Ennis & Ennis, P.A. Blog

Yaz Side Effects: FDA Warning Letters

J Murawski — 2009-11-18T04:31:00Z

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

-InjuryBoard

11/17/2009 - The Food and Drug Administration (FDA) has sent several warning letters to Bayer HealthCare Pharmaceuticals, Inc. for what the FDA termed “misleading” advertising spots it found “particularly troubling” because they served to “undermine the communication of important risk information, minimizing these risks and misleadingly suggesting that Yaz is safer than has been demonstrated by substantial evidence or substantial clinical experience.”

In the 8-page FDA Warning Letter regarding Yaz dated October 3, 2008 two TV ads were cited as overstating the efficacy of the drug and minimizing the risks and side effects associated with using Yaz. Yaz related lawsuits allege that the warnings were inadequate in fully describing the potential side effects including heart attacks, strokes, gallbladder disease, deep vein thrombosis, pulmonary embolism, cardiac arrhythmias and sudden death. The FDA sent three letters to the makers of Yasmin and Yaz regarding the potential for hyperkalemia in high-risk patients and their failure to clarify that risk.

2003 Yaz/Yasmin FDA Warning Letter

2008 Yaz/Yasmin FDA Warning Letter

2009 Yaz/Yasmin FDA Warning Letter

Yaz and Yasmin have been very popular among young women due to Bayer's "particularly troubling" advertising targeting young women and unconfirmed "benefits" of these birth control pills.

However, these drugs -- Yaz, Yasmin and Ocella -- have been linked to potentially deadly side effects, including heart attack, stroke, pulmonary embolism (PE), deep vein thrombosis (DVT) and gallbladder trouble.

These serious side effects are caused by a key chemical found in Yas, Yasmin and Ocella -- Drosperinone.

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

US judge requests mass tort status for Yasmin birth control pill claims

J Murawski — 2009-11-15T23:25:00Z

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

-Michelmores Medical Negligence News

11/13/2009 - With the growing numbers of claims in the US alleging an increased risk of pulmonary embolism and other severe side-effects from the oral contraceptive Yasmin, a court in New Jersey has requested that the actions be centralised and given mass tort status.

The US litigation includes three "fourth generation" oral contraceptives Yasmin and Yaz products manufactured by Bayer Healthcare Pharmaceuticals and Ocella manufactured by Barr Pharmaceutical Companies. Women who have filed claims in various States allege that they have suffered strokes, DVTs and other problems including raised potassium levels which may increase the risk of complications for women with a range of conditions including obesity, renal problems, diabetes, chronic high blood pressure or a history of stroke and DVT.

The claims allege that the drugs contain oestrogen and progesterone, which suppress ovulation and prevent pregnancy. It is alleged that they also contain drospirenone, an ingredient not found in other oral contraceptives which is alleged to differ from other progesterones in the US and not previously marketed in this country before its use in these 3 drugs. Drospirenone has been associated with health risks not seen in other forms of the hormone. In August 2009 the British Medical Journal published two studies identifying an increased risk of venous blood clots for women taking drospirenone when compared with women who had taken other oral contraceptives. The BMJ referred to 40 cases in which women had suffered venous thrombosis, including one involving the death of a 17 year old. The BMJ reports that the Dutch College of General Practitioners has recommended that its members prescribe the older forms of second generation birth control pills rather than Yasmin and Yaz. Between 2004 and 2008 in excess of 50 deaths associated with the use of Yasmin and Yaz have been reported to the US FDA. On 5 August 2009 the US Food & Drug Administration issued a warning letter to Bayer after it was alleged to have used low-quality batches of drospirenone from a plant in Germany.

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

Birth control dangers

J Murawski — 2009-11-15T23:16:00Z

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

11/12/2009 - Within the past year both Christine Navarro and Robyn Dunn were rushed to the hospital with life threatening blood clots. At the time Christine was taking the Yaz birth control pill and Robyn was taking its sister birth control drug Yasmin.

Both of these women were young and athletic and blame birth control for their brushes with death.

It's common knowledge that all women's oral contraceptives carry a percentage risk of health complications. But attorney's who've filed lawsuits on behalf of Robyn and Christine contend that Yaz and Yasmin from Bayer carry a greater risk.

These attorneys claim that recent study in the British Medical Journal found increased risk from the drug drospirenone unique to Yaz and Yasmin.

Representatives for Bayer, the maker of Yaz and Yasmin responded to the concerns, saying quote: "Patient safety is Bayer's top priority. Bayer's oral contraceptives have been and continue to be extensively studied and tested worldwide. Bayer reaffirms and stands behind the safety of its drospirenone containing oral contraceptives."

Doctor Ronald Johnson has prescribed oral contraceptives for his patients for 25 years including Yaz and Yasmin in recent years without issue.

"My personal experience has been that I have never had a patient that had blood clots, or pulmonary embolism, or a stroke, from taking birth control pills."

Still, Johnson says every woman should receive fair warning from her doctor.

"Every single person who takes birth control pills is at some risk of increased clotting. Is it a risk to be at a dangerous level? For the vast majority it is not."

