Birth Control Pills’ containing Drospirenone Label Change due to Potential Higher Risk for Blood Clots

FDA warns OB/GYN, Family Practice professionals and patients that the labels of birth control pills containing drospirenone will include information on their potential association with a higher risk for blood clots than other progestin-containing pills.

Background of Birth Control Pills containing Drospirenone

Drospirenone is part of some birth control pills and hormone replacement therapy.

It is a synthetic version of progesterone or progestin.

FDA Alert on Birth Control Pills containing Drospirenone

The completion of the FDA’s review of recent epidemiologic studies concerning the risk of blood clots in women taking drospirenone-containing birth control pills revealed that these pills may be associated with a higher risk for blood clots than other progestin-containing pills.

The revised labels will include the information that, according to some studies, there is a three-fold increase in the risk of blood clots for drospirenone-containing products when compared to pills containing other progestins.

Recommendation on Birth Control Pills containing Drospirenone

“Women should talk to their healthcare professional about their risk for blood clots before deciding which birth control method to use.

Healthcare professionals should consider the risks and benefits of drospirenone-containing birth control pills and a woman’s risk for developing a blood clot before prescribing these drugs.”

Contacting the FDA to report cases with Birth Control Pills containing Drospirenone

In case of detection of adverse events or side effects related to the use of Birth Control Pills containing Drospirenone, healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

The report can be completed and submitted online at: www.fda.gov/MedWatch/report.htm

The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form

The completed form can be faxed to:  1-800-FDA-0178

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