Pharmaceutical Drug Litigation Updates

FDA panel votes to relax Avandia restrictions

Quoted from http://www.reuters.com/article/2013/06/06/us-avandia-fda-idUSBRE9540K120130606

FDA panel votes to relax Avandia restrictions

By David Morgan

WASHINGTON | Thu Jun 6, 2013 6:11pm EDT

WASHINGTON (Reuters) - U.S. health advisers voted on Thursday to recommend relaxing market restrictions on GlaxoSmithKline's diabetes drug Avandia, the former blockbuster at the center of one of the biggest drug controversies in recent years.

The vote, by a divided Food and Drug Administration advisory committee of outside health experts, could modestly enlarge the market for Avandia in the United States and lay the groundwork for further research into the drug's health risks. FDA will now take the vote into consideration for a final decision on how the pill also known by the generic name rosiglitazone can be used.

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Battleground FDA: How Tomorrow's Avandia Panel Could Help Shape The Future Of Diabetes

Quoted from http://www.forbes.com/sites/matthewherper/2013/06/04/battleground-fda-how-tomorrows-avandia-panel-could-help-shape-the-future-of-diabetes

Battleground FDA: How Tomorrow's Avandia Panel Could Help Shape The Future Of Diabetes

Matthew Herper, Forbes Staff , June 4, 2013

Avandia, once the best-selling diabetes pill on the planet, is now given only to a few thousand Americans. In much of the rest of the world it has been pulled from the market because of analyses that showed it might increase the risk of heart attacks. The controversy over the drug changed the way the Food and Drug Administration regulates diabetes medicines, resulting in steep requirements that new drugs prove they are unlikely to cause heart side effects.

Tomorrow, three years after an FDA advisory committee voted that Avandia’s use should be sharply curtailed or that the drug should be pulled, a new FDA advisory committee will take two days to reconsider that opinion. It’s possible that Avandia could go back into wider use, or that it could be withdrawn from the market entirely. Whatever happens could have far-reaching consequences for diabetes-focussed companies like Novo Nordisk, Sanofi, and Eli Lilly.

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Glaxo Findings on Avandia Safety Supported in Reanalysis

Quoted from http://www.bloomberg.com/news/2013-06-03/glaxo-findings-on-avandia-safety-supported-in-reanalysis.html

Glaxo Findings on Avandia Safety Supported in Reanalysis

By Anna Edney - Jun 3, 2013 10:21 AM ET

A second look at GlaxoSmithKline Plc (GSK)’s once-best-selling diabetes pill found it doesn’t increase overall cardiac death risk, U.S. regulators said.

Findings by London-based Glaxo that Avandia doesn’t raise the overall risk of death, heart attack or stroke appear to be supported in a reanalysis by independent researchers, some Food and Drug Administration staff said in a report today. FDA advisers will reconsider restrictions imposed on Avandia in 2010 at a meeting June 5-6, according to the report.

“It is important to note that FDA has not reached any final updated conclusions” on the cardiovascular safety of Avandia based on the reassessment, said Mary H. Parks, director of the FDA’s division of metabolism and endocrinology products.

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Second Thoughts on Safety of Avandia Stir a Dispute

Quoted from http://www.nytimes.com/2013/06/03/business/second-thoughts-on-safety-of-avandia-stir-a-dispute.html

F.D.A. to Reconsider Restrictions on Diabetes Drug

By KATIE THOMAS and SABRINA TAVERNISE

Published: June 2, 2013

Three years ago, in one of the more notable drug-safety scandals in recent history, the diabetes drug Avandia was all but banned from use in the United States after researchers found that thousands of people had heart problems after taking it. Today, it is a drug of last resort for people with diabetes who are so sick that a heart attack is worth the risk.

Dr. Steven Nissen, a cardiologist at the Cleveland Clinic, was the first to sound a public alarm about Avandia, as early as 2007.

But now, in a highly unusual move, the Food and Drug Administration has decided to reopen the case on Avandia and will ask a panel of experts this week whether the agency must reconsider the restrictions on the drug.  

That is just one of several options before the advisory committee, but lifting the limits would amount to a major policy reversal and could be a huge victory for the drug’s maker, GlaxoSmithKline. Avandia was once a top-selling drug, reaching more than $3 billion in sales in 2006 before controversy flared. It could also help rewrite one of the most embarrassing chapters in the F.D.A.’s recent history.

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GSK Playing Hardball With UK Families Over Avandia Litigation

Quoted from http://guardianlv.com/2013/01/gsk-playing-hardball-with-uk-families-over-avandia-litigation/

GSK Playing Hardball With UK Families Over Avandia Litigation

Added by GM on January 30, 2013.

 

Avandia Patients that have pending litigation in the United Kingdom may not be getting due compensation anytime soon, for those lawsuits against GlaxoSmithKline, (GSK) the manufacturer of the Avandia brand of Rosiglitazone, a diabetes drug discovered to increase risk factors for stroke and heart attacks in diabetics.

A study published in 2007 indicates that Rosiglitazone may increase fatalities from heart disease by as much as 43%.

Products containing Rosiglitazone, like Avandia, were pulled from the market in Europe in September 2010, but continue to be sold in the United States, under specific guidelines put forth by the U.S. FDA.

The European Medicines Agency (EMA) made recommendations in September 2010 that the drug be pulled from the European marketplace, and it is no longer sold there.

According to the FDA, Rosiglitazone may have been responsible for over 100,000 heart attacks in the U.S. alone, with no figure currently available for the U.K. or Europe.

GlaxoSmithKline, (GSK) has admitted to hiding evidence indicating the adverse side effects of Avandia, such as increased risk of heart disease, heart attack, stroke, bone fractures, macular edema, and hepatitis.

