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FDA Announces Yaz Label Change to Reflect Blood Clot Risk

The FDA called for updated labels on birth control pills like Yaz and Yasmin to include the potential increased risk of blood clots. According to the FDA, some studies have shown that women who take oral contraceptives containing the synthetic hormone drospirenone, including Yaz and Yasmin, may have a two- to three-times increased risk of …

The FDA called for updated labels on birth control pills like Yaz and Yasmin to include the potential increased risk of blood clots. According to the FDA, some studies have shown that women who take oral contraceptives containing the synthetic hormone drospirenone, including Yaz and Yasmin, may have a two- to three-times increased risk of developing dangerous blood clots. The FDA’s decision to change the drug labels comes after a panel of experts determined that birth control pills containing drospirenone should have stronger warnings in December, voting 21-5 that the labels in place fail to adequately reflect the benefits and risks of the products.

Safety of Yaz and Yasmin Questioned in Light of Blood Clot Risk

Yaz and Yasmin belong to a class of oral contraceptive called fourth-generation combination drugs, meaning they contain the newer synthetic progestin called drospirenone. Despite the fact that these birth control pills are marketed on the basis that they offer better relief from acne, premenstrual symptoms and weight gain than other birth control pills, the potential link between the drugs and blood clots has raised serious concerns about the safety of Yaz and Yasmin. Yasmin was approved by the FDA in 2001 and was the first oral contraceptive to use drospirenone. Yaz followed in 2006 and quickly became one of the best-selling birth control pills on the market. Yaz currently brings in $1.56 billion in global sales for drug firm Bayer.

Pills May Increase Risk of Blood Clots by Two to Three Times

Although the FDA issued previous warnings concerning the risk of blood clots in patients using drospirenone products on May 31, 2011, September 26, 2011 and October 27, 2011, the agency has noted that not all studies have established a clear connection between drospirenone-containing oral contraceptives and blood clots. “The revised drug labels will report that some epidemiological studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products […] whereas other epidemiological studies found no additional risk,” said the FDA. However, some studies, including two published recently in the British Medical Journal, have indicated an increased risk of blood clots (as high as two- to three-fold) associated with these products, compared to earlier generation pills.

In light of this blood clot risk, the FDA has recommended that healthcare professionals consider the risks and benefits of drospirenone-containing oral contraceptives and a woman’s risk for developing a blood clot before prescribing these drugs. Blood clots are extremely dangerous and can result in life-threatening complications like heart attack or stroke if they break off and travel to the lungs, heart or brain.

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