The manufacturers were also required to develop a strategy to help ensure that patients are made aware of potential side effects of Reglan.

The makers of generic Reglan previously filed a motion for summary judgment in the Vermont case, arguing that they should be dismissed from the litigation because the plaintiff’s failure to warn claims are preempted by FDA regulations that require the generic version of medications to contain the same warning label as the branded version.

In December 2008, U.S. District Judge William K. Sessions III denied the motion to dismiss, and the drug makers filed a request for an interlocutory appeal to immediately challenge the Court’s decision and stay the proceedings.

In an order issued April 10, 2009, Judge Sessions denied the request. The generic drug makers will also be required to participate in discovery and further litigation of the case.

There are currently at least 15 Reglan tardive dyskinesia lawsuits involving similar claims pending throughout several districts in the United States. Plaintiffs in the claims have filed a petition with the U.S. Judicial Panel on Multidistrict Litigation to transfer the cases to one court for consolidated pretrial proceedings as part of an MDL.

For additional information about Reglan, Tardive Dyskinesia, or Reglan Lawsuit Information visit: http://www.ennislaw.com/tardive_dyskinesia_reglan.html

FDA issues 'Black Box Warning' in connection with prescribing Reglan

J Murawski — 2009-10-21T01:54:00Z

For additional information about Reglan, Tardive Dyskinesia, or Reglan Lawsuit Information visit: http://www.ennislaw.com/tardive_dyskinesia_reglan.html

-RenoGazetteJournal

05/13/2009 - It's wonderful when prescription medications cure ailments, but what happens when they cause adverse medical side effects? I'm angry because I appear to be suffering from permanent central nervous system damage associated with the prescribed drug Reglan (brand name for "metoclopramide") prescribed over a year ago for a digestive disorder.

I received a letter dated April 30 from my GI's office noting the FDA has placed a "Black Box Warning" on Reglan, explaining, it's possibly linked "with the development of a condition known as "tardive dyskinesia", a permanent condition that's untreatable.

TD is a disorder of the tongue, mouth and jaw, causing them to move uncontrollably in abnormal ways --the drug can also cause face jerking or involuntary body movements, including:

Repetitive movements of the extremities

Lip smacking, pursing, puckering

Grimacing

Tongue protrusion

Rapid eye movements

Impaired movement of fingers

"The movements are pretty much constant, except during sleep," reported Dr. Jeff Bronstein in a Los Angeles Times article. He's with the UCLA David Gaffen School of Medicine.

If you have taken Reglan or are taking it now, the FDA says it's time to call your physician whether you are experiencing side effects or not. Although some people's systems aren't seriously affected, the FDA notes, unhealthy side effects are becoming more commonplace.

People can go on-line and Google FDA Medical Watch for information, to report a reaction caused by Reglan or call their toll-free number 1-800-FDA-1088.

An FDA Black Box Warning gives a strong message to prescribers, mandating they take action, said a friend who is the head instructor at a respected medical clinic in California. That's why my doctor's office sent a warning missive to patients.

The LA Times story indicates Reglan, Octamide and Maxolon (metoclopramides) are frequently used nowadays for gastrointestinal malfunctions, or to ease nausea and vomiting. The drug blocks the body's release of the neurochemical dopamine.

I'm mostly angry because I wasn't informed of side effect possibilities, which were known. Why didn't my gastroenterologist warn me? Why didn't he give me a choice? Why, when I called him noting I was having tremors, did he recommend I cut the dosage in half? Why did I have to insist on an appointment to discuss my failing health?

I didn't realize I was lip smacking until Stony brought it to my doctor's attention. I thought a gland was overproducing saliva. At that time, the doctor said: "You are allergic to Reglan -- don't take it again." It was too late to stop some lip smacking and other disorders.

And worse, with Reglan's shoddy reputation, why did daughter Nicole's gynecologist recommend Reglan when she had morning sickness? She told her, "no way", recalling what happened to me.

