September 26, 2011 — The FDA has completed a review of two 2011 studies looking at the risk of blood clots for women using drospirenone-containing birth control pills. While it has not reached a formal conclusion, the FDA says there is reason for concern, prompting a joint meeting of two FDA committees to discuss the risks and benefits of drospirenone-containing birth control pills compared to other hormonal contraceptives.
In its updated Drug Safety Communication announcement, the FDA said it hasn’t reached a conclusion, but remains concerned about the potential increased risk of blood clots with the use of drospirenone-containing birth control pills. These blood clots occur in veins and usually develop in the lower leg or thigh, but can be particularly dangerous if they travel to other areas of the body — like the lungs.
While all birth control pills pose a risk of blood clots, several recent studies suggest there is an increased risk in women taking pills containing drospirenone, higher than in women taking pills containing progestin levonorgestrel. Most birth control pills work by combining a synthetic version of the female hormone progesterone (known as progestin) with a synthetic version of the female hormone estrogen. Drospirenone is a progestin.
In March 2011, the FDA warned of the possible risk of drospirenone-related blood clots, but said it would conduct a review of two studies and their findings, as well as conduct an independently FDA-funded study.
Preliminary results of the FDA-funded study suggest an 1.5-fold increase in the risk of blood clots in women who use drospirenone-containing birth control pills versus other hormonal contraceptives.
To put this in perspective, if the average rate of blood clots is 6 in 10,000 women, drospirenone-containing oral contraceptives elevates this risk to 10 in 10,000 women.
After completing the review of other studies, the FDA said that at best, the various studies offered contradicting evidence. Yet, the FDA recommended the need of a joint meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on December 8, 2011 in order to discuss the risks and benefits of drospirenone-containing birth control pills.
The FDA reviewed 6 published studies that evaluated the risk of blood clots in women taking drospirenone-containing birth control. Two were postmarket studies required by the FDA or European regulatory agencies. These studies did not report any difference in blood clot risk. However, two studies from 2009 reported a 1.5 to 2-fold higher risk of blood clots in women taking drospirenone-containing birth controls compared to users of other hormonal contraceptives. Two articles published in 2011 in the British Medical Journal reported a 2 to 3-fold greater risk of blood clots. The studies only focused on medications containing 3 mg of drospirenone and 0.03 ethinyl estradiol (an estrogen). The FDA does not know whether these results apply to drospirenone-containing products with lower doses of estrogen (0.02 mg ethinyl estradiol).
Despite the contradictory information, the FDA believes there is reason for concern. Said the FDA:
“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.”
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