Controversy Rages Over Diabetes Drug's Heart Risks

FDA official says superiors ordered her to back off serious warning
By Mary Papenfuss,  Newser Staff
Posted Jun 6, 2007 12:16 PM CDT
Controversy Rages Over Diabetes Drug's Heart Risks
'   (Getty Images)

(Newser) – Troubling questions about the diabetes drug Avandia persisted yesterday as an FDA official revealed that she was barred from recommending a critical warning about the medication, the Times reports. In the run-up to congressional hearings that began today, manufacturer GlaxoSmithKline rushed to disseminate interim clinical findings in hopes of blunting the controversy.

A recent study determined that Avandia could increase heart attack risk by 43%: GSKs own trials found fewer heart deaths among users than a control group. The FDA is drawing fire for not making the drug's cardiovascular risks clearer, and the official who was ordered to drop a recommendation for a "black box" warning said she was punished for raising concerns. (Read more Avandia stories.)

We use cookies. By Clicking "OK" or any content on this site, you agree to allow cookies to be placed. Read more in our privacy policy.
Get the news faster.
Tap to install our app.
X
Install the Newser News app
in two easy steps:
1. Tap in your navigation bar.
2. Tap to Add to Home Screen.

X