FDA has scheduled its meeting in December this year to discuss on side effects of Yaz, Yasmin. One of the most popular medicines from Bayer pharmaceuticals, Yaz has drawn FDA attention for all the wrong reasons lately. It along with the same class drug Yasmin, which is also produced by Bayer, has been linked to fatal side effects.

Yaz was originally manufactured by Berlex Labs. Its production started in 2001. Later Yasmin another contraceptive in same class was introduced. Bayer acquired Berlex Lab in 2006. Since then it is enjoying the huge sale of both the medicines. Yaz, was one of its kind contraceptive to contain drospirenone, later Yasmin followed the suit. Both of these drugs are being linked to fatal side effects.

These medicines are also used to treat mild acne and premenstrual dysphoric disorder (PMDD). Bayer is being showered by Yaz and Yasmin lawsuits. These lawsuits allege Bayer of misrepresentation of facts and side effects of the medicines.

Previously in 2009 as asked by FDA, Bayer HealthCare ran an advertising campaign to correct misrepresentations regarding Yaz. FDA has also issued warning to Bayer regarding Yaz and Yasmin safety concerns time to time. Different studies worldwide have also related these medicines to fatal diseases such as Hyperkalemia, pulmonary embolism, deep vain thrombosis (DVT), gall bladder diseases and heart attack.

FDA also did a safety review of Yaz, but it failed to deliver any conclusion. FDA found that studies related to Yaz side effects are not comprehensive and cannot be considered as the judgmental ones. It later scheduled a meeting with the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on December 8th, 2011 to discuss on the side effects of Yaz. They will also discuss on studies published in this concern.

FDA has plans to review not only Yaz but other contraceptives on its line too. It will review Yaz, Yasmin and other generic drugs such as Ocella, which contain drospirenone. The drospirenone is a synthetic hormone same as hormone progestin. FDA has warned patients and doctors alike regarding use of these drugs.

The meeting will try to come on a conclusion that whether these drugs increase the risk of blood clots compared to other contraceptive drugs. Many studies have concluded that these drugs increase the risk two or three folds. Some of the studies have concluded otherwise.

FDA has found its review till date as conflicting, thus it has decided to have a meeting with both Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. Meanwhile Bayer has said that it is working with the FDA on the safety review of these drugs.

Bayer healthcare has been facing numerous lawsuits related to side effects of these drugs. The conclusion drawn in this meeting will have wide impact on Yaz and Yasmin lawsuits and their settlement. If FDA comes with a decision highlighting the side effects of these drugs or it decides t ban them, it will be a big blow for Bayer Healthcare.