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FDA Review of Yaz, Yasmin Blood Clot Risk Inconclusive, But Concerning

Sep 27, 2011 | Parker Waichman LLP

The U.S. Food & Drug Administration (FDA) announced yesterday that has not yet reached a conclusion, but remains concerned, about the blood clot risk that may be posed by birth controls like Yaz and Yasmin that contain drospirenone.  According to a Drug Safety Communication posted Monday on its website,  studies the FDA reviewed reached conflicting conclusion, but several, including one funded by the FDA, did see an increased risk of blood clots among women who take oral contraceptives made with drospirenone.

Yaz, Yasmin and other drospirenone-containing birth control pills have become popular because some women tolerate this type of progestin better, and some side effects, like water retention, are less severe compared to other pills. But drospirenone is known to carry other risks. For one thing, it can impact the body’s potassium levels, which can cause a condition known as hyperkalemia, and lead to serious health complication.

The FDA decided to review the safety of drospirenone contraceptives after two British Medical Journal studies reported that those made with drospirenone increased those risks significantly compared to pills made with levonorgestrel.   In addition to the two British Medical Journal studies, the agency also reviewed preliminary results from a study it funded which showed n approximately 1.5-fold increase in the risk of blood clots for women who use drospirenone-containing birth control pills compared to users of other hormonal contraceptives.   That study involves 80,000 women taking several different hormonal contraceptive products.

Two other studies required by the FDA or European regulatory agencies that not report any difference in blood clot risk between drospirenone-containing products and products containing levonorgestrel or other progestins, the FDA said.

The FDA did note  that the available studies have only examined the risk of blood clots in users of contraceptive pills that contain drospirenone and 0.03 mg of ethinyl estradiol (an estrogen) and not other pills that contain drospirenone combined with a lower dose of estrogen (e.g., 0.02 mg ethinyl estradiol). It is unknown at this time whether the reported an increased blood clot risk applies to all drospirenone-containing products, the agency said.

Given the conflicting results of its review, the FDA has decided to  schedule a joint meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on December 8, 2011 to discuss the risks and benefits and specifically the risk of blood clots of drospirenone-containing birth control pills. 

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