Pediatric Use of Beyaz Examined in New FDA Report

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What’s the problem?

The central focus of the FDA’s review of Beyaz was to evaluate pediatric deaths and reports involving serious side effects that may not be described on the drug’s warning label. While the report acknowledged that some studies seem to suggest that the relative risk of blood clots from drospirenone-based contraceptives was increased among users under the age of 30, the group found no unexpected evidence of pediatric safety concerns with Beyaz.

First approved by the U.S. Food & Drug Administration (FDA) in 2010, Beyaz is the first combination oral contraceptive (COC) that contains levomefolate calcium. It is the third incarnation of Bayer’s blockbuster line of drospirenone-containing birth control pills which includes Yaz and Yasmin. Yet despite their immense success and widespread popularity, contraceptives from this class have been repeatedly associated with various safety concerns, including an increased risk of blood clots when compared to safer, older types of birth control.

According to the FDA’s Division of Pharmacovigilance, 467 adverse event reports (AERS) involving problems with Beyaz have been submitted to the administration. Of these, only 19 (4%) involved minors under the age of 18. The reports involving pediatric patients included at least six cases of thromboembolic events, with three pulmonary embolisms (PEs) and one retinal thromboembolism.

The FDA’s study highlights the fact that blood clot side effects are a known risk associated with Beyaz and other drospirenone-based birth control pills. The administration recently required Bayer and other manufacturers of similar contraceptives to update their drugs’ warning labels to include verbiage about a potential increased risk of venous thromboembolism (VTE) when compared to birth control pills containing levonorgestrel, a ‘third generation’ synthetic progestin found in many older contraceptives.

Bayer currently faces a large number of Beyaz, Yaz and Yasmin lawsuits which allege that the company knew – or should have known – about the drugs’ potential to cause serious side effects, but that it failed to adequately warn the public and medical communities about these risks. The company is now in the process of negotiating settlements for PEs and deep vein thrombosis associated with Yaz and Yasmin on a case-by-case basis, with select law firms representing individuals who have experienced these problems. And though this is a step toward resolving its legal troubles, Bayer continues to face thousands of lawsuits filed in courthouses around the country on behalf of women allegedly injured by Beyaz, Yaz and Yasmin side effects.

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