The bad news for Avandia continues. The FDA announced today that it will significantly restrict the use of the diabetes drug Avandia (rosiglitazone) to patients with Type 2 diabetes who cannot control the disease with Actos (pioglitazone) or other medications. These new restrictions are in response to data that suggest an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia. This is an interesting announcement given that Actos is currently under review for a potential link to bladder cancer (no definitive link has been made as of yet).

In July, after an intensive two-day hearing regarding the conflicting data surrounding Avandia, a FDA advisory panel voted in late July to keep the drug on the market with the addition of warnings and stricter product labeling. See previous blog coverage of Avandia for more background.

UPDATE: European regulators have announced that Avandia's approval will be withdrawn.

 
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