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Stronger Label Urged for Birth Control Products, Yaz and Yasmine

An advisory committee to the Food and Drug Administration has met to discuss popular birth control pills such Yas and Yasmin, and has concluded that the information on the labels should be strengthened.

Currently, the labels suggest that these contraceptives have blood clot risks similar to those of other birth control pills that combine estrogens and progestins. The panel, which voted 21 to 5 in favor of changing the labels, has said the labels should be strengthened to include more information about the possibility that the pills could lead to greater risk of blood clots. They stopped short of recommending that they warn that the drugs are more likely than other contraceptive pills to cause blood clots. Instead, the experts suggested that the labels note that the evidence about blood clots is conflicting.


The FDA, who does not have to follow the panel’s recommendations, has indicated concern in recent months as some studies have shown an elevated risk. Despite their decision to strengthen the labels, the advisory committee voted 15 to 11 that the benefits of the pills still outweigh the risks.

These contraceptives use a newer synthetic form of progestin called drospirenone, and it’s the drospirenone that has people questioning whether or not women are more prone to blood clots. Studies have shown differing results. Bayer, the maker of the drugs, has said that they pose no greater threat than other contraceptive pills, and that studies that show otherwise contain methodological flaws that undercut the strength of their results. They say that all forms of birth control somewhat elevate the risk of stroke and blood clots in the legs and lungs.

Despite Bayer’s findings, an FDA analysis reported that about 10 in 10,000 women taking pills with drospirenone will experience a blood clot or venous thromboembolism in a year, compared with 6 in 10,000 women using other hormonal contraceptives. While yet another study of 1.3 million Danish women found that women taking Yaz or Yasmin had double the risk of blood clots, compared with women taking the older contraceptives.
Before the advisory committee meeting, an FDA briefing document acknowledged that studies had revealed conflicting results, and said that new studies were needed, but that labels on the pills should be changed to inform the public of possible risks.

More than 10,000 lawsuits have been filed against Bayer claiming that women have been harmed by taking Yaz or Yasmin, including accusations of about 100 deaths linked to the contraceptives. According to former FDA commission, David Kessler, “Bayer presented a selective view of the data, and that presentation obscured the potential risks associated with Yasmin.” Kessler, who is serving as an expert witness for the plaintiffs, said that researchers found increased reports of blood clots in women using Yasmin in the United States, compared with those using three other pills, but did not provide that information to the F.D.A. in a 2004 safety review. He has also state that the company promoted the pill for alleviating premenstrual syndrome (PMS), when it was not approved for that use.
Bayer has stated that they have consistently worked with the FDA and other regulatory authorities around the world, and as new data became available, had worked with the agencies to make label updates as appropriate, and that they will continue to do so.