The US Food and Drug Administration (FDA) has said that it remains concerned about the risk of blood clots with the use of drospirenone-containing birth control pills, including those made by German drug company Bayer.
In a safety announcement on Monday, the agency said that preliminary results of a study that it funded, involving 800,000 women, suggested an approximately 1.5-fold increase in the risk of blood clots for women who use the drospirenone-containing pills compared with users of other hormonal contraceptives.
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Bayer’s best selling birth control drugs, including Yaz and Yasmin, contain the compound.
The FDA has scheduled a joint meeting with the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on 8 December to discuss the risks and benefits of the pills.
The agency has completed its review of two studies evaluating the risk of blood clots in women, but has not reached a conclusion yet.
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By GlobalData