Another Dayton friend, treated with Reglan for digestive disorders, was admitted to the hospital within 12 hours of her first dose.

Today, there are sores on my tongue, lesions inside my mouth, and inflamed gums because they are constantly being irritated by my wiggling tongue. Although my perplexed dentist writes prescriptions to help, it's nerve racking.

For additional information about Reglan, Tardive Dyskinesia, or Reglan Lawsuit Information visit: http://www.ennislaw.com/tardive_dyskinesia_reglan.html

Arkansas woman claims gastric drug led to dyskinesia

J Murawski — 2009-10-21T01:45:00Z

For additional information about Reglan, Tardive Dyskinesia, or Reglan Lawsuit Information visit: http://www.ennislaw.com/tardive_dyskinesia_reglan.html

-SoutheastTexasRecord

05/28/2009 - EL DORADO, Ark. - After a year of taking a drug to combat a medical condition involving paralysis of stomach muscles, an Arkansas resident started exhibiting abnormal muscle movements throughout her body.

Kecia Neal has filed suit against Teva Pharmaceutical, Schwarz Pharma and Wyeth Inc., the manufacturers of the drug Reglan and its generic equivalent metoclopramide. The product liability suit was filed on May 27, 2009, in the El Dorado Division of the Western District of Arkansas.

The drug Reglan is used to treat gastrointestinal disorders but has been linked to an increase risk of tardive dyskinesia, a condition that results in involuntary and repetitive movements of the body. Currently, there is no known treatment for tardive dyskinesia. In some patients, the syndrome's symptoms may be reduced in the weeks or months following the cessation of the drug.

Neal was taking the drug for treatment of gastroparesis.

The Food and Drug Administration required the drug's manufacturers to provide the addition of a boxed warning in February 2009. The new warning stated "chronic treatment with metoclopramide can cause tardive dyskinesia, a serious movement that is often irreversible."

In addition, the new warning stated "prolonged treatment (greater than 12 weeks) with metoclopramide should be avoided in all but rare cases."

The plaintiff states that she did not have access to these warnings and therefore, took the drug for more than a year. She states her use of the drug as prescribed resulted in overexposure and caused her to suffer serious, permanent and disabling injuries.

According to the lawsuit, nearly one-third of all patients who used the drug received a prescription for 12 months or longer, rather than 12 weeks or less. Those patients who took the drug for longer than 12 weeks are at a 100 times greater risk for the disorder and other similar side effects.

Neal argues that the defendants failed to warn doctors and patients of information within their knowledge and possession regarding the increased risk of debilitating side effects.

Further, the plaintiff argues that the defendants "encouraged the long term use of these drugs, misrepresented the effectiveness of these drugs and concealed the drug's dangerous side effects."

Causes of action filed against the defendants include negligence, strict liability, misrepresentation, fraud and breach of implied and express warranties.

The lawsuit alleges that the defendants failed to use due care in developing, testing, designing and manufacturing the drug, failing to provide proper or adequate warnings regarding the adverse side effects, failing to conduct adequate pre-clinical and clinical testing, and failing to adequately train medical providers regarding the appropriate use.

"Defendants breached these warranties (both express and implied) as the Reglan/metoclopramide was not merchantable, was unfit for its intended use and was unreasonably dangerous when comparing the benefits to the risks associated with its use," the complaint states.

The plaintiff is seeking damage for past and future medical expenses, physical pain and suffering, mental anguish, physical disfigurement, physical impairment, disability, psychological injury, loss of ability to provide household services, loss of earnings, and loss of earning capacity.

Arguing that the defendants "had actual, subjective awareness of the risks involved, but nevertheless proceeded with conscious indifference to the rights, safety or welfare of Plaintiff," the plaintiff is seeking punitive damages in excess of $75,000.

With the potential for numerous litigations against the drug, the case is expected to become part of a multi-district litigation (MDL-2049).

