Posted: 07-14-10 Categories:
Avandia FDA
Avandia News
Avandia Recall

FDA Panel Vote NO AVANDIA RECALL, Revise Warning, Restrict Use

On July 14, 2010, the joint FDA drug advisory panel on Avandia safety voted NOT to recall Avandia. GlaxoSmithKline’s controversial Type 2 Diabetes medicine has come under increasing criticism as Avandia safety studies link Avandia use to a higher risk of heart attack, stroke and congestive heart failure compared to other medications.

How did the 33 members of the FDA advisory committee vote when asked what regulatory action should be taken on Avandia by the U.S. Food and Drug Administration? Here are the number of votes received for each of the options:

0 Votes A. Allow continued marketing and revise the current label to remove the boxed warning and other warnings regarding an increased risk of ischemic CV events, or

3 Votes B. Allow continued marketing and make no changes to the current label, or

7 Votes C. Allow continued marketing and revise the current label to add additional warnings (e.g., contraindications for certain patient populations, recommendation for second-line use in patients intolerant of or uncontrolled on other anti-diabetic agents); or

10 Votes D. Allow continued marketing, revise the current label to add additional warnings, and add additional restrictions on use (such as restricting prescribing to certain physicians or requiring special physician and patient education)

12 Votes E. Withdrawal from the U.S. market.

1 Abstention

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