FDA Drug Safety Communication: Safety Review Update on the Possible Increased Risk of Blood Clots with Birth Control Pills Containing drospirenone

Safety Announcement

[09-26-2011]

The U.S. Food and Drug Administration (FDA) is 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 Contraception 2007; 75:344-54.

  • Lidegaard Ø, Løkkegaard E, Svendsen AL, Agger C. Hormonal contraception and risk of venous thromboembolism: national follow-up study. BMJ 2009; 339:b2890.
  • Van Hylckama V, Helmerhorst FM, Vandenbroucke JP, Doggen CJM, Rosendaal FR. The venous thrombotic risk of oral contraceptives, effects of oestrogen dose and progestogen type: results of the MEGA case-control study. BMJ 2009; 339:b2921.
  • Parkin L, Sharples K, Hernandez RK, Jick SS. 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; 342:d2139.
  • 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; 342:d2151.
  • Table 1. Approved Oral Contraceptives containing Drospirenone

    Brand name

    Generic name

    Drospirenone and ethinyl estradiol

    Drospirenone 3 mg and ethinyl estradiol 0.03 mg

    Ocella

    Drospirenone 3 mg and ethinyl estradiol 0.03 mg

    Safyral

    Drospirenone 3 mg, ethinyl estradiol 0.03 mg, and levomefolate calcium 0.451 mg

    Syeda

    Drospirenone 3 mg and ethinyl estradiol 0.03 mg

    Yasmin

    Drospirenone 3 mg and ethinyl estradiol 0.03 mg

    Zarah

    Drospirenone 3 mg and ethinyl estradiol 0.03 mg

    Beyaz

    Drospirenone 3 mg, ethinyl estradiol 0.02 mg and levomefolate calcium 0.451 mg

    Drospirenone and ethinyl estradiol

    Drospirenone 3 mg and ethinyl estradiol 0.02 mg

    Gianvi

    Drospirenone 3 mg and ethinyl estradiol 0.02 mg

    Loryna

    Drospirenone 3 mg and ethinyl estradiol 0.02 mg

    Yaz

    Drospirenone 3 mg and ethinyl estradiol 0.02 mg

    Patients should talk to their healthcare professional about their risk for blood clots before deciding which birth control pill to use. Known risk factors that increase the risk of a blood clot include smoking, being overweight (obesity), and family history of blood clots, in addition to other factors that contraindicate use of birth control pills.

    Posted: September 2011


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