Ennis & Ennis, P.A. Blog
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Ennis & Ennis, P.A. Blog
Diabetes drugs can lead to heart failure - Avandia Side Effects
06/25/2009 - A latest study has revealed how a certain category of diabetes drugs can actually increase the risk of heart failure. The class of drugs under study were thiazolidinediones (TZDs).
TZDs linked to heart failure
Thiazolidinediones (TZDs) have been a topic of controversy since 2007 when an examination of Avandia (rosiglitazone), a TZD made by GlaxoSmithKline, showed that patients consuming it have a higher probability of getting affected by a heart attack.
Statistics have also revealed that TZDs are associated with heart failure. The consumption of this class of drugs leads to a condition wherein the heart is not able to pump sufficient blood throughout the body.
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Roche Pulls Accutane Off Market After Jury Verdicts
06/27/2009 - Roche Holding AG, the world’s biggest maker of cancer drugs, is pulling its Accutane acne medicine from the U.S. market after juries awarded at least $33 million in damages to users who blamed the drug for bowel disease.
Roche notified the U.S. Food and Drug Administration today that it was withdrawing Accutane after a “reevaluation” of its product lines showed it faced serious challenges from generic competitors, company officials said in a statement.
“In addition, Roche has been faced with high costs from personal-injury lawsuits that the company continues to defend vigorously,” according to the statement.
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Smell-Loss Drug Escaped FDA Review Under Homeopathic Label
06/27/2009 - Carol McDaniel blames her permanent loss of smell on the Zicam nasal spray, a cold remedy she thought would be safer than other medicines because it was sold as homeopathic.
Zicam’s homeopathic label allowed it to be marketed for a decade without a review for safety or effectiveness by the U.S. Food and Drug Administration, until its recall on June 16. Doctor and consumer reports to the FDA and Zicam’s maker, Matrixx International Inc., showed the Zicam nasal sprays and swabs may have caused more than 900 people to lose their sense of smell, U.S. regulators said June 16.
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Zicam recall: Manufacturer pulls intranasal cold remedy
06/25/2009 - That which we call a rose by any other name would smell as sweet—unless you’re one of the hundreds of people who say they lost their sense of smell after using intranasal Zicam cold remedies.
On June 16, the Food and Drug Administration cautioned consumers to stop using the following products: Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Gel Swabs and the already-discontinued Kids Size Zicam Cold Remedy Swabs. ...<< MORE >>
On June 16, the Food and Drug Administration cautioned consumers to stop using the following products: Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Gel Swabs and the already-discontinued Kids Size Zicam Cold Remedy Swabs. ...<< MORE >>
Gardasil. The vaccine that almost killed me, and maybe you.
06/03/2009 - If you have been following me for some time now you would have noticed I have lost a lot of weight, been traveling and seeing lots of doctors lately and been super health conscious. Did you ever hear of the vaccine called Gardasil. You know the one you see commercials for on tv every five minutes and that is given out in schools. If I had gotten the third installment of that vaccine I would not be alive to tell you about it. ...<< MORE >>
Two Hydroxycut Class Actions Filed: Suits follow recall of liver-damaging dietary supplement
05/26/2009 - Two class action lawsuits have been filed in the wake of the recall of Hydroxycut, a popular weight-loss supplement that has been linked to liver damage and other life-threatening side effects.
The suits, filed in Canada and Tennessee, accuse Iovate Health Sciences, which manufactures Hydroxycut, of failing to warn of the drug's dangers or take proper precautions to protect its users.
Hydroxycut was voluntarily recalled on May 1 after the Food and Drug Administration (FDA) identified numerous health risks posed by the drug. The Administration received 23 complaints of liver damage resulting from use of the product, ranging from jaundice to the need for a transplant. A 19-year-old man died in March 2007 from liver failure apparently caused by Hydroxycut; amazingly, the death was not reported to the FDA until March of this year. ...<< MORE >>
The suits, filed in Canada and Tennessee, accuse Iovate Health Sciences, which manufactures Hydroxycut, of failing to warn of the drug's dangers or take proper precautions to protect its users.
