While the results are not yet final, the FDA did find the early data disturbing enough to release preliminary findings showing that women taking the new contraceptives stand a 1.5 to 2 times greater chance of experiencing the potentially fatal side effect than women using the older types of birth control pills.
Other, older types of birth control typically contain the active ingredient levonorgestrel instead of drospirenone.
The FDA-funded study analyzed women taking one of 11 different types of birth control pills, most of which are the same as or the generics of Yaz, Yasmin and Ocella. The FDA also released additional information for patients about the pills containing drospirenone, and advised women to be aware of blood clot symptoms, including persistent leg pain, severe chest pain, or sudden shortness of breath. It is suggested that women experiencing any of these symptoms call their healthcare professional immediately.
Bayer Corporation, the maker of Yaz, Yasmin and Ocella, has been under scrutiny since the FDA publically warned the company about their marketing techniques that “minimize serious risks associated with the use of the drug [Yaz]” in an October 2008 letter.
The letter also reprimanded Bayer for their “misleading” commercials about the efficacy of Yaz, Yasmin and Ocella, which leads views to believe that the birth control pills will alleviate symptoms like irritability, moodiness, feeling anxious, bloating, fatigue, muscle aches, headaches, increased appetite, and acne, even though there are no clinical studies to prove this claim.
The FDA’s Advisory Committee for Reproductive Health Drugs and the FDA’s Drug Safety and Risk Management Advisory Committee will be holding a joint meeting regarding the findings of this study on December 8, 2011.
Zoll, Kranz and Borgess will be providing complete coverage of the issues discussed in this meeting, which we will post on our blog. For answers to additional questions on what to do if you have experienced a blood clot while taking Yaz, Yasmin or Ocella, contact us toll-free at 888.841.9623 or via email at Anneke@ToledoLaw.com.