Health Concerns Over Popular Contraceptives Yaz and Yasmin

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other health problems than some other birth control pills do.  Those critics, though, are up against a large European health study, sponsored by Bayer, the German pharmaceutical giant, that reported the opposite conclusion. The Bayer-financed study said that cardiovascular risks in women taking Bayer products were comparable to those taking an older formula of birth control pills.

But regulators are finding other faults with the Yaz franchise. The Food and Drug Administration early this year asked Bayer to correct misleading television commercials. The agency cited the company for not following proper quality control procedures at a plant that makes hormone ingredients.  Bayer said that the company had been served with 74 lawsuits brought by women who charge that they developed health problems after taking Yaz or Yasmin. The company says it intends to defend itself vigorously against the suits.

Birth control pills work by altering a woman’s hormone levels. Researchers have long known that taking a combination hormone birth control pill — which contains estrogen and a progestin hormone — can increase the risk of stroke and blood clots in the legs and lungs. That is because estrogen can play a role in blood coagulation. Indeed, since the introduction of oral contraceptives in the 1960s, drug companies have greatly reduced estrogen doses to decrease the risk of thrombosis, the medical term for blood clots.  With lower-dose estrogen pills now available, the safety debate, continuing for the last decade, has focused on whether the type of progestin in a formula may also play a role in the risk of cardiovascular problems.  Lawyers suing Bayer on behalf of plaintiffs who claim that they developed blood clots, heart attacks and other health problems because they took the drugs said they intended to argue that the company knew or should have known that the pills entailed a higher risk.

Last October, the agency sent Bayer a warning letter, citing the company for running two false and misleading television ads about Yaz. According to the letter, the ads overstated the drug’s efficacy, promoted it for conditions like premenstrual syndrome for which the drug is not approved, and minimized serious risks associated with the drug. In February, Bayer agreed to spend $20 million on a corrective advertising campaign to counteract misimpressions created by the original television spots.  Read the rest of the article

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