FDA Concerned of Blood Clot Potential of Drospirenone Birth Control

September 26, 2011 — After completing a review of two recent studies, the FDA says it has not reached a conclusion as to the safety of drospirenone-containing birth control, but it does believe there is cause for concern, as past research has suggested drospirenone-containing birth control increases risks of blood clots.

The FDA is asking a joint meeting of two committees to discuss the risks and benefits of drospirenone-containing birth control pills compared to other forms of hormonal contraceptives.

In an updated Drug Safety Communication announcement, the FDA said it reviewed two 2011 studies that found a correlation between birth control pills containing drospirenone and an increased risk of blood clots. While the FDA completes its own FDA-funded study, it is not giving a definitive conclusion on drospirenone-containing drugs, but is stating it remains concerned about the potential risk of blood clots. These blood clots usually occur in veins and develop in the lower leg or thigh, but can be particularly dangerous if they travel to the lungs.

In March 2011, the FDA initially warned of the possible risk of blood clots associated with drospirenone use. At the time, the FDA said it would review the findings of two articles published in the British Medical Journal, as well as conduct its own independent FDA-funded study on the risk of drospirenone-induced blood clots.

While all birth control pills pose a risk of blood clots, previous research suggested that women taking birth control pills containing drospirenone were at a higher risk of developing blood clots over women taking other pills containing progestin levonorgestrel. Most birth control pills contain a combination of two female hormones, progesterone (known as progestin) and estrogen. Drospirenone is a progestin.

After reviewing 6 total studies, the FDA concluded that the evidence was contradictory, at best. Two postmarket studies sponsored by the FDA or European regulatory agencies found no difference in blood clot risks between different birth control hormones. 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. Finally, two articles published in 2011 — the two most recently FDA reviewed articles — reported a 2 to 3-fold greater risk of blood clots.

While the FDA-funded study is on-going, preliminary data reflects the findings of the two 2009 studies.The FDA-funded study suggested an 1.5-fold increase in the risk of blood clots in women who used birth control pills containing drospirenone, versus other hormonal contraceptives. To put this into perspective, if the average number of blood clots occurred in 6 women out of 10,000, drospirenone-containing birth control pills would increase this risk to 10 women in 10,000.

The FDA warned all of these studies only focused on drugs containing 3 mg of drospirenone and 0.03 mg of ethinyl estradiol (an estrogen). The FDA does not know if the same results would apply to drospirenone drugs containing lower doses of estrogen (0.02 mg ethinyl estradiol).

Because of contradictory information, the FDA asked for a December 8, 2011 joint meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. These committee members will discuss the risks and benefits of drospirenone-containing birth control pills, as well as the risk of blood clots in drospirenone drugs versus other hormonal contraceptives.

In the meantime, the FDA said:

“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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