New Avandia Label Addresses Heart Attack Risk

The AP reports that the maker of Avandia, GlaxoSmithKline PLC, has announced they have updated the diabetes pill labeling to “include safety restrictions ordered by federal health authorities because of the drug's links to heart attack.” The AP explains that these changes come in response to “thousands of patient lawsuits and a Department of Justice investigation.”

The article explains these safety precautions come after “The Food and Drug Administration announced the changes in September as the last in a series of safety actions against the former blockbuster drug.” According to the report, this “new U.S. label indicates that Avandia is only intended for patients who cannot control their blood sugar with any of the other diabetes medications on the market.”

Patients currently taking the drug are encouraged to consult with their doctors before continuing to take the medication, the article explains. However, the AP reports that the European Union has completely banned the use of the medication.  

According to the AP, “The FDA first approved Avandia in 1999 and it became the top-selling diabetes pill in the world, with more than $3 billion in sales by 2006.” However, the AP explains that since indications of its link to heart attack surfaced in 2007, U.S. use of the diabetes medication has dropped significantly.

The AP goes on to explain that despite the presence of “more than a dozen diabetes drugs on the market, only Actos from Japan-based Takeda Pharmaceuticals works the same way as Avandia.” According to the report, that drug’s popularity has “risen steadily - hitting $3.4 billion in 2009 - as Avandia's reputation has soured.”  

Avandia’s history began in 1999 when the FDA approved the drug, making it “the top-selling diabetes pill in the world, with more than $3 billion in sales by 2006,” the AP reports. However, the 2007 analysis linking the medication to increased risk of patient heart attack has reversed that initial popularity, the AP explains.

“Determining Avandia's heart risk was a painstaking process that dragged on for years because most patients taking the drug are already predisposed to heart problems due to diabetes,” the AP says, accounting for the recent delay in regulation.   

Although over “900,000 U.S. patients filled prescriptions for Avandia in the first half of 2010,” the implementation of these FDA restrictions is expected to shrink that number, the AP explains. Even worse for Glaxo, the AP reports, last year the company said “that the Justice Department and several state attorneys general” were investigating both the development and marketing of this medication. Furthermore, the article goes on to explain that “A Senate investigation released last year concluded that Glaxo knew about the risks of its drug years before they were made public and withheld important data from the FDA.”

To date, Glaxo has already “settled thousands of personal injury lawsuits filed by Avandia patients, though Glaxo executives say a number of additional lawsuits have been filed since the FDA's announcement last year,” the AP reports.    

References:

Perrone, Matthew. (February 7, 2011) “Glaxo adds safety restrictions to Avandia label.” Retrieved on February 8, 2011 from The Associated Press.