Mixed views on drospirenone OCs

The majority of members of the US Food and Drug Administration’s Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted (15 to 11) that the benefits of drospirenone-containing combination oral contraceptives (COCs) in the prevention of pregnancy outweigh the potential risks.

However, the panelists also voted (21 to five) that the current labels for Germany-headquartered Bayer’s (BAY: DE) drospirenone-containing combination oral contraceptives - Yaz and Yasmin (drospirenone/ethinylestradiol) - do not adequately reflect the risk benefit profile for these products and should be revised to include additional information from available studies.

Panelists discussed often conflicting data on the blood clot risk of drospirenone-containing drugs compared with older medications. While the group disagreed on the quality of the evidence, the overwhelming majority said it should be clearly stated in the label, including the potentially fatal nature of blood clots. "Clearly the wording is inadequate and incomplete," said Richard Bockman of New York's Hospital for Special Surgery, quoted by the Sacramento Bee, adding: "Adverse events have to be made graphic so physicians and patients are aware of the consequences."