Drug Safety Developments

Z-Pak linked to potential heart trouble

Quoted from http://www.myfoxatlanta.com/story/27949206/z-pak-linked-to-potential-heart-trouble

Z-Pak linked to potential heart trouble

Posted: Jan 27, 2015 7:40 AM EST By Kevyn Stewart, FOX 5 Medical Team

At 55, Hector Diaz, the owner of Carroll County takeout restaurant Latituude 33 works some pretty long hours. He says he can't really afford to take time off. So - twice - when he had a sinus infection - Diaz says he took this popular antibiotic, known as Z-Pak, or Zithromax.

"The peculiar thing was each time I took the medication, within 5 days. I had a heart attack," said Diaz.

Diaz doesn't what caused his two heart attacks, but his cousin - a doctor - told him about a 2012 study in the New England Journal of Medicine, that found the antibiotic may be linked to a very slight increase in heart rhythm problems - know as ventricular arthymias - that are associated with a increased risk of sudden cardiac death.

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Roche Ordered to Pay $18 Million to Former Accutane Users

Quoted from http://www.bloomberg.com/news/2012-06-29/roche-ordered-to-pay-18-million-to-former-accutane-users.html

Roche Ordered to Pay $18 Million to Former Accutane Users

By Jef Feeley - Jun 29, 2012 5:43 PM ET

Roche Holding AG (ROG) must pay a total of $18 million in damages to two former users of its Accutane acne drug who blamed the medicine for their bowel disease, a New Jersey jury ruled.

Jurors in state court in Atlantic City deliberated about six hours today before that finding officials of Basel, Switzerland-based Roche failed to properly warn Kathleen Rossitto and Riley

Wilkinson that Accutane could cause inflammatory bowel disease. Rossitto and Wilkinson were each awarded $9 million in compensatory damages. At the same time, the panel rejected claims by two other former users of the drug.

We are pleased that the jury found on behalf of Kathleen Rossitto and Riley Wilkinson and provided a measure of justice for the horrible injuries inflicted upon them by Roche’s drug,” David Buchanan, a New Jersey-based lawyer for the two plaintiffs, said in a telephone interview.

About 16 million people have taken Accutane, once Roche’s second-biggest selling drug, since it went on the market in 1982, according to plaintiffs’ lawyers. Roche, the world’s biggest maker of cancer drugs, pulled its brand-name version of Accutane off the market in 2009 after juries awarded millions of dollars in damages over bowel-disease claims.

Roche officials said they were pleased the jurors rejected claims by Rebecca Reynolds and Jason Young that Roche was responsible for their injuries. The company will appeal the awards to Rossitto and Wilkinson, they said.

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Roche Drug Trial Witness Dennehy Says Actor’s Loss a ‘Tragedy’

Quoted from http://www.businessweek.com/news/2011-03-11/roche-drug-trial-witness-dennehy-says-actor-s-loss-a-tragedy-.html

Roche Drug Trial Witness Dennehy Says Actor’s Loss a ‘Tragedy’

March 11, 2011, 12:04 AM EST

By Jef Feeley

March 11 (Bloomberg) -- The early end of James Marshall’s career, blamed by the actor and musician on Roche Holding AG’s Accutane acne drug, was an “unbelievable tragedy,” former co- star Brian Dennehy said in court.

Dennehy, who testified yesterday in the New Jersey trial of Marshall’s lawsuit against Roche, said 44-year-old Marshall was headed toward stardom before inflammatory bowel disease linked to the drug sidelined his career. Marshall played U.S. Marine Louden Downey in the 1992 movie “A Few Good Men.”

“This is an unbelievable tragedy,” Dennehy said in an interview outside the Atlantic City, New Jersey, courthouse. “It amazes me that something like this could have happened and could have had such a long-range effect on a career that should have topped.”

About 16 million people have taken Accutane, once Roche’s second-biggest-selling drug, since it went on the market in 1982, according to plaintiffs’ lawyers. Basel, Switzerland-based Roche, the world’s biggest maker of cancer drugs, pulled its brand-name version of Accutane off the market in 2009 after juries awarded millions of dollars in damages to former users over bowel-disease claims. Roche, which has lost all seven cases that have gone to trial, contends it didn’t pull the drug for safety reasons.

Marshall, a New Jersey native who now lives in Thousand Oaks, California, is seeking at least $11 million in damages for his Accutane-related injuries, including emergency surgery to remove his colon. Jurors are hearing claims by Marshall and two other ex-Accutane users that the drug destroyed their intestinal systems.

