NeLM news service
FDA to consider stronger warnings on drug labels for drospirenone containing contraceptives

Source: Reuters Health News

Date published: 08/12/2011 17:39

Summary
by: Yuet Wan

According to a Reuters report, the FDA is considering stricter labelling on the new generation of oral contraceptives that contain drospirenone (e.g. Yaz and Yasmin) based on data showing a link to a higher risk of thrombosis. The report noted that the body of evidence shows conflicting data but the link with thrombosis could not be totally ruled out and may actually warrant a new drug label. A panel of external experts advising the Agency is due to vote on the labels next week.

 

Earlier in the year, the FDA had released the final report of its study evaluating the risk of thrombosis in users of several different hormonal contraceptives- see link below for further details.

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