Dr Shezad Malik Law Firm is writing this open letter to the FDA. We are requesting the U.S. Food & Drug Administration (FDA) to complete its ongoing safety review of Yaz, Yasmin and other birth control pills containing the synthetic progestin, drospirenone, as soon as possible.
Recently, a FDA-funded study confirmed that women who use such birth control pills have an increased risk of blood clots (known as venous thrombosis) when compared to women using other hormonal contraceptives made with an older progestin called levonorgestrel.
In a report released October 27, the FDA warned that in the study, women taking pills with drospirenone were 75 percent more likely to experience clots compared to those taking other oral contraceptives.
These results were also confirmed by a recent Israeli medical study. Read the published article here. This is the second time this fall, that the FDA has issued a warning regarding increased blood clots risks associated with drospirenone-containing birth control pills. The latest FDA warning also came just days after the British Medical Journal published a separate study out of Denmark which found that women taking birth control pills with newer progestins, including drospirenone, may double their risk of suffering a blood clot compared to women using other hormonal contraceptives made with levonorgestrel.
Unfortunately, the FDA has not advised women to stop using Yaz, Yasmin and other birth control pills made with drospirenone. The agency has scheduled a joint meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee for December 8, 2011, to discuss the safety of drospirenone birth control pills.
More than 9,000 lawsuits have been filed against Bayer Healthcare Pharmaceuticals, Inc., which markets Yaz and Yasmin in the United States, and Bayer Pharma AG, which manufactures drospirenone and ethinyl estradiol, the progestin and estrogen contained in Yaz and Yasmin. These women allege the following injuries including, strokes, pulmonary emboli, deep vein thrombosis, blood clots, and gallbladder disease.
Particularly worrisome is the number of gallbladder disease and gallstones we are seeing in young women, some as young as 16 years old. Typically the gallbladder disease is a disease of older women in their forties and it is extremely unusual to see such young girls with these types of side effects and to subject them to gallbladder surgery.
The exact mechanism of gallbladder disease and gallstones is not immediately apparent, medical experts think it may be due to the interaction between drospirenone diuretic and antimineralocorticoid action and ethinyl estradiol. It appears to be a signature disease side effect.
Over 7,000 such lawsuits have been consolidated in the Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Products Liability Litigation (MDL No. 2100) currently pending before the Honorable Judge David R. Herndon in the United States District Court for the Southern District of Illinois.
Drospirenone containing birth control pills: Yaz, Yasmin, Ocella, Safyral, Syeda, Yasmin, Zarah, Gianvi, Loryna.