FDA Panel Recommends Warnings, Tighter Restrictions for Avandia®

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After two days of contentious discussion, a federal advisory committee voted to recommend that the controversial diabetes drug Avandia remain on the market — but with tighter supervision and warnings about the danger of heart attacks.

*** Avandia® Labeling Update 2/4/11: The FDA has notified healthcare professionals and patients that information on the cardiovascular risks (including heart attack) of Avandia (rosiglitazone) has been added to the physician labeling and patient Medication Guide. Additionally, the drug labels have been revised to state that rosiglitazone and rosiglitazone-containing medicines should only be used:

  • In patients already being treated with these medicines
  • In patients whose blood sugar cannot be controlled with other anti-diabetic medicines and who, after consulting with their healthcare professional, do not wish to use pioglitazone-containing medicines (Actos, Actoplus Met, Actoplus Met XR, or Duetact).

Free Avandia Case Evaluation: If you or a loved one has suffered a heart attack, stroke, or other serious side effect after taking Avandia, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.

What’s the problem?

July 15, 2010 – This week, a 33-member FDA panel took six votes on a variety of issues, but its most important came near the end of the meeting when asked what the administration should do about Avandia.

Of the panel’s members, 12 voted that Avandia should be withdrawn; 10 voted that its sales should be restricted and the warnings on its label enhanced; seven voted only to support enhanced warnings on the drug’s label; and three voted that the drug should continue to be sold with its present warnings unchanged.

Several panelists blasted GlaxoSmithKline (GSK) for not conducting better safety trials of its drug, forcing experts to grapple with uncertainty for two days. Many panelists said they did not trust the results of the company’s main study defending the drug and expressed contempt at the way the company analyzed its studies.

Experts had expected the 33-member panel to recommend removing the drug altogether, based on evidence that Avandia, prescribed to control blood sugar in patients with Type 2 diabetes, increases risk of heart attack. That is a particularly worrisome side effect in this population, considering that diabetes itself raises the risk of heart disease.

At the peak of its popularity in 2006, 13 million prescriptions were written, according to IMS Health, a pharmaceutical market research company. By 2009, the number had declined to about 2.6 million. Still, GSK said some 550,000 Americans took medications containing Avandia in the past year.

Do I have an Avandia Lawsuit?

The Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus exclusively on the representation of plaintiffs in Avandia lawsuits. We are handling individual litigation nationwide and currently accepting new cases in all 50 states.

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