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FDA to Investigate Blood Clot Risk of Popular Birth Control Pill

By Susan Brinkmann, OCDS Staff Journalist The Food and Drug Administration (FDA) has announced the launching of an investigation into oral contraceptives such as Yaz and Yasmin that contain drospirenone after new research suggests these pills increase the risk of blood clots more than other oral contraceptives. Two new studies published in the British Medical Journal in April found that birth control pills containing drospirenone, a type of progestin, had a two- to three-fold higher risk of causing a blood clot in a deep vein, known as a venous thromboembolism, than pills containing a different progestin. “Other studies have not reported an increase in risk," the agency said in a safety alert posted online on Tuesday. "The FDA is currently evaluating the conflicting results from these studies and will look at all currently available information to fully assess the risks and benefits of drospirenone-containing birth control pills.” Such pills include Yaz (generics Gianvi and Loryna), Yasmin (generics Ocella, Syeda, and Zarah), Beyaz, and Safyral, according to the FDA. The problems with Yaz and Yasmin have been on-going. According to an article appearing in the July, 2009 issue of the National Law Journal, attorney Janet G. Abaray filed a lawsuit on behalf of a woman who suffered a stroke after taking Yasmin. Court papers say that from the first quarter of 2004 through the third quarter of 2008, over 50 reports of death among users of Yasmin and Yaz have been filed with the FDA. Some deaths occurred in women as young as 17 years old. Yasmin and its sister drug, Yaz, manufactured by Bayer Healthcare, are the first birth control pills marketed in the U.S. which contained drospirenone. Bayer introduced the products in April 2001 (Yasmin) and 2006 (Yaz). According to Abaray’s lawsuit, studies done prior to FDA approval indicate that drospirenone has more dangerous side effects than other progestins. Specifically, drospirenone causes an increase in potassium levels in the blood which can lead to a condition known as hyperkalemia if the potassium levels become too high. Hyperkalemia can cause heart rhythm disturbances which can be fatal if left untreated. Abaray, said her firm, Burg, Simpson, Eldredge, Hersh and Jardine, has amassed evidence showing that there are many more adverse events reported to the FDA for Yaz and Yasmin than for other birth control pills that have been around longer. For instance, besides the risk of blood clots, heart attack and stroke, other side effects of drospirenone include liver damage, depression or emotional changes, migraines, breast lumps, high blood pressure, high cholesterol and signs of allergic reaction including unexplained rashes, hives, itching, unexplained swelling, wheezing and difficulty breathing or swallowing. “The drug companies have known [about the adverse effects] for some time,” Abaray said, “and they have not warned the doctors or their patients.” Instead, Bayer has been investing millions in trendy ad campaigns that promote the drug to women under 35. The campaign resulted in billions in worldwide sales – and some serious conflicts with the FDA. In October 2008, the FDA sent a warning letter to Bayer citing the company for running false and misleading television ads about Yaz. Aside from minimizing serious risks associated with the pills, the ads overstated the drug’s efficacy and promoted its use for conditions such as premenstrual syndrome for which it has not been approved. Bayer agreed to spend $20 million on a corrective advertising campaign. Even though the company admits that 74 lawsuits have been brought by women who say they developed serious health problems after taking Yaz or Yasmin, Bayer continues to defend the safety of Yaz and Yasmine. The company cites a large-scale study in Europe which reported no difference in the risk of cardiovascular problems or death in women taking drospirenone birth control pills compared to women who took pills that contain levonorgestrel, a progestin that has been used in pills since the 1970s. However, it should be noted that this study was funded by Bayer. In addition to the recently published studies, the British Medical Journal also reported on two studies in 2009 which were conducted on Danish and Dutch women. Both studies found a higher risk of venous blood clots for women taking newer progestins, including drospirenone. © All Rights Reserved, Living His Life Abundantly®/Women of Grace®