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Safyral 26 articles

Bayer introduces new hormone-releasing IUD Skyla

The Food and Drug Administration (FDA) has approved a new contraceptive device  made by Bayer HealthCare Pharmaceuticals. Skyla, an intrauterine device (IUD) that releases the hormone levonorgestrel, is placed in the uterus to prevent pregnancy for up to three years. Skyla was found to be more than 99 percent effective at preventing pregnancy and is an attractive contraception alternative to the birth control pill, which must be taken daily. The device is a small, flexible plastic T-shaped device containing 13.5 mg of the progestin hormone levonorgestrel. Because Skyla slowly releases levonorgestrel into the uterus, only small amounts of the hormone ... Read More

Bayer shells out millions to settle more Yaz lawsuits

Bayer, maker of the blockbuster birth control pills Yaz and Yasmin, will pay at least $120 million to settle about 500 lawsuits claiming that the pills caused dangerous and sometimes deadly blood clots. The settlement is the first wave of resolutions expected from Bayer over its oral contraceptives. Bayer officials said the company agreed to pay an average of about $220,000 per case to resolve the lawsuits. The case was the first set for trial of more than 11,000 lawsuits over injuries allegedly caused by the drugs. The settlement comes just days after the Food and Drug Administration (FDA) ordered ... Read More

FDA puts stronger blood clot warnings on Yaz, Yasmin birth control pills

Yaz and other newer birth control pills that contain the hormone drospirenone will get stronger warnings on their labels warning users that the drugs may be more likely than older oral contraceptives to cause blood clots, the Food and Drug Administration (FDA) announced. The new labeling will apply to Yaz, Yasmin, Beyaz, and Safyral, which are all made by Bayer. The pills are among the top selling oral contraceptives in the United States. They were marketed not only as a drug to prevent pregnancy, but also as a medication to help clear up acne and ease symptoms of premenstrual disorders. ... Read More

Generic Yaz will include same blood clot warnings

Watson Pharmaceuticals has launched Vestura, a generic version of Bayer’s blockbuster birth control pill Yaz. Like their brand-name counterpart, these pills will also carry a safety announcement on their packaging, warning users that studies suggest the drospirenone-containing pills may put users at greater risk for developing life threatening blood clots. Yaz, as well as the brands Yasmin, Beyaz, Safyral, and other generic varieties, combine the hormones drospirenone and ethinyl estradiol. Yaz and its generic versions had sales of about $510 million last year alone. Watson hopes to take a bite out of those profits. However, just as Watson was vying ... Read More

Watchdog group pushes FDA panel to revote on Yaz safety

A consumer watchdog group is calling for a revote by a Food and Drug Administration (FDA) advisory panel, after discovering that some members of the panel had ties to drug companies that made the pills under review. The FDA panel was charged with reviewing studies that showed a newer generation of birth control pills containing the hormone drospirenone put women at greater risk for life threatening blood clots than other oral contraceptives with other hormones. Drospirenone-containing pills include Yaz and Yasmin, made by Bayer. The drug company also sells versions of the pills containing folic acid under the brand names ... 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

Birth control called ‘secondary cause of death’ in young woman taking Yaz

It was mere hours after Rebecca Bapp called her parents to say that she wasn’t feeling well that the 21-year-old was dead. Mysteriously, her health declined so rapidly even doctors were baffled by what was making her so ill. Not long after her parents rushed her to the hospital, she was placed on a breathing machine and sedated. She coded three times before she gave up her fight for life. Confused by her daughter’s sudden illness, Rebecca’s parents ordered an autopsy. The primary cause of death was a blood clot in her heart. “The secondary cause of death was her ... 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