Despite the Food and Drug Administration’s (FDA) warnings to Bayer Healthcare Pharmaceuticals regarding Yaz and Yasmin for misleading advertising in letters sent in 2003, 2008, and 2009, the brands remain popular with women seeking birth control options. Perhaps this is partially the result of the very issues that the FDA warned about: lack of communication about associated risks, exaggeration of effectiveness, encouragement for non-approved uses, and baseless product superiority claims. However, on September 26th, the FDA issued a new communication on the administration’s website. This warning should concern all women taking Yaz or Yasmin.
The FDA’s recent communication regarded drugs containing drospirenone, which is a key ingredient in Yaz and Yasmin, marketed by Bayer. The government agency released the preliminary results of its study into drospirenone. This study involved roughly 800,000 women and showed an increase risk of the development of venous thromboembolism (VTE). VTEs are blood-clots, which generally originate in the legs and can travel through the right side of the heart and into the lungs. An embolism (blood-clot) in the lungs can be fatal. Symptoms include persistent leg pain and swelling, chest pain, and shortness of breath.
On December 8th of this year, the FDA will convene an outside team of medical experts to further explore the matter. The FDA’s reluctance to release a definitive opinion about drospirenone may also be due to several other conflicting studies regarding drospirenone. One of these other studies shows that the risk of blood-clot formation is actually higher in women who are not taking Yaz, Yasmin, and similar products. However, the FDA’s study, once completed, should help provide more concrete conclusions.
Many medical experts are advising that women who take Yaz or Yasmin speak to their physicians before discontinuing the pill’s use. Some are even cautioning women who have recently begun to use Yaz and Yazmin to first consider all other options. Given the life-threatening risks associated with a blood-clot, women should also pay attention to the side effects that Bayer has attempted to minimize in the past and judge if the potential risk is worthwhile.
What does the FDA’s study mean for you? If you are taking Yaz or Yasmin and have experienced a blood-clot, stroke, heart attack, deep vein thrombosis, or gallbladder disease, it’s important to carefully review all of your legal options. These medical conditions can not only impact your health, they can also place a large financial burden on your family and greatly impact your lifestyle. A Yaz lawsuit attorney in Florida can help you gain the compensation that you deserve.
You should never have to pay for the negligence of others. Let a Fort Lauderdale drug litigation attorney review your case and help you through this difficult time. Contact the attorneys at Levine & Glassman to learn more.