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FDA Drug Safety Podcast for Healthcare Professionals: Safety Review of possible increased risk of blood clots with birth control pills containing drospirenone

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Welcome, my name is Jennifer Shepherd, a pharmacist in the Division of Drug Information.  On May 31, 2011, the Food and Drug Administration issued a Drug Safety Communication informing the public about new information that is being assessed as part of FDA's ongoing safety review of birth control pills that contain drospirenone. This review will further evaluate the risk of blood clots in women who use these products. 

Drospirenone is a type of female sex hormone called a progestin. Most birth control pills contain two types of hormones--estrogen and progestin. Birth control pills work by preventing ovulation and changing the cervical mucus and the lining of the uterus to prevent pregnancy.

All birth control pills pose a risk of blood clots. Several epidemiological studies have reported that the risk of blood clots for women who use birth control pills containing drospirenone is higher than that for women who use birth control pills containing the progestin levonorgestrel. Other studies have not reported an increase in risk.

A blood clot that forms in a deep vein in the body is called a deep vein thrombosis or DVT. A DVT is a rare side effect of taking birth control pills. A blood clot can break loose from the vein, move through the body to the lung, and cause a serious problem in the lung, called a pulmonary embolism, or PE. This can lead to death.

Two recently published studies reported a greater risk of blood clots for women taking birth controls containing drospirenone as compared to the risk in women taking birth control pills containing another progestin known as levonorgestrel.

Previously published studies have also addressed the risk of blood clots in women using birth control pills containing drospirenone. These studies had conflicting findings--two postmarketing studies required by the FDA or European regulatory agencies did not report any difference in the risk of blood clots between drospirenone-containing products and products containing levonorgestrel or other progestins. Two other publications in 2009, however, reported that the risk of blood clots is higher in women using drospirenone-containing products than in women who use levonorgestrel-containing products.

Information from these latter four studies is already presented in the Warnings and Precautions section of current labels for drospirenone-containing birth control pills. An additional large study exploring the association of blood clots with hormonal contraception has been commissioned by FDA, and results of that study are currently being finalized and reviewed.

The European Medicines Agency announced on May 27, 2011, that it is updating the product information on oral contraceptives containing drospirenone and ethinyl estradiol regarding the risk of venous thromboembolism after review of all available data, including the same newly published data FDA is reviewing. 

The FDA is currently evaluating the conflicting results from these studies and will look at all currently available information to fully assess the risks and benefits of drospirenone-containing birth control pills. FDA will continue to communicate any new safety information to the public as it becomes available.

At this time, FDA recommends that Healthcare Professionals:

  1. Continue to follow the recommendations in the drug labels when prescribing oral contraceptive products that contain drospirenone.
  2. Discuss the known benefits and potential risks of drospirenone-containing products with your patients.
  3. Educate your patients to recognize the signs and symptoms of DVT and PE, and tell them to immediately contact their healthcare professional if they develop any of these symptoms.
  4. Report adverse events involving drospirenone-containing oral contraceptives to the FDA MedWatch program at www.fda.gov/medwatch.

Thank you for listening. The FDA is committed to keeping healthcare professionals informed of the latest safety information.  Please read the Drug Safety Communication for a list of drospirenone-containing birth control pills and background information detailing this communication.  A link to this DSC can be found at www.fda.gov/Drugs/DrugSafety.   If you have drug questions, you can reach us at druginfo@fda.hhs.gov.

 

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