Hydroxycut was voluntarily recalled on May 1 after the Food and Drug Administration (FDA) identified numerous health risks posed by the drug. The Administration received 23 complaints of liver damage resulting from use of the product, ranging from jaundice to the need for a transplant. A 19-year-old man died in March 2007 from liver failure apparently caused by Hydroxycut; amazingly, the death was not reported to the FDA until March of this year. ...<< MORE >>
Hydroxycut hazard: The popular bodybuilding and weight-loss supplement has been linked to liver damage, but it's uncertain how many have suffered harm.
06/01/2009 - It was a case that might have puzzled TV's acerbic Dr. House.
A 33-year-old woman with dark urine and yellowish skin complained of profound fatigue when she showed up at the emergency room at Yale-New Haven Hospital. Lab tests showed she had acute liver inflammation.
Joseph Lim, a liver specialist at Yale, was on the case. He noted that the woman had been taking Hydroxycut supplements for weight loss for two weeks. Several reports in the medical literature had linked Hydroxycut (which is used for both bodybuilding and weight loss) to liver damage. ...<< MORE >>
A 33-year-old woman with dark urine and yellowish skin complained of profound fatigue when she showed up at the emergency room at Yale-New Haven Hospital. Lab tests showed she had acute liver inflammation.
Joseph Lim, a liver specialist at Yale, was on the case. He noted that the woman had been taking Hydroxycut supplements for weight loss for two weeks. Several reports in the medical literature had linked Hydroxycut (which is used for both bodybuilding and weight loss) to liver damage. ...<< MORE >>
Ennis & Ennis P.A. Announces Launch of New Hydroxycut Recall Website
05/28/2009 - Ennis & Ennis P.A. announces the launch of a new website to assists users of Hydroxycut products due to the voluntary recall by the manufacturer, Lovate Health Sciences, Inc. This new Hydroxycut recall website will give consumers up-to-date news and legal developments related to the recall. Also Ennis & Ennis is announcing free legal consultations to consumers of Hydroxycut products to advise them of their legal rights. ...<< MORE >>
FDA requires black box warning-Reglan may cause permanent injury!
04/15/2009 - The U.S. Food and Drug Administration announced drug makers are now required to place a black box warning on all metoclopramide containing drugs like Reglan. Federal regulators must warn patients, healthcare professionals and medication consumers about the risk of serious injury in long-term or high-dose use of all metoclopramide containing drugs. << MORE >>
Wyeth Supreme Court Loss Breaks Drug Lawsuit Logjam
04/30/2009 - Just two months after the U.S. Supreme Court decided patients can sue drugmakers over injuries from medicines approved by the government, long-stalled lawsuits against GlaxoSmithKline Plc and Bristol-Myers Squibb Co. are again moving toward trials.
The March 4 decision in a case on Wyeth’s nausea treatment Phenergan broke a logjam of cases in state and federal courts. Federal regulatory approval of a medicine and information about side effects doesn’t shield drugmakers from claims that patients and doctors weren’t adequately warned, the high court ruled. The decision already affected more than 250 lawsuits involving at least 10 companies that were in limbo before the ruling.
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FDA issued Hydroxycut product injury warning after liver injuries and one death
05/05/2009 - The U.S. Food and Drug Administration issued a stop product use directive on May 1, 2009. All consumers are urged to stop using Hydroxycut health products which are sold and marketed to U.S. consumers as weight loss supplements. According to federal regulators with the FDA one person has died from use of the over the counter diet pill plus reports of 23 serious injuries. << MORE >>
Injuries Prompt Evenflo High Chair Recall: Evenflo Recalls About 733,000 Envision and Majestic High Chairs Because of Fall Risk, Choking Hazard
About 733,000 Evenflo high chairs are being recalled because of fall risk, choking hazard, and reports of injured children.
The recall includes all Evenflo Envision high chairs and also certain models of Evenflo Majestic high chairs.
Evenflo Envision High Chairs
The recalled Evenflo Envision high chairs include the following model numbers: 2891321, 2891321A, 2891333, 2891351, 2891351A, 2891365, 2891375, 2891403, 2891403A, 2891466, 2891466A, 2891478, 2891536, 2891536A, 2891573, 2891586, 2892351 and 2892351A.
