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FDA Drug Safety Podcast for Healthcare Professionals: Safety review update on the 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 September 26, 2011, the Food and Drug Administration issued a Drug Safety Communication informing the public that it has not yet reached a conclusion, but remains concerned, about the potential increased risk of blood clots with the use of drospirenone-containing birth control pills. FDA has completed its review of the two 2011 studies that evaluated the risk of blood clots for women who use drospirenone-containing birth control pills, previously mentioned in FDA's Drug Safety Communication issued on May 31, 2011.  FDA is continuing its review of a separate FDA-funded study that evaluated the risk of blood clots in users of several different hormonal birth control products, or contraceptives. Preliminary results of the FDA-funded study suggest an 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. 

Given the conflicting nature of the findings from six published studies evaluating this risk, as well as the preliminary data from the FDA-funded study, FDA has scheduled 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. 

Women currently taking a drospirenone-containing birth control pill should be informed of the potential risk for blood clots. 

FDA will continue to communicate any new information to the public as it becomes available. 

At this time, FDA recommends that Healthcare Professionals be aware that: 

  1. The risks and benefits of drospirenone-containing combination oral contraceptives should be considered for a specific patient in light of her risk for developing blood clots (i.e. venous thromboembolism, or VTE) before prescribing a drospirenone-containing oral contraceptive.
  2. Patients should be counseled about the current information regarding the risk of VTE with drospirenone-containing oral contraceptives compared to levonorgestrel-containing oral contraceptives.
  3. Factors for increased risk of VTE in users of birth control pills include smoking, obesity, and family history of VTE, in addition to other factors that contraindicate use of combination oral contraceptives.
  4. The studies assessing the risk of blood clots have evaluated only the specific drospirenone-containing product that combines 3 mg of drospirenone with 0.03 mg of ethinyl estradiol. It is not known whether these study results apply to other drospirenone-containing products with a lower dose of estrogen (e.g., 0.02 mg ethinyl estradiol).
  5. Adverse events involving oral contraceptives should be reported 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 the complete Data Summary detailing this communication. A link to this DSC including a list of the approved oral contraceptives containing drospirenone 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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