Things are getting even uglier between two pharmaceutical companies whose oral contraceptives will soon go head-to-head in America. First, Bayer announced it was suing Teva Pharmaceutical Industries for prematurely pushing Gianvi, its generic version of Bayer’s blockbuster birth control pill Yaz, also known as Yasmin.
Bayer’s multimillion dollar birth control pill, Yaz, will go head-to-head with generic competition with the introduction of Teva Pharmaceutical Industries’ Gianvi. Teva was awarded a 180-day marketing exclusivity period for Gianvi by the Food and Drug Administration after being the first company to file an Abbreviated New Drug Application (ANDA). Bayer isn’t taking the news lightly. The company says it plans to sue Teva for prematurely launching the new “girl” on the block, which Bayer says they are not legally permitted to do until July 2011.
Kathy Perea will not forget the pain she suffered when her gallbladder began to fail. “It was horrible,” the 27-year-old mother of five told KTNV-TV. “I was throwing up so much that the vessels in my eyes were bursting because I was straining myself so bad.”
Holly Grigg-Spall, columnist for the UK’s The Independent, says the revolutionary birth control pill had nothing to do with turning her into a women’s health writer and activist. In fact, it gave her something to complain about.
Swissmedic, the Swiss Agency for Therapeutic Products, has closed its formal investigation into contraceptives containing drospirenone, following the death of one young woman and of another woman who is now severely disabled. The agency says that although the risk of thrombosis, or blood clots, is higher with this generation of contraceptives, the risk remains “within reasonable limits.” Swissmedic says the drug will remain on the market there but the drugs are required to have updated information on their label to reflect an increased risk of serious injury.
Bayer Schering Pharma has announced it will update the label in the European market for its oral contraceptive Yasmin, a combination of ethinylestradiol and the diuretic drospirenone, also known by the brand name Yaz and the generic brand Ocella. The new label will include results of four epidemiological studies conducted by independent investigators that show the risk for venous thromboembolism, or blood clots, in Yasmin users is comparable to the risk found for women who use levonorgestrel-containing oral contraceptives.
An estimated 20 million Americans have gallbladder disease, a condition in which the bile in the gallbladder becomes concentrated and thickens. The condition most often affects people over 60 years of age, says Dr. Ronald Hoffman, an active clinician, author, radio host and lecturer. However, many young women have developed the condition, thanks to their oral contraceptive.
Drug company Bayer is facing more than 1,100 lawsuits alleging its popular birth control pill Yaz causes life-threatening blood clots. According to the pharmaceutical company’s 2009 annual report, 129 new suits were filed in November 2009 alone. Many suits have been consolidated into federal multi-district litigation, fueling speculation that more lawsuits are on the way.
Vicki Parsons had been on the popular Yaz birth control pill for just three weeks when her life nearly came to an end. It started with a pain in her foot that just days later had her in the hospital. She was diagnosed with blood clots – one in her leg and the other in her lungs. It was an odd diagnosis for a young woman with no history of the health problem and no habits, like smoking, that made her more susceptible to blood clots. After a battery of tests, the doctors determined it was her birth control pills that triggered the clots.
Bayer HealthCare is facing numerous lawsuits from women and their family members who say they were seriously injured or killed after taking the drug company’s blockbuster birth control pill, Yaz. Yet, Yaz remains the company’s top-selling pharmaceutical, generating a whopping $1.3 billion in the first three quarters of 2009, according to Medical Marketing & Media.