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Roche Ignored Accutane Risks, Actor’s Lawyer Tells Jurors

Quoted from http://www.bloomberg.com/apps/news?pid=newsarchive&sid=a0CU7WbJ6SXk

Roche Ignored Accutane Risks, Actor’s Lawyer Tells Jurors

By Jef Feeley - February 22, 2011 16:49 EST

Feb. 22 (Bloomberg) -- Roche Holding AG executives ignored research showing that the company’s Accutane acne drug causes inflammatory bowel disease, a lawyer told a New Jersey jury hearing a Hollywood actor’s claims over the medicine.

To protect profits, Roche researchers turned a blind eye to animal studies that found Accutane could cause bleeding and bowel blockages in users, said Michael Hook, an attorney for James Marshall, who played U.S. Marine Louden Downey in the 1992 hit movie “A Few Good Men.”

Jurors in state court in Atlantic City, New Jersey, are hearing claims by Marshall and two other ex-Accutane users that the drug destroyed their intestinal systems.

“These people have been seriously hurt,” Hook told the seven-woman, one-man jury today in opening statements.

About 16 million people have taken Accutane, once Roche’s second-biggest selling drug, since it went on the market in 1982, according to plaintiffs’ lawyers. Basel, Switzerland-based Roche, the world’s biggest maker of cancer drugs, pulled its brand-name version of Accutane off the market in 2009 after juries awarded millions of dollars in damages to former users over bowel-disease claims. Roche has lost all seven cases that have gone to trial.

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Roche Wins Reversal of $10.5 Million Accutane Verdict in New Jersey Case

Quoted from http://www.bloomberg.com/news/2010-08-05/roche-wins-reversal-of-10-5-million-accutane-verdict-based-on-judge-error.html

Roche Wins Reversal of $10.5 Million Accutane Verdict in New Jersey Case

By Jef Feeley - Aug 5, 2010 7:24 PM ET

Roche Holding AG won reversal of a $10.5 million verdict over its Accutane acne drug because a judge improperly barred the company from using evidence about the medication’s use, an appeals court ruled.

Roche’s lawyers should have been able to use data about how many acne sufferers had used Accutane over the years throughout Kamie Kendall’s 2008 trial of her lawsuit over the drug, the New Jersey Superior Court Appellate Division ruled today. The decision prompted a judge in Atlantic City, New Jersey, to delay the trial of an actor’s suit alleging the medication causes inflammatory bowel disease.

“Roche was unduly impeded at this trial from adducing and advocating numerical proofs that could have potentially and reasonably led a jury to reach a different verdict,” the appeals court said in an 89-page unpublished decision.

About 13 million people have taken Accutane, once Roche’s second-biggest selling drug, since it went on the market in 1982. Roche, based in Basel, Switzerland, lost patent protection on the drug in 2002 and continued to sell it along with generic competitors. In addition to bowel disease, Accutane has been linked to birth defects and depression.

Roche, the world’s biggest maker of cancer drugs, pulled its brand-name Accutane off the market in 2009 after juries awarded millions of dollars in damages to former users over the bowel-disease claims.

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Roche to Face Hollywood Stars in Accutane Trial

Quoted from http://www.businessweek.com/news/2010-07-30/roche-to-face-hollywood-stars-in-accutane-trial.html

Roche to Face Hollywood Stars in Accutane Trial

July 30, 2010, 12:43 PM EDT

By Jef Feeley

 

July 30 (Bloomberg) -- Roche Holding AG faces a lineup of Hollywood stars in the New Jersey trial of an actor’s lawsuit alleging he suffered the loss of his colon after taking the company’s Accutane acne drug.

James Marshall, who played U.S. Marine Louden Downey in the 1992 hit movie “A Few Good Men,” claims his acting career was derailed by his use of Accutane, which Roche no longer sells. Marshall will ask a jury to award at least $11 million in damages at a trial starting next week that will feature testimony from stars such as Martin Sheen and Brian Dennehy, according to court filings.

Sheen, Dennehy and director Rob Reiner will testify that Marshall, 43, was headed for stardom before bowel ailments allegedly caused by Accutane forced doctors to remove his colon, Michael Hook, the actor’s lawyer, said in an interview. Basel, Switzerland-based Roche faces thousands of lawsuits claiming it failed to warn patients that the drug could cause inflammatory bowel disease in some users, Hook said.

“The jury will hear that James Marshall had the potential to be the next James Dean-like star,” Hook said. “That dream is gone because he took something to treat acne.”

Roche said today that Accutane’s safety label has warned about the risks of inflammatory bowel disease for more than 20 years.

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More evidence ties acne drug to bowel disease

Quoted from http://www.reuters.com/article/idUSTRE6354OK20100406

More evidence ties acne drug to bowel disease

Tue Apr 6, 2010 3:19pm EDT

NEW YORK (Reuters Health) - Adding to evidence that the acne drug isotretinoin may lead to bowel disease in some users, a new study finds that patients on the medication were four times more likely than non-users to develop ulcerative colitis within a year.

