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Bayer revises contraceptives labels to reflect clotting risk

Information for Yaz, Beyaz, Safyral and Yasmin updated following risk-evaluating studies

Bayer has added specific wording to the labels of oral contraceptives containing drospirenone warning of an increased risk of blood clots.

The company said the updated labels include information from recent studies evaluating the risk of venous thromboembolism (VTE) in drospirenone-containing contraceptives, including its Yaz, Beyaz, Safyral and Yasmin products which collectively brought in 1.07bn euros ($1.4bn) in sales last year.

The studies indicated that drospirenone was up to three times more likely to cause VTE than other progestins such as levonorgestrel.

Changes to the labelling were expected given that an FDA advisory committee voted last December to support continued use of the products and generic equivalents, saying that the benefits of having plenty of contraceptive choices on the market outweighed the small increase in risk.

Generic contraceptive products which contain drospirenone and will also be affected by the label changes include Ocella (Barr), Loryna (Sandoz), Gianvi (Teva), Syeda (Sandoz) and Zarah (Watson).

The FDA said yesterday it had completed its safety review and concluded that there was an increase in risk, although the studies "did not provide consistent estimates of the comparative risk of blood clots between birth control pills that contain drospirenone and those that do not".

Placing the warning in perspective, the agency added: "The risk of blood clots is higher when using any birth control pills than not using them, but still remains lower than the risk of developing blood clots in pregnancy and in the postpartum period."

Women should talk to their healthcare professional about their risk for blood clots before deciding which birth control method to use, according to the agency, and healthcare professionals should consider the risks and benefits of drospirenone-containing birth control pills - and a woman's risk for developing a blood clot - before prescribing these drugs.

The European Medicines Agency (EMA) said in May 2011 that it had updated product information on oral contraceptives containing drospirenone in light of new 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.

11th April 2012

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