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FDA panel backs Bayer's Yaz/Yasmin; warns over blood clots

Advisory committee recommends label change for oral contraceptive to indicate increased risk of blood clots, but benefits still outweigh risks

A US Food and Drug Administration (FDA) advisory committee has recommended changing the labelling for Bayer's big-selling Yaz and Yasmin oral contraceptives and generic equivalents to indicate they can increase the risk of blood clots.

The panel voted by 15-11 to endorse continued use of the products, however, saying that the benefits outweighed the small increase in risk. Supporters indicated that it was desirable to have plenty of contraceptive choices available on the market.

Both Yaz and Yasmin contain the progestin component drospirenone, and the FDA ordered an investigation into their safety after data suggested they may be more likely to cause venous thromboembolism (VTE) than contraceptives based on the older progestin levonorgestrel.

Studies reported in the British Medical Journal earlier this year indicated that women taking Yasmin were two- to three-times more likely to develop non-fatal blood clots than those on levonorgestrel-based contraceptives. Meanwhile, an FDA meta-analysis of various studies suggested that women taking drospirenone were 74 per cent more likely to experience blood clots than those on older contraceptives.

After reviewing the data, the panel voted by 21 to 5 that the current US labels do not adequately reflect the benefit-risk profile for these products and should be revised to include information from studies assessing the risk for VTE.

Yaz and related drospirenone-based medicines Yasmin and Yasminelle is a big-earning franchise for Bayer. The products pulled in €780m in the first nine months of 2011 - albeit down around 4 per cent from the same period of 2010 because of negative publicity about the VTE risk and generic competition - and it remains the pharma company's second-biggest product.

Other brands which contain drospirenone include Beyaz (Bayer), Ocella (Barr), Loryna (Sandoz), Gianvi (Teva), Safyral (Bayer), Syeda (Sandoz) and Zarah (Watson).

The FDA panel verdict follows an announcement by the European Medicines Agency (EMA) in May that it will update product information on oral contraceptives containing drospirenone in light of the information on VTE risk.

Bayer is currently facing more than 10,000 lawsuits in the US alleging injury caused by use of Yaz or Yasmin oral contraceptives or authorised generic equivalents.

12th December 2011

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