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FDA Drug Warnings

FDA Drug Safety Communication: Updated information about the risk of blood clots in women taking birth control pills containing drospirenone

This update is in follow-up to the FDA Drug Safety Communication posted on 9/26/11: Safety review update on the possible increased risk of blood clots with birth control pills containing drospirenone.

The U.S. Food and Drug Administration (FDA) has completed its review of recent observational (epidemiologic) studies regarding the risk of blood clots in women taking drospirenone-containing birth control pills. Drospirenone is a synthetic version of the female hormone, progesterone, also referred to as a progestin. Based on this review, FDA has concluded that drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills. FDA is adding information about the studies to the labels of drospirenone-containing birth control pills. See Table 1 for a list of drospirenone-containing products.

Women should talk to their healthcare professional about their risk for blood clots before deciding which birth control method to use.

Healthcare professionals should consider the risks and benefits of drospirenone-containing birth control pills and a woman’s risk for developing a blood clot before prescribing these drugs.

The studies reviewed did not provide consistent estimates of the comparative risk of blood clots between birth control pills that contain drospirenone and those that do not. The studies also did not account for important patient characteristics (known and unknown) that may influence prescribing and that likely affect the risk of blood clots. For these reasons, it is unclear whether the increased risk seen for blood clots in some of the epidemiologic studies is actually due to drospirenone-containing birth control pills.

The revised drug labels (Beyaz, Safyral, Yasmin and Yaz) will report that some epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products when compared to products containing levonorgestrel or some other progestins, whereas other epidemiological studies found no additional risk of blood clots with drospirenone-containing products. The labels also will include a summary of the previously released results of an FDA-funded study of the blood clot risk.

To put the risk of developing a blood clot from a birth control pill into perspective: The risk of blood clots is higher when using any birth control pills than not using them, but still remains lower than the risk of developing blood clots in pregnancy and in the postpartum period.

These studies were discussed at the joint meeting of the FDA’s Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on December 8, 2011. FDA’s briefing document for this meeting is found here.

Previous Drug Safety Communications related to the risk of blood clots with birth control pills that contain drospirenone were posted on May 31, 2011, September 26, 2011, and October 27, 2011. The DSC posted in May 2011 updated the public about FDA’s ongoing safety review of two new studies that reported a greater risk of blood clots for women taking drospirenone-containing products as compared to the risk in women taking products containing other progestins. Previously published studies had reported conflicting findings. The DSC posted in September 2011 discussed preliminary results from a FDA-funded study suggesting an approximately 1.5-fold increase in the risk of blood clots for women who use drospirenone-containing products compared to users of other hormonal contraceptives. The DSC posted in October 2011 released the final study report and appendices from the FDA-funded study in advance of the Joint Meeting of the Drug Safety and Risk Management Advisory Committee and Reproductive Health Drugs Advisory Committee Meeting.

Related Information

Safety Announcement

[6-15-2011] Seated around a U-shaped configuration of tables sat the 26 member FDA Advisory Committee — all scientists or physicians gathered to discuss the risks of birth control pills containing DRSP. They focused on the risks as described in recent studies, including the FDA’s own study that looked at over 800,000 women during a six year time period. The results of the FDA study concluded that new users of Yasmin may be twice as likely to experience a blood clot as users of other birth control pills containing the progestin Levonorgestrel.

Simple Steps to Evaluate Your Case

It will speed up the process if you have the following information available before you contact us:

  • When did you take the birth control pills from Bayer (Yaz, Yasmin, Ocella)?
  • Date and type of injuries that occurred as a result of taking Yaz, Yasmin, Ocella?
  • If you have had blood clots, DVT, PE or any of the other Yaz, Yasmin, Ocella side effects let us know.
  • Detailed information of your injuries and emotional set backs caused by taking Yaz, Yasmin, Ocella.

Our firm works on a contingency basis which means you will not be asked to pay any money out of pocket.

This process will be very easy. Please feel free to answer all questions honestly as your information is confidential.

This process will be very easy. Please feel free to answer all questions honestly as your information is confidential.

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