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New Warning Label on Drospirenone-Containing Birth Control Pills
by Leigh Ann Woodruff, April 11, 2012
Birth control pills containing drospirenone will carry a new warning label about the risk of blood clots. The new labels state that combination oral contraceptives containing drospirenone may be associated with a higher risk of venous thromboembolism (VTE) than oral contraceptives containing levonorgestrel or some other progestins.
The birth control pills affected include brand names Yaz, Yasmin, Beyaz and Safyral.
Drospirenone is a synthetic form of progestin and is known to increase potassium levels in the blood. "The revised drug labels will report that some epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products when compared to products containing levonorgestrel or some other progestins, whereas other epidemiological studies found no additional risk of blood clots with drospirenone-containing products," according to a statement issued by the Food and Drug Administration.
To put the risk in perspective, the FDA says: "The risk of blood clots is higher when using any birth control pills than not using them, but still remains lower than the risk of developing blood clots in pregnancy and in the postpartum period."
Oral contraceptives containing drospirenone are used for birth control, but they may also be used to regulate cycles for in vitro fertilization (IVF) or in the treatment of polycystic ovarian syndrome (PCOS), premenstrual dysphoric disorder (PMDD) and moderate acne.
An FDA-funded study compared medical records of women taking Yaz with those taking an older birth control pill containing the hormone called levonorgestrel and found that women taking pills containing the hormone drospirenone were 74 percent more likely to experience clots than those on low-estrogen pills. In December 2011, an advisory committee of outside experts to the FDA voted to revise the label for pills with drospirenone and called for clearer information about their risks and benefits.
A deep vein thrombosis is an event in which a blood clot forms inside a vein. A clot in the vein can be fatal if it breaks loose and travels to the heart, lung or brain. If you are experiencing any of the following symptoms, seek the help of a health care professional immediately:
- the new onset of persistent leg pain
- severe chest pain
- sudden shortness of breath
If you have negative side effects from your birth control pills or any prescription drugs, report them to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.