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FDA Drug Safety Communication: Safety review update on the possible increased risk of blood clots with birth control pills conta

Posted Sep 26 2011 11:53am
This update is in follow-up to the FDA Drug Safety Communication: Safety Review of possible increased risk of blood clots with birth control pills containing drospirenone on 5/31/2011.





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 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 (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 (See ), 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.  

A list of drospirenone-containing birth control pills is .   

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.  

Women currently taking a drospirenone-containing birth control pill should be informed of the potential risk for blood clots. FDA previously communicated preliminary information about these concerns to the public on May 31, 2011 . 

FDA has prepared a list of questions and answers to provide an overview of this potential safety issue.  FDA will continue to communicate any new information to the public as it becomes available.

Additional Information for Patients

  • If your birth control pill contains drospirenone, do not stop taking it without first talking to your healthcare professional.
  • Discuss any questions or concerns about your birth control pill with your healthcare professional.
  • Know the symptoms of blood clots, including persistent leg pain, severe chest pain, or sudden shortness of breath. Contact your healthcare professional immediately if you develop any of these symptoms.
  • Side effects from the use of birth control pills should be reported to the FDA MedWatch program, using the information in the "Contact Us" box at the bottom of the page.

Additional Information for Healthcare Professionals

  • Consider the risks and benefits of drospirenone-containing combination oral contraceptives for a specific patient in light of her risk for developing blood clots (venous thromboembolism, VTE) before prescribing a drospirenone-containing oral contraceptive.
  • Counsel patients about the current information regarding the risk of 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 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 (an estrogen). 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).
  • Adverse events involving oral contraceptives should be reported to the FDA MedWatch program using the information in the "Contact Us" box at the bottom of this page.

Data Summary 

FDA has reviewed six published epidemiologic studies that evaluated the risk of blood clots (venous thromboembolism, VTE) in women using birth control pills containing drospirenone. These studies have conflicting findings. Two were postmarketing studies required by the FDA or European regulatory agencies.1,2 These studies did not report any difference in VTE risk between drospirenone-containing products and products containing levonorgestrel or other progestins. Two publications from 2009, however, reported a 1.5- to 2-fold higher VTE risk in women who use drospirenone-containing contraceptives as compared to the risk in women who use levonorgestrel-containing contraceptives.3,4  More recently, two articles published in 2011 in the British Medical Journal reported a 2- to 3-fold greater risk of blood clots in women using oral contraceptives containing drospirenone rather than levonorgestrel.5,6 As with all epidemiologic studies, there are methodological issues that make interpretation of these conflicting results complex. FDA has not reached a conclusion on the risk for blood clots in women using drospirenone-containing birth control pills, but remains concerned about the potential increased risk. 

Initial data from an FDA-funded epidemiologic study exploring the association of blood clots with several different hormonal contraceptive products, including levonorgestrel-containing contraceptives, appear consistent with results from the 2009 and 2011 published studies. Although FDA's review is ongoing, the preliminary data from the FDA-funded study are consistent with an approximately 1.5-fold increase in the risk of blood clots for users of drospirenone-containing contraceptives compared to users of other hormonal contraceptives. To put this risk into perspective, if the risk of developing a blood clot among women using other hormonal contraceptives is about 6 women in 10 thousand, then the risk of developing a blood clot among women using drospirenone-containing oral contraceptives would be about 10 women in 10 thousand. The full study report of this study, along with the completed FDA review of the results of the study, will be presented and discussed at the joint meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee in December 2011. 

FDA notes that the available studies have only examined the risk of VTE in users of contraceptive pills that contain drospirenone and 0.03 mg of ethinyl estradiol (an estrogen) and not other pills that contain drospirenone combined with a lower dose of estrogen (e.g., 0.02 mg ethinyl estradiol). It is unknown at this time whether the reported VTE risk applies to all drospirenone-containing products.

References

  1. Seeger JD, Loughlin J, Eng PM, Clifford CR, Cutone J, Walker AM. Risk of thromboembolism in women taking ethinylestradiol/drospirenone and other oral contraceptives. Obstet Gynecol 2007; 110(3):587-93.
  2. 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; 75:344-54.
  3. Lidegaard Ø, Løkkegaard E, Svendsen AL, Agger C. Hormonal contraception and risk of venous thromboembolism: national follow-up study. BMJ 2009; 339:b2890.
  4. 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.
  5. 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.
  6. 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

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
Brand name Generic name

 

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