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FDA Warns Consumers to Stop Taking Hydroxycut Products
05/02/2009 - WASHINGTON -- Consumers should "immediately stop" using Hydroxycut weight-loss products amid concerns they may cause jaundice and liver failure, the U.S. Food and Drug Administration said Friday.
The FDA has received 23 serious reports of health problems with Hydroxycut products and one death in a 19-year-old male who had used the weight-loss products, said Linda Katz, interim chief medical officer in the FDA's food safety and nutrition division. ...<< MORE >>
The FDA has received 23 serious reports of health problems with Hydroxycut products and one death in a 19-year-old male who had used the weight-loss products, said Linda Katz, interim chief medical officer in the FDA's food safety and nutrition division. ...<< MORE >>
Info about the Maytag recall
03/11/2009 - Here are the details of the refrigerator recall announced by the Maytag Corp. and the Consumer Product Safety Commission.
It includes certain Maytag®, Jenn-Air®, Amana®, Admiral®, Magic Chef®, Performa by Maytag® and Crosley® brand side by side and top freezer refrigerators.
They have model and serial numbers printed on a label located on the top middle or left upper side of the refrigerator liner and have the following model and serial number combinations:
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Maytag Recalls About 1.6 Million Refrigerators Due To Fire Hazard
03/11/2009 - Maytag Corp. and the U.S. Consumer Product Safety Commission on Tuesday announced a voluntary recall of about 1.6 million refrigerators because of a fire hazard.
Maytag, which was bought by Whirlpool Corp. (WHR) in 2007, said the recall affected Maytag, Jenn-Air, Amana, Admiral, Magic Chef, Performa and Crosley brand side-by-side and top-freezer refrigerators. Refrigerators with freezers on the bottom aren't included in the recall.
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Gastrointestinal drug gets 'black box' warning
Late last month, the Food and Drug Administration ruled that makers of the drug metoclopramide must put the strongest so-called black-box warning on the product's package insert. Also sold as Reglan, Octamide and Maxolon, metoclopramide is used to treat certain gastrointestinal problems. If taken chronically, it can cause a serious neurological disorder called tardive dyskinesia (TD). << MORE >>
ETHEX Recalls More Oversized Drugs
ETHEX Corp. has announced another recall of oversized tablets. This time, the company is recalling a single lot of Hydromorphone HCl 2 mg tablets. According to the Food & Drug Administration (FDA), Hydromorphone is a drug used for pain management and is packaged under the ETHEX label in 100-count bottles. The ETHEX Hydromorphone recall involves Lot #90219, Exp: 03/2010; NDC #58177-0620-04. ETHEX has initiated recall notifications to wholesalers and retailers nationwide who have received any inventory of the recalled lot of this product with instructions for returning the recalled product. If they have not already done so, they are urged to contact ETHEX regarding procedures for returning the recalled product. If consumers have any questions about the recall, they should call ETHEX or their physician, pharmacist, or other health care provider. << MORE >>
Ex-employees tell of 'filthy' conditions at Georgia peanut processing plant:
David James recalled opening a container of peanuts at the processing plant here and seeing baby mice. "It was filthy and nasty all around the place," said James, who worked in shipping.
Terry Jones, a janitor, remembered the roof that constantly leaked rain.
James Griffin, a cook at the plant, recounted this simple rule: "I never ate the peanut butter, and I wouldn't allow my kids to eat it."
In interviews, these men and another employee from the now-closed plant provided a glimpse into the day-to-day operations at Peanut Corp. of America.
Federal officials are investigating the plant in connection with an outbreak of salmonella poisoning that has sickened nearly 600 people in more than 40 states. Eight may have died because of it.
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Peanut company lied on salmonella testing, FDA finds.....
Peanut Corp. of America, the company that produced the contaminated peanut butter now being widely recalled, lied to Food and Drug Administration investigators about shipping batches of the food known to be tainted with salmonella bacteria, the agency said Friday.
