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Bayer settles a small fraction of Yaz, Yasmin lawsuits

Bayer has agreed to settle about 70 of the approximately 11,300 lawsuits against the drug giant involving its blockbuster birth control pills Yaz and Yasmin, according to the company’s 2011 annual report. The terms of the settlement were not disclosed, but Bayer reportedly said the conditions were reasonable. The lawsuits were filed on behalf of plaintiffs who allege that using the oral contraceptives, as well as their generic equivalents Ocella and Gianvi, caused them or a loved one serious injury or death. The birth control pills contain the hormone drospirenone which recent studies have found put women at greater risk ... Read More

Drug companies may delay, withhold trial data from medical journals

Missing data from clinical trials that test the safety and efficacy of pharmaceutical drugs “distorts scientific record” and puts patients lives in danger, the British Medical Journal warns. The medical publication, which serves as a resource for policy makers and doctors, released several papers looking into the problem of unpublished trial data. One study from Yale University found that fewer than half of the 635 National Institutes of Health-funded trials were published in peer-reviewed medical journals within 30 months of trial completion. This includes experimental drugs as well as those already licensed on the market. Lead researcher Joseph Ross said ... Read More

Women should be aware of blood clot risk with birth control pills, patches

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. Late last year, FDA advisory committees reviewed studies which suggested that birth control pills containing the hormone drospirenone put women at greater risk for blood clots than pills made with older-generation hormones. Blood clots are serious health problems because they can break loose and travel to the heart, lungs or brain causing serious complications ... Read More

FDA panel warns of elevated blood clot risk with patch, Yaz

A Food and Drug Administration (FDA) advisory panel said Friday that the Ortho Evra birth control patch, made by Johnson & Johnson, should remain on the market despite an elevated risk for blood clots. The panel voted 19-5 in favor of patch as an alternative contraceptive for women who are unable to take a daily birth control pill. While hormone-based birth control pills and patches carry a risk for dangerous blood clots, studies have shown that the Ortho Evra patch can put users at an even greater risk. Blood clots can be fatal because they can create blockages in the ... Read More

Blood clot warnings on birth control pills could impact user rates

Stronger warnings on packages of a newer class of birth control pills and government ruling to restrict the availability of the morning-after pill may make women leery of birth control in general, which could increase the rate of unwanted pregnancies or abortions, some advocacy groups warn. Last month, a Food and Drug Administration (FDA) advisory panel reviewed data about the safety of a class of birth control pills that contain the hormone drospirenone, which includes the top-selling Yaz and Yasmin, both made by Bayer. The panel voted to recommend stronger warnings be placed on drospirenone-containing pills based on studies that ... Read More

Why would FDA panel not ban Yaz over blood clot risk?

Why did an advisory panel of experts for the Food and Drug Administration (FDA) not vote to ban the popular birth control pill Yaz and other pills of its generation containing the hormone drospirenone, instead opting to recommend that the pills carry a stronger warning for life-threatening blood clots? There is no doubt that with all oral contraceptives there is a slight risk for blood clots. Bayer, maker of Yaz and a family of other drospirenone-containing pills such as Yasmin, Beyaz and Safyral, has consistently claimed its pills were no more as dangerous than other birth control pills. However, newer ... Read More

New studies show increased risk of blood clots with Yaz

A new study backs up concerns of previous studies that show birth control pills containing the hormone drospirenone, such as Yaz and Yasmin, are more likely to cause deadly blood clots than oral contraceptives made with older generation hormones. The study, released last month, puts the blood clot risk with drospirenone-containing pills at 43 to 65 percent greater when compared to pills with other types of hormones. The latest study is based on data from 330,000 Israeli women. Previous research, involving 835,826 women ranging in age from 10 to 55 who were taking pills like Yaz, suggested the blood clot ... Read More

FDA approves generic Yaz despite serious blood clot warnings

Yaz, and other birth control pills made with the hormone drospirenone, have been shown in studies to put women at greater risk for developing deadly blood clots, yet generic versions of the drug are still being approved for sale in the United States. Watson Pharmaceuticals Inc. has just been granted approval by the Food and Drug Administration (FDA) for Vestura, its generic version of Bayer’s Yaz. Watson wants to take a bite out of the $173 million in sales Yaz has generated for the 12 months ended on September 30. The drug company is currently in a patent dispute with ... Read More

FDA: Yaz, Yasmin put users at risk for dangerous blood clots

Drug regulators will take a closer look at the birth control pills containing the hormone drospirenone, such as Bayer’s popular pills Yaz and Yasmin, during a meeting with advisers next month. At issue is the safety of the pills, which the Food and Drug Administration (FDA) said in an announcement released this week puts women at a 74 percent greater risk of suffering from dangerous blood clots than other low-estrogen pills. The FDA cited recent studies that evaluated data from 835,826 women ranging in age from 10 to 55 who were taking pills containing drospirenone over time. The agency’s findings confirm previous ... Read More

Generic versions of Yaz, Yasmin just as dangerous as brand name pills

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. Generic drugs are what the Food and Drug Administration calls “copies of brand name drugs that have exactly the same dose, intended use, side ... Read More