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Avandia Linked to Long List of Health Woes

Oct 15, 2009 | Parker Waichman LLP Avandia continues to be linked to serious heart problems.  The  controversial diabetes drug has also been associated with other dangerous side effects, including liver failure and bone fractures.

Avandia (Rosiglitazone) is prescribed to treat people with type 2 diabetes.  It controls blood sugar by making the body more sensitive to the action of insulin.   Avandia was first sold in the U.S. in 1999, and became a blockbuster for GlaxoSmithKline, quickly becoming its biggest selling product.  By 2006, Avandia's total sales were $3.4 billion.

Avandia’s cardiovascular side effects first became the subject of concern in May 2007, when an analysis of 42 clinical trails published by the Cleveland Clinic showed that patients taking the drug had a 43-percent higher risk of having a heart attack. That summer, GlaxoSmithKline and the Food & Drug Administration (FDA) came under fire for an apparent failure to warn the public about the cardiac risks associated with Avandia. In November 2007, a warning detailing Avandia’s association with myocardial ischemia was added to the drug’s boxed warning.

Other studies have since continued to raise concerns about Avandia side effects.  For instance, a study involving 30,000 diabetic patients published in the  November 24, 2008 issue of The Archives of Internal Medicine found elderly Avandia patients were at higher risk of death than people taking other diabetes medication   All of the patients in the study were over 65;  49.7 percent of these patients had been prescribed Avandia and 50.3 percent were treated with Actos.  Within a year 1,869 of the patients had died.  Among the patients who had been prescribed Avandia, the rate of death was 15 percent higher than in those prescribed Actos.

And just last month, a Canadian study was published in the British Medical Journal found that elderly patients taking Avandia were at a higher risk of suffering heart failure.  That study involved 39,494 patients, aged 66 and older, who were started on either Avandia or Actos between April 2002 and March 2008. Researchers in Toronto, Ontario found that patients treated with Actos had a 23 percent lower risk of being hospitalized for congestive heart failure, and a 14 percent lower risk of death from any cause.  During the six-year study period, 5.3 percent of patients taking Actos and 6.9 percent taking Avandia either died or were hospitalized for heart attack or congestive heart failure.

The study’s principle investigator, Dr. David Juurlink, a scientist at the Institute for Clinical Evaluative Sciences in Toronto, and head of the division of clinical pharmacology and toxicology at Sunnybrook Health Sciences Centre, told the Calgary Herald that the increased risk from Avandia could be significant. “If a million patients were treated with rosiglitazone (Avandia) rather than pioglitazone (Actos), these results imply that we would see more than 8,000 excess admissions for heart failure, and more than 3,000 additional deaths from any cause,” Juurlink said

Avandia has also been linked to other side effects.  In October 2008, the group Public Citizen said it had identified 14 cases of Avandia-induced liver failure in the FDA’s Adverse Event Reporting System.  Of the 14 cases of  liver failure, 12 resulted in deaths.  Those findings prompted Public Citizen to  file a petition with the FDA asking that Avandia be removed from the market.

Just this past July, Public Citizen published a new study linking Avandia to death resulting from liver failure in the peer-reviewed medical journal Pharmacoepidemiology and Drug Safety.  The study discussed 11 cases of severe liver toxicity, mostly fatal, that were associated with Avandia use.  According to a Public Citizen press release, the cases were identified after careful analysis of MedWatch forms submitted between 1997 and 2006 to the FDA’s Adverse Event Reporting System (AERS). These forms are submitted to the agency by patients and health-care providers when adverse drug reactions are suspected.

According to Public Citizen, Avandia also doubles the risk of heart failure and bone fractures, and increases the risk of anemia and vision loss from macular edema, a swelling of the retina caused by fluids accumulating in the eye. There were 39 times more reports of macular edema per million prescriptions filled for Avandia than for an older diabetes drug, glipizide, the group said.

"The research is yet another indication that Avandia is too dangerous to remain on the market," said Dr. Sidney Wolfe, acting president of Public Citizen, director of Public Citizen’s Health Research Group and co-author of the study. "The FDA’s new leadership should demonstrate its commitment to public health by banning this drug, thereby preventing needless deaths and serious adverse events."

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