Reports of Beyaz Problems Among Teens Evaluated in New FDA Report

A recent FDA report, which evaluated adverse event reports involving problems with Beyaz birth control among teens, found no unexpected evidence of specific pediatric safety concerns, although the agency is continuing to explore ways to better understand the increased risk of blood clots with Beyaz and other drospirenon-based birth control pills among women of all ages.

In advance of an FDA pediatric advisory committee meeting scheduled for September 11, the agency’s Division of Pharmacovigilance released a report (PDF) that summarizes post-marketing reports of problems with Beyaz, which were submitted to the FDA’s Adverse Event Reporting System (AERS).

The main focus of the review was to evaluate pediatric deaths and reports involving risks that may not be adequately contained on the warning label for Beyaz.

Introduced by Bayer in 2010, Beyaz is the first oral birth control pill that contains levomefolate calcium. It is the third variation of Bayer’s popular birth control products that contain drospirenone, a fourth generation progestin that is also contained in the controversial Yaz and Yasmin pills.

Drospirenone-based birth control pills like Beyaz, Yaz and Yasmin have seen substantial use among women between the ages of 10 and 24, amid aggressive marketing by the manufacturer that targeted teens and young adults. However, the products have been associated serious safety concerns, including an increased risk of blood clots when compared to some older birth control pills.

While the FDA’s Division of Pharmacovigilance acknowledged that some studies suggest the relative risk of blood clots from drospirenone pills appears to be higher for women under the ages of 30, the group found no unexpected evidence of pediatric safety concerns with Beyaz.

According to the division’s findings, 467 reports of Beyaz problems were submitted to the FDA by all users of the drug. Only 4%, or 19 of the 467 reports, involved pediatric patients between the ages of 0 and 17 years of age. Those reports included at least six cases of thromboembolic events, with three pulmonary embolisms and one retinal thromboembolism.

The report highlights that such blood clot problems are a known risk associated with Beyaz, and the warning label for Beyaz, Yaz, Yasmin and other drospirenon-based birth control pills was recently updated to provide additional language about a potential increased risk of venous thromboembolism when compared to older birth control pills containing levonorgestrel or some other progestins.

The FDA’s Division of Pharmacovigilance indicates that it will continue to monitor activities associated with Beyaz, and that the FDA’s Division of Epidemiology II is continuing to explore ways to better understand the possible increased risk of blood clots associated with all drospirenone birth control pills, including Beyaz, among women of all ages.

Concerns About Side Effects of Beyaz, Yaz and Yasmin

Bayer currently faces a number of Beyaz lawsuits, Yaz lawsuits and Yasmin lawsuits that allege they failed to provide adequate warnings to consumers and the medical community about the increased risk of blood clots from drospirenone, which could lead to a pulmonary embolism, deep vein thrombosis, heart attack, stroke or death.

In April 2012, the FDA required all drospirenone-based birth control pills to add new information about the risk to the warning labels, after a number of studies suggested that the contraceptives may be more dangerous than other oral contraceptives containing levonorgestrel or some other progestins.

The revised labels indicate that drospirenone side effects may triple the risk of blood clots when compared to pills containing other progestins, but notes that some studies have found no increased risk. The labels also include data from the FDA’s own study, which determined that drospirenone-based birth control pills were associated with a 1.5 fold increase in blood clot risk.

Bayer is now negotiating settlements for pulmonary embolism and deep vein thrombosis injuries associated with Yaz and Yasmin, on a case-by-case basis with certain law firms representing individuals who have experienced problems. However, the drug maker continues to face thousands of lawsuits over the warnings provided about the risk of problems with the birth control pills.