U.S. District Judge Harry F. Barnes is assigned to the litigation.

For additional information about Reglan, Tardive Dyskinesia, or Reglan Lawsuit Information visit: http://www.ennislaw.com/tardive_dyskinesia_reglan.html

Pulmonary Embolism Leads To Woman's Death After Using Birth Control Yaz - Yasmin

J Murawski — 2009-10-14T21:41:00Z

For more information about Yaz, Yasmin, or the generic version Ocella side effects visit http://www.ennislaw.com/yaz_lawyer.html

-EmaxHealth

10/13/2009 - Swissmedic, the medical regulatory agency in Switzerland, is looking into the death of a young woman who suffered a pulmonary embolism that appears to be a side effect of her birth control medication. According to the agency, the woman had been using Yaz, an oral medication made by Bayer Pharmaceuticals, for about 10 months when her death occurred in mid-September.

The cause of death was ruled pulmonary embolism, a blood clot that travels from another area of the body and blocks the main artery of the lung. The most common sources of the embolism are the lower extremities, which produce deep venous thrombosis (DVT’s). All estrogen-containing oral contraceptives carry an increased risk of the formation of DVT’s.

This is the second death that Swissmedic has investigated this year related to the oral contraceptive. The first death occurred in May 2009 and involved a 16-year-old girl who also suffered pulmonary embolism.

The FDA approved Yaz in 2006. It is a reformulated version of the Yasmin birth control pill first introduced in 2001. Because of concerns about safety, Yaz has a lower level of ethinyl estradiol (estrogen) than the original medication.

Yaz also contains drosperinone, which is a new type of progestin not found in any other oral contraceptive. The use of drosperinone has been linked to an increase in blood potassium levels, a condition called hyperkalemia, which can cause heart problems.

The FDA has received over 50 reports of deaths connected to the Yaz or Yasmin birth control pill since 2004. The deaths all involved young woman who suffered cardiac arrest, pulmonary embolism, and strokes. Hyperkalemia was often present at the time of death.

In 2008, the FDA sent Bayer a warning letter regarding its television ads, which were said to overstate its efficacy and promoted it for non-approved conditions, such as premenstrual syndrome. Bayer corrected the ads in February 2009.

In August of 2009, the FDA again warned the pharmaceutical maker regarding its findings of quality control deviations at its manufacturing plant in Germany. Per the regulatory agency, the facility did not meet US standards.

Bayer Pharmaceuticals currently has at least 74 lawsuits filed against the company related to complications suffered as a result of Yaz or Yasmin oral contraceptives. The complaints allege that the pharmaceutical company has failed to adequately research the product, fraudulently concealed the risk of injury, negligently failed to warn about the degree of risk, and misrepresented the safety in comparison with other products.

For more information about Yaz, Yasmin, or the generic version Ocella side effects visit http://www.ennislaw.com/yaz_lawyer.html

Deaths Linked To Trendy Birth Control Pill Yaz/Yasmin

J Murawski — 2009-10-14T21:32:00Z

For more information about Yaz, Yasmin, or the generic version Ocella side effects visit http://www.ennislaw.com/yaz_lawyer.html

-The Bulletin

10/12/2009 - It was mid-August, 2008, when 24-year-old Tanya Hayes began to experience breathlessness and what her family described as a “nasty, hard cough.” A busy student, Tanya ignored the symptoms until one afternoon when she collapsed in a car park in her hometown of Melbourne, Australia. Five hours later, she was pronounced dead of a pulmonary embolism.

According to the head of the emergency room that treated Ms. Hayes, her death was the result of “blood clotting caused by factors related to taking the oral contraceptive pill.”

What her heartbroken family did not discover until later is that the fine print on the package of pills she was taking, known as Yasmin, lists “breathlessness” as a "very rare . . . very serious side effect.”

“If we had read the pill’s directions more carefully . . . maybe we would still have Tanya here,” said Tanya’s mother, Genevieve Hayes.

