NeLM news service
US FDA urged to re-evaluate risks/benefits of drospirenone-containing oral contraceptive

Source: Reuters Health News

Date published: 16/01/2012 16:39

Summary
by: Hina Radia

The US Food and Drug Administration (FDA) has been urged to reconsider the safety of drospirenone containing oral contraceptive pills (Yas/Yasmin) after some advisers who had originally voted to keep the products on the market were reported to have links to the manufacturers of the products.

 

The panel had previously decided by a four-vote margin that the benefit of pregnancy prevention from these pills outweighed their risk of venous thromboembolism. But according to court and public documents, three of the FDA's 26 advisers had research or financial ties to Bayer, and a fourth adviser had a connection to a manufacturer of generic copies of Yaz, Barr Laboratories, now part of Teva Pharmaceuticals.

 

[The MHRA had previously issued a Drug Safety Update highlighting the risk of venous thromboembolism associated with Yasmin – please see link below for MHRA advice]

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