FDA Issues Strictest Warning on Prescription Diabetes Drug Avandia

On June 6, 2007, the Food and Drug Administration (FDA) called for the most stringent warning to be added to prescription Type 2 diabetes drug Avandia.

The decision was revealed before a packed Congressional House hearing. It comes, however, more than a year after FDA safety reviewers strongly recommended that the agency take such a step.

In effect, the decision tells GlaxoSmithKline, manufacturer of Avandia, to make the warning about Avandia's heart risks more prominent, by placing it in a so-called "black box."

According to the New York Times, the call for this heightened warning is due to the fact that "despite existing warnings, these drugs [[diabetes drugs Avandia and Actos, the latter made by Eli Lilly]] were being prescribed to patients with significant heart failure."

The article quotes Representative Henry Waxman, a California Democrat who is chairman of the House Committee on Oversight and Government Reform as saying, "Avandia is a case study of the need for reform of our drug safety laws."

If you or a loved one has suffered cardiac complications after ingesting Avandia, you deserve the guidance of an experienced drug attorney. Get a free case review by filling out the form below.

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Black Box Warning

FDA: Manufacturer of Avandia Strengthens Warning on Heart Failure Risk
FDA Says GlaxoSmithKline Will Include Boxed Warning on Avandia Label

FDA Warning, 5.22.07

FDA Alert on the Anti-Diabetes Drug Avandia: Risk of Heart Attack
Risks to taking the drug Avandia include heart attack and chest pain

Scientists Silenced

Scientists Silenced About the Dangers of Avandia--Attorney Resources
Editorial: Scientists Silenced About Avandia--Get an Avandia Attorney

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