The recent recommendations from a Food and Drug Administration (FDA) advisory committee about safety concerns with contraceptives may make women more leery when deciding which birth control is best for them. But even for women who are currently on birth control, understanding the risks is vital.
Pharmaceutical manufacturer Bayer is facing thousands of lawsuits questioning the safety of its birth control pills Yaz and Yasmin. The pills, which contain a combination of drospirenone and ethinyl estradiol, have been found in studies to put women at greater risk for life threatening blood clots than oral contraceptives with other types of hormones. Both Yaz and Yasmin have generic equivalents, which leaves some women questioning whether generic brands are safer than the brand name drugs.
The family of a 15-year-old North Carolina girl who was taking the birth control pill Yasmin to treat her acne and then died of a pulmonary embolism, are suing the drug’s maker Bayer, claiming the company did not adequately warn users of the potentially deadly health risks associated with its oral contraceptive.
Health Canada, Canada’s regulator of drugs, is conducting a safety review of the birth control pills Yaz and Yasmin to determine if the pills put women at greater risk for blood clots than other oral contraceptives.
The Food and Drug Administration (FDA) says it will keep a watchful eye on studies comparing drospirenone-containing birth control pills with levonorgestrel-containing oral contraceptives to determine if one is more dangerous to users. Two recent studies published in the British Medical Journal found pills with drospirenone were two to three times more likely to cause blood clots in women who used them.
Birth control pills with the hormone drospirenone include Bayer’s Yaz, Yasmin, Beyaz and Safyral, as well as generics Ocella, Gianvi, Loryna, Syeda, and Zarah. The FDA says it hopes to have data later this summer from an 800,000-person study it commissioned to examine the risks.
Two new studies showing an increased risk in venous thromboembolism (VTE), or blood clots in the lungs, in women who use Yaz birth control pills and oral contraceptives with similar hormone formulations, has resulted in a special drug safety notification from the Food and Drug Administration (FDA). Yaz, made by Bayer, contains the progestin drospirenone. The same hormone is used in Bayer’s Yasmin, Beyaz and Safyral, as well as generics such as Ocella, Gianvi, Loryna, Syeda, and Zarah.
Lawyers for the pharmaceutical giant Bayer are overwhelmed by the “overly burdensome discovery requests” made by attorneys for the thousands of women and their family members who have filed suit against Bayer. The drug company has turned over some 40 million pages of documents related to Yaz and Yasmin’s warnings, safety, labeling and sales and market, and say they have up to 30 million more pages yet to surrender. Bayer’s attorneys have asked for a protective order to stop the mountain of paperwork, but the plaintiffs attorneys say they want all the documents as they are imperative to the lawsuit filed against the drug company.
Sales of Yaz birth control pills fell 15 percent in the second quarter of 2010, which Bayer Corp. blames on increased competition from generics marketed in the United States by Teva Pharmaceutical Industries. Teva introduced its Yaz copycat, Gianvi, earlier this year only to be slapped with a patent lawsuit by Bayer. It’s not the first lawsuit Bayer has filed against Teva in hopes of protecting the multimillion dollar market share it has enjoyed with Yaz.
Bayer has dropped its patent suit in Delaware against Teva Pharmaceuticals Industries Ltd., and Barr Pharmaceuticals for infringing on its multi-million-dollar-selling oral contraceptive Yaz. Bayer had filed the lawsuit claiming TVA’s generic version of Yaz, known as Gianvi, infringed on Yaz. However, Bayer says it is maintaining its patent suit against Teva and Barr in Nevada District Court.
District Judge David Herndon is ordering sales representatives who pushed the oral contraceptives Yasmin, Yaz, Ocella and Gianvi to produce all their files and communications for national litigation. The order covers “all written materials, video and/or audio tapes” and includes training materials, e-mails, voice mail transcripts, summaries of meetings, incentive and goal plans, and all communications between representatives and managers. Herndon also ordered Bayer Health Care Pharmaceuticals, Bayer Schering Pharma, Barr Laboratories, and Teva Pharmaceuticals to produce records from their facilities.