The company had previously told the FDA that some lots of peanut butter had initially tested positive for the bacterium, then were retested and found to be negative before they were shipped. But further investigation showed that the company actually shipped some of the lots before the second tests were completed. Other lots were shipped without testing and, in some cases, no second test was performed even after the first one came back positive. The lots were shipped to a vast array of food manufacturers and found their way into such items as cookies, crackers, health bars, ice cream and dog biscuits. Peanuts and ...<< MORE >>
Spiriva Linked to Increased Heart Attacks and Strokes
Last week, a study in the Annals of Internal Medicine found a 34% increased risk of dying from a heart attack or irregular heartbeat in COPD patients using ipratropium, which is in the same class as Spiriva, compared with those using albuterol, another COPD drug, or using nothing. The study focused on veterans diagnosed before Spiriva was approved in 2004. << MORE >>
Avandia Death Risk Higher Even When Compared with Actos
New data suggests that even when Avandia is compared with Actos, another diabetes drug in the same class of medications, it carries an increased risk of congestive heart failure and death. Avandia and Actos are both diabetes drugs that are part of the same class of medications, known as thiazolidinedione agents. A “black box” warning was added to both medications in August 2007 about potential side effects which may increase the risk of congestive heart failure. << MORE >>
J&J To Pay $16.6M For Duragesic Patch Death
A jury in an Illinois state court awarded the money to the family of Janice DiCosolo, 38, who died in February 2004, because the patch she was wearing delivered a fatal dose of the fentanyl narcotice, which is the main ingredient in Duragesic, Bloomberg News reports. This if J&J’s fourth loss in as many trials over the past two years and it took the jury less than two days to deliberate. The patch, by the way, is made by Alza and distributed by Janssen Pharmaceutica, and generated $1.16 billion in sales last year for J&J, making Duragesic one of its best-selling products, the news service writes. << MORE >>
Months of Pain Following Zimmer Hip Implant
Don. K knows first-hand the pain of a Zimmer Hip replacement gone wrong. He had a Zimmer Durom Cup implanted in his hip that required replacing shortly after his original surgery. Although his hip is much better now, Don faced months of pain, repeated surgeries and time off work to deal with complications from his Zimmer Durom hip implant. << MORE >>
Urgen Recall Notice: ReliOn Diabetic Insulin Syringes Recalled
Covidien and FDA notified patients and healthcare professionals of a recall of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles. The mislabeled syringe may result in patients receiving an overdose of as much as 2.5 times the intended dose, with serious health consequences, low blood sugar, and even death.<< MORE >>
Supreme Court Preemption Oral Argument
IN THE SUPREME COURT OF THE UNITED STATES - - - - - - - - - - - - - - - - - x WYETH, :
Petitioner :
v. : No. 06-1249 DIANA LEVINE. : - - - - - - - - - - - - - - - - - x
Washington, D.C. Monday, November 3, 2008
The above-entitled matter came on for oral argument before the Supreme Court of the United States at 10:06 a.m. APPEARANCES: SETH P. WAXMAN, ESQ., Washington, D.C.; on behalf of
the Petitioner.
EDWIN S. KNEEDLER, ESQ., Deputy Solicitor General, Department of Justice, Washington, D.C.; on behalf of the United States, as amicus curiae, supporting the Petitioner.
DAVID C. FREDERICK, ESQ., Washington, D.C.; on behalf of the Respondent.
1
C O ...<< MORE >>
FDA Official Tells Senators Agency Can't Keep Up
Portfolio Media, New York (April 24, 2008) The U.S. Food and Drug Administration is not currently able to handle the demands of regulating an increasingly global pharmaceutical supply chain, Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, told a Senate panel Thursday.
The FDA has traditionally been configured as an agency to regulate a domestic industry," Woodcock said. "The FDA of the last century is not configured to regulate this century's globalized pharmaceutical manufacturing industry."