Reporting in the American Journal of Gastroenterology, researchers say that the risk of any one isotretinoin user developing ulcerative colitis is "likely quite small."

However, the findings do strengthen the evidence of a cause-and-effect relationship between the acne drug and inflammatory bowel disease (IBD) -- a group of digestive disorders that includes ulcerative colitis and Crohn's disease.

Isotretinoin, which is used to treat severe acne, is probably best known by the brand-name Accutane. That drug was taken off the market last year in the face of competition from generic alternatives -- though in pulling the medication, maker Roche Pharmaceuticals also cited costs from defending personal-injury lawsuits.

Earlier this year, the company was ordered to pay $25 million in damages to a former Accutane user who claimed that the drug caused his IBD.

The company has maintained that there is no strong evidence that the acne drug triggers IBD. Between 1997 and 2002, 83 cases of IBD among isotretinoin users were reported to the U.S. Food and Drug Administration, but that does not prove that the drug itself is to blame.

For the new study, Dr. Seth D. Crockett and colleagues at the University of North Carolina Chapel Hill tried to test the cause-and-effect relationship.

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Roche Ordered to Pay $25 Million to Accutane User

Quoted from http://www.bloomberg.com/apps/news?pid=newsarchive&sid=aD5nslBfy8SE

Roche Ordered to Pay $25 Million to Accutane User

By David Voreacos and John Martin

 

Feb. 16 (Bloomberg) -- Roche Holding AG, the Swiss drugmaker, must pay $25.16 million in damages to a former user of its Accutane drug who blamed the acne medicine for his inflammatory bowel disease, a New Jersey jury ruled.

Andrew McCarrell, 38, won the verdict today at a retrial in Atlantic City, New Jersey. An appeals court ordered the new trial after overturning a $2.62 million award he won in May 2007. McCarrell, a computer technician from Birmingham, Alabama, testified he got sick after taking the drug for acne in 1995. He needed five surgeries, including one to remove his colon.

“I never thought it would be like this,” McCarrell said after the verdict in state Superior Court. “Never in my wildest dreams.”

The verdict today was the largest of six for Accutane users who won awards totaling $56 million. Roche lost every case, although a Florida appeals court overturned one of those judgments for $7.2 million. In each case, plaintiffs claimed Roche failed to warn adequately of the risks.

Roche stopped selling the drug in June 2009, citing generic competition and the high cost of defending personal injury lawsuits. Roche faces almost 1,000 other lawsuits over Accutane.

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New study may deal final blow to acne drug Accutane

Quoted from http://www.latimes.com/news/nationworld/nation/la-sci-accutane7-2009nov07,0,2567627.story

New study may deal final blow to acne drug Accutane

The study bolstered evidence of a link between the drug, pulled from the market in June, and inflammatory bowel disease. No medication is as effective in treating severe cases of acne.

By Shari Roan

November 7, 2009

Teenagers and young adults suffering from severe, scarring acne may ultimately lose the most effective treatment for the condition.

Swiss-based Roche Holding quietly pulled its blockbuster drug Accutane off the market in June amid early signs that the drug may be linked to inflammatory bowel disease. And last week, a study was released that quantified those risks, finding that users of the medication have almost twice the odds of developing a serious bowel disorder as nonusers.

For now, generic versions are still available, but the latest troubles could lead to the withdrawal of the controversial medication considered the treatment of last resort for acne so damaging it can lead to pitting of the face and a lifetime of anguish.

In its tumultuous 27-year history, the drug, also known as isotretinoin, has been found to cause serious birth defects if taken during pregnancy and to possibly increase the risk of depression, including suicidal behavior. Women who take it must register with the government, sign a consent form saying that they understand the medication's risks, use two forms of birth control, and submit to monthly pregnancy tests.

The fact that it's still on the market puzzles some former users and consumer advocates -- and reflects the profound lengths to which doctors, pharmacists, pharmaceutical companies, regulatory agencies and patients have gone to ensure its survival.

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Roche Pulls Accutane Off Market After Jury Verdicts

Quoted from http://www.bloomberg.com/apps/news?pid=20601087&sid=a7Oj2q25ZHZ8

Roche Pulls Accutane Off Market After Jury Verdicts

By Jef Feeley and Sophia Pearson

June 26 (Bloomberg) -- 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.

About 13 million people have taken Accutane since it went on the market in 1982. The medication was Roche’s second-biggest selling drug before the patent expired in 2002 and rivals started selling generic versions. Roche’s prescription market share of the drug is now below 5 percent, the company said.

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