FDA schedules review of drospirenone pills

The Food and Drug Administration (FDA) has scheduled a Dec. 8, 2011, meeting of its Reproductive Health Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee to review the risks and benefits of oral contraceptives containing the progestin drospirenone. The agency is weighing evidence regarding the risk of increased blood clots in users of such pills.

The federal regulatory agency 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.1,2 It is continuing to analyze a separate FDA-funded study that evaluated the risk of blood clots in users of several hormonal 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.3 

Although advisory committees provide recommendations to the agency, the FDA makes the final decisions regarding drug use, says Lisa Kubaska, PharmD , a spokesperson for the agency's Center for Drug Evaluation and Research. The agency posts transcripts of public advisory committee meetings 2-4 weeks after the conclusion of a meeting. (They may be accessed by visiting the FDA web site, www.fda.gov. Under "About FDA" on the lower left side of the page, select "Advisory Committees," then under the "Advisory Committees" heading, select "Drugs," then "Reproductive Health Drugs Advisory Committee." Click on "2011 Meeting Materials" to see material related to each committee meeting.)

What to keep in mind?

Drospirenone is the progestin contained in the Yaz/Yasmin line of oral contraceptives from Bayer HealthCare Pharmaceuticals of Wayne, NJ. The progestin also is found in generic equivalents: North Wales, PA-based Teva Pharmaceuticals' Ocella and Gianvi; Princeton, NJ-based Sandoz's Loryna and Syeda; and Morristown, NJ-based Watson Pharmaceuticals' Zarah. In 2010, Bayer received FDA approval for two drospirenone pills with added folate: Beyaz and Safyral. Beyaz contains 20 mcg of ethinyl estradiol, while Safyral contains 30 mcg of ethinyl estradiol; both pills contain 3 mg of drospirenone.

Until the FDA issues further communication, what should clinicians keep in mind regarding drospirenone pills? The agency lists five points:

  • The risks and benefits of drospirenone-containing pills should be considered for a specific patient in light of her risk for developing blood clots before prescribing such a pill.
  • Counsel patients about the current information regarding risk of venous thromboembolism (VTE) with drospirenone-containing oral contraceptives compared to levonorgestrel-containing oral contraceptives.
  • 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.
  • The studies that have looked at 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, the FDA notes.
  • Clinicians should report adverse events involving oral contraceptives to the FDA MedWatch program at www.fda.gov/medwatch.

What should women do?

What should women do if they are taking birth control pills containing drospirenone? The FDA advises that these women should continue taking their pills as directed unless told otherwise by their healthcare professional. 

Staying the course on pills is an important message, according to Anita Nelson, MD, professor in the Obstetrics and Gynecology Department at the David Geffen School of Medicine at the University of California in Los Angeles. All pills are safer than pregnancy, she notes.

Teach women to recognize the symptoms of blood clots, including persistent leg pain, severe chest pain, or sudden shortness of breath. Advise them to contact your office immediately if they develop any of these symptoms.

Explain to women that the risk of VTE also increases with age and is higher in women who smoke, are overweight, or have a family history of blood clots. Women with a history of blood clots, heart attack, or stroke should not take any type combination birth control pills. Because drospirenone, in contrast to other progestins used in combination oral contraceptives, has the potential to increase serum potassium levels, women with kidney or adrenal disease should not use birth control pills containing drospirenone.4 

References

  1. Jick SS, Hernandez RK. Risk of non-fatal venous thromboembolism in women using oral contraceptives containing drospirenone compared with women using oral contraceptives containing levonorgestrel: case-control study using United States claims data. BMJ 2011. Doi: 10.1136/bmj.d2151.
  2. Parkin L, Sharples K, Hernandez RK, et al. Risk of venous thromboembolism in users of oral contraceptives containing drospirenone or levonorgestrel: nested case-control study based on UK General Practice Research Database. BMJ 2011. Doi: 10.1136/bmj.d2139.
  3. Food and Drug Administration. FDA drug safety communication: safety review update on the possible increased risk of blood clots with birth control pills containing drospirenone. Accessed at http://www.fda.gov/Drugs/DrugSafety/ucm273021.htm.
  4. Food and Drug Administration. Questions and answers - safety review update on the possible increased risk of blood clots with birth control pills containing drospirenone. Accessed at: http://www.fda.gov/Drugs/DrugSafety/ucm273021.htm.