Drug Safety Developments

FDA: Don't Use Pradaxa Blood Thinner in Patients With Artificial Heart Valves

Quoted from http://health.usnews.com/health-news/news/articles/2012/12/20/fda-dont-use-pradaxa-blood-thinner-in-patients-with-artificial-heart-valves

FDA: Don't Use Pradaxa Blood Thinner in Patients With Artificial Heart Valves

Warning based on European trial showing increased risk for strokes, heart attacks in this group

December 20, 2012

THURSDAY, Dec. 20 (HealthDay News) -- The blood thinner Pradaxa should not be used to prevent stroke or blood clots in patients with mechanical heart valves, the U.S. Food and Drug Administration said in a warning issued Wednesday.

As the agency noted, a clinical trial in Europe was halted recently because patients taking Pradaxa (dabigatran) were more likely to suffer strokes, heart attacks and clots forming on their mechanical heart valves than patients who were taking the older blood thinner warfarin.

Patients in the study who were taking Pradaxa also had more bleeding after valve surgery, the agency said.

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Vertex Pharmaceuticals discloses hep C drug deaths

Quoted from http://www.bizjournals.com/boston/blog/bioflash/2012/12/vertex-discloses-hep-c-drug-deaths.html

Vertex discloses hep C drug deaths

Boston Business Journal by Julie M. Donnelly, Reporter

Date: Wednesday, December 19, 2012, 9:23am EST

Vertex Pharmaceuticals (Nasdaq: VRTX) has announced that a number of patients have died from serious skin reactions after taking the company’s hepatitis C therapy Incivek.

The U.S. Food and Drug Administration has added a so-called “black box” warning to Incivek’s label today saying that fatal and non-fatal serious skin reactions have been reported in patients taking Incivek combination treatment.

The company stressed the importance of halting therapy after a serious skin reaction is identified, as the fatal cases were the result of staying on therapy even after experiencing a serious reaction.

Rash and serious skin reactions are known side effects of Incivek, and have been previously reported. However this is the first time the company has reported that such reactions have resulted in fatalities. The company did not disclose how many patients died.

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Stop-smoking drug Chantix may carry heart risks, FDA warns

Quoted from http://www.courier-journal.com/article/20121214/PRIME01/312150017/Stop-smoking-drug-Chantix-may-carry-heart-risks-FDA-warns

Stop-smoking drug Chantix may carry heart risks, FDA warns

12:10 PM, Dec 14, 2012 |

 

Robert Preidt

HealthDay

People who take the prescription quit-smoking drug Chantix may be at higher risk for cardiovascular problems, and doctors should weigh the risks of the drug against it benefits, the U.S. Food and Drug Administration said.

A major review of clinical trials that compared patients who took Chantix (varenicline) to patients who took a placebo found that those who took the drug had slightly higher rates of serious cardiovascular events such as nonfatal heart attack, nonfatal stroke and cardiovascular-related death, according to an FDA drug safety communication .

However, the increased risk among people taking Chantix was not statistically significant, which means that it is unclear whether their increased risk was due to the drug or due to chance, the agency added.

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FMC says U.S. wrongful death lawsuits to be consolidated

Quoted from http://www.reuters.com/article/2012/12/13/fmc-lawsuits-idUSWEB171120121213

FMC says U.S. wrongful death lawsuits to be consolidate

FRANKFURT | Thu Dec 13, 2012 1:57am EST

FRANKFURT Dec 13 (Reuters) - Fresenius Medical Care, the world's largest dialysis group, said a group of plaintiffs in the United States had moved to consolidate wrongful death lawsuits against the company over its NaturaLyte and GranuFlo products.

The suits generally allege that the two products carried inadequate labeling and warnings, causing harm to patients, FMC said, adding that it considered the suits to be without merit and was vigorously defending against them.

The company's chief executive Ben Lipps said in a statement that FMC's actions related to the products were appropriate and responsible.

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Boehringer Sued by Hundreds Over Bleeding Tied to Pradaxa

Quoted from http://www.bloomberg.com/news/2012-12-11/boehringer-sued-by-hundreds-over-bleeding-tied-to-pradaxa.html

Boehringer Sued by Hundreds Over Bleeding Tied to Pradaxa

By Jef Feeley & Margaret Cronin Fisk - Dec 11, 2012 12:00 AM ET

Harold Asher never thought to ask why his wife’s doctors prescribed Boehringer Ingelheim GmbH’s blood thinner Pradaxa after she recovered from a stroke.

Barbara Jean Asher took Pradaxa for three months to cut her risk of suffering another stroke. Then, in June 2011, she was rushed to a hospital with internal bleeding that proved fatal, her family said in a lawsuit blaming Ingelheim, Germany-based Boehringer for her death. Asher, 72, a grandmother from a suburb of Palm Springs, California, died when doctors couldn’t stop the hemorrhaging, the family said.

“My generation, you do what your doctor tells you,” Harold Asher, 77, said in a telephone interview on her switch to Pradaxa from an older type of blood thinner. “You don’t ask any questions.”

Hundreds of patients and their families are questioning whether Boehringer executives knew Pradaxa posed a deadly risk to some patients when they brought the drug to the U.S. market in October 2010. Unlike older blood thinners, researchers said, Pradaxa has no antidote to reverse its effects, which can lead to so-called bleed-out deaths.

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J&J Wins Reversal of $1.1 Million Levaquin Punitive Award

Quoted from http://www.bloomberg.com/news/2012-11-30/j-j-wins-reversal-of-1-1-million-levaquin-punitive-award.html

J&J Wins Reversal of $1.1 Million Levaquin Punitive Award

By Margaret Cronin Fisk - Nov 30, 2012 2:38 PM ET

Johnson & Johnson won a reversal of $1.1 million in punitive damages awarded to a man who claimed the company failed to properly warn of the risks of tendon damage linked to its antibiotic Levaquin.

While erasing the punitive award, the U.S. Court of Appeals in St. Louis sustained a Minnesota jury’s 2010 finding that J&J failed to warn plaintiff John Schedin. The court also upheld an award of $630,000 in compensatory damages to Schedin, who sued J&J and its Ortho-McNeil-Janssen Pharmaceuticals unit in 2008.

“The evidence is neither clear nor convincing, as a matter of law, that OMJP deliberately disregarded the safety of the users of Levaquin,” U.S. Circuit Judge William Jay Riley said today. Proving deliberate disregard is “required for punitive damages under Minnesota law,” Riley said.

J&J has faced more than 3,400 state and federal lawsuits alleging tendon injuries from Levaquin, according to court filings. The company had settled about 845 of them by last month, according to an Oct. 30 filing in federal court in Minneapolis, where a judge is overseeing about 1,900 Levaquin lawsuits.

The New Brunswick, New Jersey-based company has won three of the four Levaquin cases that have gone to trial. Schedin’s case was the only such victory for the plaintiffs.

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