Avandia gets FDA win, but is unlikely to dominate market again
A Food and Drug Administration advisory panel has voted to ease measures that limit patient access to the diabetes pill Avandia. Many panelists, however, said precautions are still needed.
In 2010, around 250,000 people were taking Avandia in the United States, a number that has dropped to 3,000, the Associated Press reported. That's due in large part because the drug was found to raise the risk of a heart attack and the FDA subsequently restricted its access. Now, Avandia can be given only by specific pharmacies. Physicians also must sign a waiver saying they understand the risks.
The panel now recommends to the FDA that patients be required to sign a waiver if they want to receive it.
GlaxoSmithKline agreed to pay a $90 million settlement to 38 states last year following allegations it did not properly report safety data on the drug. Even if the FDA follows the panel's advice, sources told the AP that Avandia is unlikely to re-emerge as a major treatment for diabetes.