Young Women & Girls at Greatest Risk for Beyaz Side Effects

A pharmacovigilance review has been conducted by the request of the FDA. The Division of Pharmacovigilance I (DPV) has been in charge of helping with the reviews. The main reason for the initial review was to evaluate pediatric deaths (ages 0 to 17) and pediatric reports of serious unlabeled adverse side effect events with Beyaz. It has been said that there is an increased side effect risk in younger women taking Beyaz in developing serious and life-altering adverse health conditions.

Part of the reviews consisted of gathering information from the Adverse Event Reporting System (ARES) between September 2010 and May 1, 2012. Since the reports going into the data base come in a voluntary basis it is estimated that many more adverse events are surrounding Beyaz side effects and the numbers should be much higher. The database consisted of 467 adverse events reported in July of 2012 related to Beyaz. Of this number, 10 were children ages 0-17 years of age.

Some of the adverse Beyaz side effects reported include the following:

* Blood clots
* Pulmonary embolism (PE)
* Myocardial infarction
* Deep vein thrombosis (DVT)
* Venous thromboembolism (VTE)
* Stroke
* Heart Attack
* Blood blockage in the eye
* retinal thromboembolism
* And even death

Beyaz is currently under an ongoing review funded by the FDA for risks associated with the birth control drug.  Beyaz contains drospirenone, which is the same synthetic progestin, levomefolate, and ethinyl estradiol contained in other leading birth control pills such as Yaz, Yasmin, and Ocella. Drospirenone is a hormone in some modern birth control medications that has been linked to the most serious health side effects. As a result of the negative findings of several studies, the makers of Beyaz have been ordered by the Federal Drug Administration to upgrade their label in relation to the side effect risks associated with Beyaz blood clots.

DPV I will continue to look into matters related to Beyaz. The DEPI-II will also continue to investigate the matters and increased risks associated with the drug as well as all drospirenone-containing products and women of all ages.

Beyaz Lawsuit MDL and Mass Tort

Because of the number of Beyaz lawsuits being filed, there has been a multidistrict litigation established in Illinois. It is referred to as MDL No. 2100.  There is also a Beyaz lawsuit mass tort in the New Jersey state court system. It is the hope that by consolidating these Beyaz lawsuits that the litigation process will go much smoother and result in a quicker resolution for the plaintiffs involved.