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"Kugel Mesh Patch Really Affected My Life"
Patients who have the Kugel Mesh Patch implanted to repair their hernia may have to undergo another surgery to have the hernia patch taken out. That's because the patch may be defective, causing serious injury to some patients. Evelyn B. has been told that she has to have a second surgery to take out her mesh. She doesn't have insurance, so it took a long time before she found out why she had so much pain following her hernia surgery. << MORE >>
Why I won't let my girls have these cancer jabs
As thousands of young girls across Sussex undergo a series of jabs to protect them against cervical cancer, one mother has urged parents to educate themselves about the risks involved. Reporter Samuel Underwood talks to her about why she is concerned about the vaccine and why her daughters will not been immunised. << MORE >>
Champix, a Slow-ticking Time Bomb
It’s not just the smokers who are suffering but also those supporting them in their effort. Here is a quote from one of our female readers: “... our relationship is at risk. All the symptoms of depression, suicide, upset stomach, fatigue, muscle pain, paranoia, lack of sex drive, etc...has taken a huge toll...” << MORE >>
Kugel Mesh Patch: "People Who Get Shot Feel Better than I Do"
John H has suffered though a lot of pain, and many surgeries due to a hernia repair where a hernia patch was used to repair one of his herniated areas. Many of his symptoms and health problems following his hernia repair surgeries are consistent with those experienced by people who have had Kugel Mesh Patches implanted. << MORE >>
That Must Be Bob. I Hear His New Hip Squeaking.
The first time John L. Johnson’s artificial hip squeaked, he was bending down to pick up a pine cone in his yard in Thomasville, Ga. Mr. Johnson looked up, expecting to find an animal nearby. O’Toole, a nutritionist at Montefiore Medical Center in the Bronx, who first squeaked going up stairs after getting home from her hip-replacement surgery in 2005, said she thought the banister she was gripping needed repair. << MORE >>
1.6 Million Ford Windstars Investigated for Fire Hazard
Federal safety regulators have expanded their investigations of Ford Motor Company vehicles that are in danger of erupting into flames to include the 1995 to 2003 Windstar minivan.
As many as 1,643,432 Windstars were produced by Ford between 1995 and 2003 and are covered by the investigation described as an engineering analysis, according to the National Highway Traffic Safety Administration (NHTSA) Web site.<< MORE >>
Hernia Repair Patches: "Sick of Feeling Sick"
If you thought you were safe from hernia repair problems because you do not have a Kugel Mesh patch implanted, you may want to think again. Tracy B. does not have the Kugel Mesh Hernia Patch implanted. What she does have is the Bard Ventralex hernia patch, which according to her doctor is a "cousin" to the Kugel Mesh patch. Like patients with Kugel Mesh patches, Tracy is having problems with her hernia repair patch and requires surgery to have it taken out. << MORE >>
FDA Approved Drug brings Some to Suicide!
Pfizer, the drug manufacturer of Chantix, faces numerous lawsuits which state that this specific drug has caused many of its users to have serious side effects, even that of suicide. Approved by the FDA, Chantix is taken to help individuals quit smoking, but at what cost? << MORE >>
Potential Problems With Gardasil Reported
BOSTON -- It has been on the market two years. In that time, the government has received almost 10,000 complaints about Gardasil, the controversial cervical cancer vaccine. << MORE >>
"Levaquin has ruined my life in so many ways"
Therese was prescribed the antibioitic Levaquin in 2001 when she experienced shortness of breath, but just 3 days after taking Levaquin, she couldn't bend her wrists, knees or ankles. Luckily, Therese had the wherewithal to stop taking the drug; others have not been so fortunate. << MORE >>
Bisphosphonates for Osteoporosis Treatment Linked to Jawbone Damage
Osteoporosis drugs are not without possible adverse effects, including a condition in which jawbone tissue dies.
“Bisphosphonate-related osteonecrosis of the jaw is a mouthful, pun intended,” says Dr. Thomas B. Dodson, an expert on oral and maxillofacial surgery a Massachusetts General Hospital. << MORE >>
First MDL Levaquin Tendon Rupture Lawsuits Could be “Trial-Ready” by Jan 2010
A status conference was held earlier this month before U.S. District Judge John R. Tunheim, who is overseeing the federal Levaquin litigation consolidated in Minnesota. At that time,
lawyers for Johnson & Johnson and lawyers for plaintiffs who have filed Levaquin lawsuits alleging tendon damage caused by the popular antibiotic, indicated that they expect the first MDL cases to be
“trial-ready” by January 2010.
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What’s the Story with FOSAMAX
That is a complex question for which there is no easy answer. However, it might help for us to gain a basic understanding of Fosamax’s composition; the specialized way that it works;
and how the body eliminates Fosamax. It would also be interesting to address any specialized concerns about how Fosamax reacts with the specialized bone that makes up the jaw.