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

Daily Dose: The Mysterious Disappearing Accutane

J Murawski — 2009-11-15T23:08:00Z

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

-Woman’s Day

11/14/2009 - Ever since my early 20s I’ve been fortunate to have decent skin (I consider it payback for having pretty bad breakouts during my teen years), but I’ve known several people for whom topical creams just weren’t enough to combat blemishes. That’s when they turned to Accutane (isotretinoin), an oral medication that works wonders for the skin but is known for major side effects, including serious birth defects. (Women can only get it if they agree to take birth control pills and submit to pregnancy tests before each prescription gets refilled.) Still, most of my friends seemed to think it was well worth the trouble. So imagine my surprise when one friend (and former user) told me that Roche, the pharmaceutical company that originally developed Accutane, quietly pulled the product from the market over the summer.

It turns out the makers of brand name Accutane decided it was costing them more money than they were making off of it. That’s mainly because the patent ran out (so there are now cheaper generic options), but also because the company was getting hit with one too many personal injury lawsuits. The last straw: patients claiming that the drug causes inflammatory bowel disease—a link that some scientific studies have confirmed.

You can still get this medication in generic form (at least for now)… but would you want to? That’s something for you and your doctor to decide, but consider yourself warned.

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

Toyota to fix accelerators in huge US recall

J Murawski — 2009-11-15T22:58:00Z

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

-Reuters

11/15/2009 - Toyota Motor Corp will soon offer to fix the accelerator pedals of up to 4 million vehicles in the United States that are subject to the company's largest ever safety recall, Kyodo News reported on Saturday.

Toyota is believed to have agreed with U.S. authorities to voluntarily repair the accelerator pedals, Kyodo said, citing sources familiar with the matter.

But Toyota spokesman Hideaki Honma denied that the company had reached an agreement with the U.S. National Highway Traffic Safety Administration and said the talks were proceeding.

Toyota, the world's top automaker, said in late September it would recall some 3.8 million vehicles in the United States because of the risk that a loose floormat could force down the accelerator, a problem suspected of causing crashes that killed five people.

Toyota has said that the cost of any related repair work have no effect on its business as the company has set aside nearly 500 billion yen ($5.6 billion) in provisions for recalls.

Kyodo said the company had opted to offer to fix the accelerator pedals rather than issue a separate recall as it believes the pedals' shape is not a defect.

The carmaker is now in the final stage of arranging the move with the U.S. NHTSA, Kyodo cited the sources as saying.

The recall will cover the Camry and Avalon sedans, the Prius hybrid, the Tacoma and Tundra pickup trucks and luxury Lexus models, the IS250, the IS350 and the ES350.

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

Roche stops marketing Accutane over IBD link

J Murawski — 2009-11-12T03:42:00Z

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

-The Examiner

11/11/2009 - Accutane a sobriquet of the formal isotretinoin, a type of vitamin A, that has been manufactured since 1982.

During its registered patent that ended in 2002, was linked to serious birth defects. Women who took it had to sign a consent form, prescribed two forms of oral contraceptives, submit to monthly pregnancy tests, and register with the government.

Assuredly, it was labeled with warnings to that effect. Among them dehydration, dry skin, joint and muscle pain, elevated cholesterol and liver toxicity, and possible depression that may have lead to Rep. Bart Stupak (D-Mich.) teenage son to commit suicide after taking Accutane.

Although, like others there is no proof of association between suicidal behavior and the powerful acne medication, but to the parents victims the FDA has been pressed to take it off the shelves. The exacting iPledge program demands that all doctors, pharmacists and patients join a risk-management registry to ensure that females do not become pregnant while taking Accutane was put into effect in 2005 by the Food and Drug Administration.

The evidence noted in last weeks annual meeting of the American College of Gastroenterology in San Diego, after the Swiss-based Roche Holding manufacture of the highly effective treatment for nodular acne, which can cause acne in the skin the size of pencil erasers or larger, was striped from the pharmucuetical market in late June.

The reason being is the prescription showed a link of inflammatory bowel disease in people taking the medicaton. Many researchers from the University of North Carolina, Chapel Hill, presenting a high rate of bowel disorders overall just under 2 times the odds to develop such diseases.

People who filled four or more prescriptions had an even higher risk of 2.67 times. And the odds of having ulcerative colitis among isotretinoin users was 4.36 times more likely. The comparison of 8,189 cases of inflammatory bowel disease with 21,832 healthy individuals was conducted by Dr. Seth Crockett and his colleagues. The drug is sometimes prescribed for psoriasis, lupus, various types of cancer among others.

Though Crockett stated, only about 5 to 10 people in 100,000 are diagnosed with inflammatory bowel disease each year. The data have not yet been in a peer-reviewed journal, Crockett noted, they must be considered preliminary. The fear of developing IBD is that it may result in partial or complete removal of the rectum and colon.

Roche Holding said its decision to withdraw Accutane reflected market pressures and the cost of lawsuits. Plaintiffs have won an estimated $33 million in judgments against Roche over bowel disorders as claimed by Dermatology Times, an industry publication. Isotretinoin is usually taken daily for up to six months and a cure in about 70% of patients results.

This was Roche's best-seller with about $200 million a year in sales and over 13 million people around the globe have used Accutane.

"The absolute risk is very low," Dr. Crockett said. "So if someone has disfiguring acne... it might be a risk they are willing to take."

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

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."

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

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.

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

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
http://www.ennislaw.com/toyota_floor_mat_recall.html

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.

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

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.

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

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.

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

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.

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

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