Unfortunately, the Hayes family is not alone in their grief. According to a lawsuit filed in July 2009 by Cincinnati lawyer Janet G. Abaray on behalf of a woman who suffered a stroke after taking Yasmin, from the first quarter of 2004 through the third quarter of 2008, over 50 reports of death among users of Yasmin and Yaz have been filed with the Food and Drug Administration (FDA). Some deaths occurred in women as young as 17 years old.

Yasmin and its sister drug, Yaz, manufactured by Bayer Healthcare, are different from other combined hormonal birth control pills in that they contain drospirenone, a progestin that is unlike other progestins available in the United States. Pills containing drospirenone were never marketed in the United States before Bayer introduced Yasmin in April 2001, followed by Yaz in 2006.

According to Abaray’s lawsuit, studies done prior to FDA approval indicate that drospirenone has more dangerous side effects that other progestins. Specifically, drospirenone causes an increase in potassium levels in the blood which can lead to a condition known as hyperkalemia if the potassium levels become too high. Hyperkalemia can cause heart rhythm disturbances which can be fatal if left untreated.

Abaray said her firm, Burg, Simpson, Eldredge, Hersh and Jardine, has amassed evidence showing that there are many more adverse events reported to the FDA for Yaz and Yasmin than for other birth control pills that have been around longer.

For instance, besides the risk of blood clots, heart attack and stroke, other side effects of drospirenone include liver damage, depression or emotional changes, migraines, breast lumps, high blood pressure, high cholesterol and signs of allergic reaction including unexplained rashes, hives, itching, unexplained swelling, wheezing and difficulty breathing or swallowing.

"The drug companies have known [about the adverse effects] for some time,” Abaray said in an article appearing in the July 2009 issue of the National Law Journal, “and they have not warned the doctors or their patients."

Instead, Bayer has been investing millions in trendy ad campaigns that promote the drug to women under 35. The campaign resulted in $1.8 billion in worldwide sales last year – and some serious conflicts with the FDA.

Last October, the FDA sent a warning letter to Bayer citing the company for running false and misleading television ads about Yaz. Aside from minimizing serious risks associated with Yaz, the ads overstated the drug’s efficacy and promoted its use for conditions such as premenstrual syndrome for which it has not been approved.

Bayer agreed to spend $20 million on a corrective advertising campaign, but its costs could be much higher if suits such as the one filed by Anne Marie Eakins prove successful.

Ms. Eakins, 34, a history teacher from Grafton, Ohio, said the ads for Yaz which promised to help with period symptoms and acne problems prompted her to request the drug from her doctor. Shortly after starting the drug in 2007, she developed blood clots in both lungs and has lost partial use of her right lung as a result.

Even though the company admits that 74 lawsuits have been brought by women who say they developed serious health problems after taking Yaz or Yasmin, Bayer continues to defend the safety of Yaz and Yasmine.

The company cites a large-scale study in Europe which reported no difference in the risk of cardiovascular problems or death in women taking drospirenone birth control pills compared to women who took pills that contain levonorgestrel, a progestin that has been used in pills since the 1970s. However, it should be noted that this study was funded by Bayer.

Two other studies on Danish and Dutch women, published in the British Medical Journal last month, found a higher risk of venous blood clots for women taking newer progestins, including drospirenone.

"Bayer is committed to the ethical manufacture, marketing and distribution of our products. Patient safety is our top priority,” said Bayer spokesperson Rose Talarico to the National Law Journal. "All oral contraceptives contain clear labeling indicating the benefits and risks. Bayer stands behind the safety and efficacy of Yaz and Yasmin when used as directed. A woman and her health care professional should always discuss the benefits and potential risks of adverse health effects associated with all oral contraceptives."

For more information about Yaz, Yasmin, or the generic version Ocella side effects visit http://www.ennislaw.com/yaz_lawyer.html