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Fosamax Linked to Serious Abnormal Bone Fractures
On March 20, 2008, The New England Journal of Medicine published a physician group report of 15 women taking Fosamax who experienced "atypical low-energy fractures," which means their
bones broke doing almost nothing – a serious kind of injury typically seen in very elderly individuals in declining health. The fact that the NEJM is reporting this is a major wake up call to anyone
who hasn't figured out that Fosamax is dangerous to your health.
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Avandia: "This Medicine Is Deadly"
Sam P. is happy to no longer be taking Avandia. He says he suffered severe side effects shortly after starting the medication, although he did not realize Avandia could have been
causing his health problems. Luckily, he learned the truth and stopped taking the drug. Unfortunately, damage was already done to his heart.
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Avandia Heart Attack
After being on Avandia for two years, Gail suffered a heart attack. When she was admitted to hospital, immediately following her heart attack, the doctors did an
angiogram and found that all the arteries were blocked. Gail had to have five stents put in, which required two separate operations.
Today, nearly a year later, her life is totally different. Her ability to work has been dramatically affected, and she is concerned about her financial well-being.
Gail has type 2—or non-insulin dependent diabetes. Her doctor put her on Avandia to help control her blood glucose levels. But she experienced chest pains while she was on the drug, dizziness and
blurred vision. Gail didn’t really think anything of these symptoms at the time. << MORE >>
Woman warns others not to use NuvaRing
Birth control product blamed for 12 deaths; hundreds of lawsuits filed.
Misty Liebert had been using a new birth control product for three weeks when she awoke at 2 a.m. on March 22 choking and gagging.
She dashed to the bathroom, lights still out, and began coughing up something in the sink. << MORE >>
NuvaRing Suspected in Mother's Death
She was young, healthy and fit; a runner and a vibrant mother of two. So it was a complete shock when, one morning in February of 2006, 31-year-old Rosana Mariconda
collapsed onto her bed while getting ready for work. She died of a stroke, and her husband Frank suspects the NuvaRing birth control device she was using.
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A Warning About NuvaRing
A woman has suffered blood clots caused by NuvaRing, a transparent vaginal ring that provides month long birth control. The ring releases a continuous, low dose of estrogen and
progestin for 21 days. Since NuvaRing hit the market seven years ago, it has been the subject of hundreds of lawsuits related to blood clots. Twelve deaths across the nation have been attributed to
NuvaRing.
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Yamaha Rhino Recall: Side-by-Side RUV Rollovers
Yamaha has sent direct mail notifications to owners of the recalled Rhino side-by-side recreational utility vehicle (RUV). However, some people who have changed addresses or purchased
a used Yamaha Rhino may still not be aware of this potentially dangerous recall.
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Yamaha Motor Corporation U.S.A. recalls Rhino side-by-side vehicles
The following product safety recall was voluntarily conducted by the firm in cooperation with the CPSC. Consumers should stop using the product immediately unless otherwise instructed.Name of Product: Model Year 2008 Rhino YXR450 and YXR700 Side-by-Side VehiclesUnits: About 7,800Distributor: Yamaha Motor Corporation U.S.A., of Cypress, Calif.Manufacturer: Yamaha Motor Manufacturing Corp. of America, of Newnan, Ga.Hazard: The brake caliper on the left front wheel could have been made incorrectly, resulting in brake fluid leaking. This can cause a loss of braking and control of the vehicle, posing a serious safety risk to the driver and passenger.<< MORE >>
Get the facts about Gardasil
Do health officials really know what's best for our children? If so, then why are some of them campaigning for a vaccine, mostly geared toward 11- and 12-year-old girls, that's
supposed to protect them against a sexually transmitted disease?
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FDA steps up Cipro warnings
After the anthrax attacks of 2001 Cipro became a household word when it was identified as a drug that could fight that deadly bacteria.
Recently, Cipro was in the spotlight again as federal regulators imposed their most urgent safety warning on Cipro and similar antibiotics because of increased risk of tendinitis and tendon
rupture.
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Avandia –Two Weeks to Near Death
Dennis is just 40 years old. He was diagnosed with type 2 diabetes and was put on Avandia. But after only two weeks on the drug, Dennis experienced shortness of breath
and chest pains. He had a heart attack and he thinks Avandia could have been the cause.
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