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Drospirenone birth control (Yaz, others) to be topic of FDA special meeting Dec. 8 examining deep-vein thrombosis risks

(Oct. 11, 2011) – The U.S. Food & Drug Administration plans to convene a joint meeting of two advisory committees Dec. 8 to explore whether Yaz, Yasmine and all other birth-control pills containing drospirenone pose enough risk of causing blood clots and deep-vein thrombosis to warrant some sort of federal action.

The FDA cites conflicting findings from six published studies evaluating this risk – plus preliminary data from its own investigation, which suggest an approximately 1.5-fold increase in the risk of blood clots for women who use drospirenone birth-control pills (compared to users of other hormonal contraceptives) – as reasons for calling the meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and the Risk Management Advisory Committee.

No conclusion about what these various studies reveal has yet been drawn by the FDA, although the regulatory agency earlier took the step of recommending physicians exercise caution when prescribing this type of birth-control pill and that they discuss with users the signs and symptoms of deep-vein thrombosis and pulmonary embolism.

Australia, Euro Union advise physicians

Australia, too, has issued a recommendation to physicians through its national Therapeutic Goods Administration (that nation’s equivalent of the FDA). Per the TGA, “health professionals should weigh the clinical needs of patients against the possible risk, and educate patients to recognise the signs and symptoms of venous thromboembolism.”

The TGA also encouraged physicians to report adverse events associated with all oral contraceptives, and reminded them that such drugs are contraindicated in women 35 and older who smoke or who sit for very long periods – both considered serious risk factors for venous or arterial thrombosis.

Meanwhile, the European Medicines Agency (EMA), another FDA counterpart, announced in May that product information for birth-control pills with drospirenone and ethinyl estradiol will be updated once health officials there finish reviewing much the same data currently under FDA examination.

Up to three-fold greater risk

Concerns about deep-vein thrombosis and pulmonary embolism reached the current heightened state following the publication of the two most recent studies, published in the online April edition of British Medical Journal [BME].

These studies showed as much as a three-fold greater risk for pulmonary embolism and deep-vein thrombosis in women taking drospirenone birth-control pills.

A third study of importance is the one funded by the FDA. In that investigation, more than 800,000 women participated.

Drospirenone is classified as a progestin. Brand-name contraceptives using drospirenone include Yaz, Yasmine, Beyaz, Gianvi, Loryna, Ocella, Safyral, Syeda and Zarah.

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