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FDA assesses evidence for risk of Thrombosis with drospirenone-containing drugs

Read time: 1 mins
Last updated:7th Dec 2011
Published:7th Dec 2011
Source: Pharmawand
As part of its ongoing review, the FDA reports that evidence shows conflicting data on a link between pills containing drospirenone (such as Safyral from Bayer) and blood clots, some of which appears to show a slight elevation of venous thromboembolism risk. Since the FDA reports it can not rule out the risk, it suggests this may warrant a new label for medicine containing the drug. A panel of consultants advising the FDA will vote on potential label changes. The two Committees considering the evidence are the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee.

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