GlaxoSmithKline, (GSK) currently has settled over 3 billion dollars in lawsuits in the U.S., with estimates running as high as 6 billion dollars by the time all lawsuits are settled.

Product liability lawsuits in the U.K. are another matter all together.

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Diabetes Drugs Avandia, Actos Linked to Vision Woes

Quoted from http://health.usnews.com/health-news/news/articles/2012/06/11/diabetes-drugs-avandia-actos-linked-to-vision-woes

Diabetes Drugs Avandia, Actos Linked to Vision Woes

They may raise risk of macular edema, researchers report

June 11, 2012

By Steven Reinberg
HealthDay Reporter

MONDAY, June 11 (HealthDay News) -- British researchers report that thiazolidinediones, diabetes medications that are used to help control blood sugar levels, may cause eye problems in those who take them.

The drugs that fall into this group include Avandia and Actos, which have been tied to increased risk of heart attack in the case of Avandia and bladder cancer in the case of Actos. Now it is possible that these drugs may also cause diabetic macular edema, the study authors said.

"Patients who received a thiazolidinedione were at two- to three-fold increased risk of developing macular edema," said lead researcher Dr. Iskandar Idris, an associate professor in diabetes medicine at the University of Nottingham.

However, the risk of macular edema is very small, about 0.2 percent, so the increased relative risk translates into an absolute risk of less than 1 percent.

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Glaxo Settles Almost 25,000 Avandia Cases Under Mediation

Quoted from http://www.businessweek.com/news/2012-02-15/glaxo-settles-almost-25-000-avandia-cases-under-mediation.html

Glaxo Settles Almost 25,000 Avandia Cases Under Mediation

February 15, 2012, 12:46 AM EST

By Sophia Pearson

 

Feb. 14 (Bloomberg) -- GlaxoSmithKline Plc settled almost 25,000 cases over its Avandia diabetes drug in mediation as multidistrict litigation begins to wind down, lawyers told a federal judge in Philadelphia.

In November, U.S. District Judge Cynthia Rufe appointed a mediator to preside over settlement negotiations. She also set a 75-day deadline to resolve 85 percent of the remaining cases. While it was unclear in a court hearing today whether lawyers met the threshold, Rufe called the effort “a major success.”

“Mediation will no longer be the focus of this court’s effort,” Rufe said. “We will resolve the remaining cases through litigation.”

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Glaxo Settles 20,000 Lawsuits Over Avandia, Lawyer Says

Quoted from http://www.businessweek.com/news/2012-02-01/glaxo-settles-20-000-lawsuits-over-avandia-lawyer-says.html

Glaxo Settles 20,000 Lawsuits Over Avandia, Lawyer Says

February 01, 2012, 3:16 PM EST

By Jef Feeley

 

Feb. 1 (Bloomberg) -- GlaxoSmithKline Plc, which is paying $3 billion to resolve government claims that it illegally marketed drugs such as the Avandia diabetes medication, agreed to settle more lawsuits over the pills, a lawyer said.

Glaxo, the U.K.’s biggest drugmaker, agreed last month to resolve more than 20,000 cases alleging Avandia causes heart attacks, said Paul Kiesel, a lawyer for former users. The accord, reached in court-ordered mediation, included a case that was set for trial in state court in Los Angeles, he said.

“We are pleased the mediation has successfully resulted in the settlement of a significant number of the remaining cases,” Kiesel, one of the lead lawyers for plaintiffs in the Avandia litigation, said yesterday in a telephone interview.

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Glaxo Facing Mediation Push to Resolve Avandia Lawsuits

Quoted from http://www.bloomberg.com/news/2011-11-08/glaxo-facing-mediation-push-to-resolve-avandia-lawsuits-1-.html

Glaxo Facing Mediation Push to Resolve Avandia Lawsuits

By Jef Feeley - Nov 8, 2011 3:34 PM ET

GlaxoSmithKline Plc (GSK), which has agreed to pay $3 billion to resolve claims it illegally marketed its Avandia diabetes drug, is facing a judge’s push to resolve most of the remaining patient lawsuits over the medication.

U.S. District Judge Cynthia Rufe said yesterday she appointed a mediator to “preside over settlement negotiations” for an unspecified number of Avandia cases consolidated before her in Philadelphia. Rufe set a 75-day deadline to resolve 85 percent of the remaining cases, according to court filings.

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Takeda, Glaxo Diabetes Treatments Raise Risk of Eye Disease, Study Finds

Quoted from http://www.bloomberg.com/news/2011-06-24/takeda-s-actos-glaxo-s-avandia-raise-risk-of-eye-disease.html

Takeda, Glaxo Diabetes Treatments Raise Risk of Eye Disease, Study Finds

By Elizabeth Lopatto - Jun 24, 2011 5:00 PM ET

Takeda Pharmaceutical Co.’s Actos, the world’s best-selling diabetes treatment, and GlaxoSmithKline Plc. (GSK)’s Avandia raise the risk of an eye disease that can lead to blindness, a study shows.

People taking the drugs have a 3 to 6 times increased risk of developing diabetic macular edema, a condition in which the retina thickens and swells, according to a study of more than 100,000 people to be presented Sunday at the American Diabetes Association’s annual meeting in San Diego.

Diabetic eye disease is the most common cause of blindness in working-age Americans, according to the National Eye Institute. Macular edema damages the retina and can eventually cause blindness. The best way to prevent the side-effect of diabetes is to keep blood sugar under control, according to the National Eye Institute.

“Patients at high risk of sight-threatening DME should avoid” the class of drugs including Actos and Avandia, the study authors, led by Richard Donnelly at the University of Nottingham, wrote in their study abstract. High-risk patients include those who have poor control of their blood sugar and those with a previous history of macular edema.

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