FDA issues new labeling for drospirenone pills

Look for new labeling on combined oral contraceptives (OCs) containing drospirenone following the Food and Drug Administration's (FDA) review of studies regarding the risk of blood clots in women using such formulations. Based on its review, the FDA has concluded that drospirenone-containing oral contraceptives might be associated with a higher risk for blood clots than other progestin-containing pills.

Drospirenone is the progestin contained in the Yaz/Yasmin line of oral contraceptives from Bayer HealthCare Pharmaceuticals of Wayne, NJ. Two other Bayer products also contain drospirenone: Beyaz and Safyral. Drospirenone 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. Watson received FDA approval in November 2011 for Vestura, a generic equivalent to Yaz.

The updated labels follow a December 2011 hearing of two Food and Drug Administration committee review of all scientific data on drospirenone pills. The new labeling includes additional information from recently published studies evaluating the risk of venous thromboembolism (VTE) in women taking birth control pills containing drospirenone.1-6 The labels state drospirenone OCs might be associated with a higher VTE risk pills containing levonorgestrel or some other progestins. Epidemiologic studies that compared the risk of VTE reported that the risk ranged from no increase to a three-fold increase, the labels note. Before initiating use of a drospirenone-containing pills in a new user or a woman who is switching from a contraceptive that does not contain the progestin, consideration must be given to the risks and benefits of the new method in light of potential VTE risk.

How to counsel?

What are important points for clinicians to emphasize with patients when it comes to discussing the potential risk of VTE from OCs?

"My immediate answer is that VTE risk is not an important point to emphasize," says Elizabeth Raymond, MD, MPH, senior medical associate at Gynuity Health Projects, New York City. Raymond is lead author of a current analysis on how to put such risks into perspective.7

The new paper reviews the currently available data. Researchers conclude that the important message for patients, clinicians, and policymakers lies in the fact that the benefits of all contraceptive methods markedly outweigh their risks, primarily because they prevent pregnancy, an inherently hazardous condition.

According to Raymond, important points to include in Pill counseling are:

  • Oral contraceptives, when taken correctly, are highly effective in preventing pregnancy, which is a "huge" health benefit.
  • OCs also provide a host of non-contraceptive benefits, such as prevention of certain types of cancer, relief of menstrual disorders, and treatment of acne and endometriosis.
  • Oral contraceptives are safe. While they sometimes cause side effects that can be troublesome (which clinicians should counter with management strategies) such side effects generally are not medically dangerous. Serious side effects, such as VTE, are very rare.
  • The benefits of oral contraceptives markedly outweigh their risk. On average, a woman who does not want to be pregnant is healthier if she takes OCs than if she does not.
  • A Pill user can maximize such benefits by using OCs every day and by not stopping use unless a concrete plan is set in place for alternative contraception.

Clinicians should provide each woman with whatever brand of OCs she is most likely to use consistently and continuously, says Raymond. Be sure to take into account the patient's individual pReferences, which might relate to side effects, cost, availability, and familiarity.

"If she is uneasy about VTE, then reassure her that although OCs do increase VTE risk, this condition is rare, and that whether different brands are associated with higher risk is not clear — but in the end, give her a brand that she's truly comfortable with," states Raymond.

References

  1. Parkin L, Sharples K, Hernandez R, 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.
  2. 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.
  3. Dinger JC, Heinemann LA, Kühl-Habich D. The safety of a drospirenone-containing oral contraceptive: final results from the European Active Surveillance Study on oral contraceptives based on 142,475 women-years of observation. Contraception 2007; 75:344-354.
  4. Seeger JD, Loughlin J, Eng PM, et al. Risk of thromboembolism in women taking ethinylestradiol/drospirenone and other oral contraceptives. Obstet Gynecol 2007; 110(3):587-593.
  5. Lidegaard Ø, Løkkegaard E, Svendsen AL, et al. Hormonal contraception and risk of venous thromboembolism: national follow-up study. BMJ 2009. Doi: 10.1136/bmj.b2890.
  6. Van Hylckama V, Helmerhorst FM, Vandenbroucke JP, et al. The venous thrombotic risk of oral contraceptives, effects of oestrogen dose and progestogen type: results of the MEGA case-control study. BMJ 2009. Doi: 10.1136/bmj.b2921.
  7. Raymond EG, Burke AE, Espey E. Combined hormonal contraceptives and venous thromboembolism: putting the risks into perspective. Obstet Gynecol 2012; 119(5):1,039-1,044.