April 10, 2012 — After a U.S. Food and Drug Administration (FDA) panel voted in November 2011 to update the drug safety information on all drospirenone-containing birth control pills, the FDA has just issued a Public Safety Announcement that the new labels will be updated, and they will include warnings about the risk of blood clots. According to the statement, “The FDA has concluded that drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills.”
For women who are deciding what type of birth control pill to use, the FDA is now advising women to talk to their doctors about the risk of blood clots associated with drospirenone-containing birth control pills. Drospirenone is equally effective at preventing pregnancy compared to birth control with other types of progestin, but it has been associated with a slightly higher risk of blood clots.
The FDA’s final decision regarding the label updates comes as no surprise. In November of 2011, an FDA advisory panel voted 21-5 to update the warning information for all drospirenone-containing birth control pills, because the labels were inadequate to warn women about the life-threatening risk of blood clots.
The panel-members were concerned about the results of an FDA-funded study of drospirenone side effects, which involved 800,000 women and found a three-fold increased risk of blood clots in women taking drospirenone.
The new safety labels will warn that the risk of blood clots may be three times higher for drospirenone-containing birth control pills, compared to older types of synthetic progestin (such as levonorgestrel). The safety labels will also state that some studies have not found drospirenone associated with an increased risk of blood clots. However, there is enough evidence linking drospirenone to blood clots that the FDA has determined that women should be warned.
Drospirenone is a new, “fourth generation” version of a synthetic female reproductive hormone, progestin. Because birth control pills have been in wide use for decades, researchers have long known that all progestins increase a woman’s risk of developing a life-threatening blood clot. With older versions, around 4-6 women for every 10,000 suffered a blood clot. With drospirenone, around 10 women for every 10,000 are expected to suffer a blood clot.
The problem is that many women were unaware of this risk. Tens of millions of women decided to switch from older birth control pills to the drospirenone-containing pills, and subsequently, thousands of women have developed severe side effects. Blood clots can cause pulmonary embolism, heart attack (myocardial infarction), ischemic stroke, organ damage/failure, permanent disability, and death. Bayer now faces more than 11,000 lawsuits from women who have been injured by these medications, including at least 50 brought by family members of women who died after using drospirenone-containing birth control pills.
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