In late September 2010, the FDA approved a “new” birth control pill called Beyaz. The lawsuit-beleaguered pharmaceutical company Bayer manufactures the drug. Beyaz is short for “Beyond Yaz,” in reference to Yaz, an earlier form of the same birth control formula. Beyaz includes a folate supplement in the pill. Beyaz could prove instrumental in Bayer’s undoing if more than 4,000 lawsuits against Bayer meet with success.
The lawsuits claim that Bayer didn’t properly test the active ingredients in Yaz, Yasmin, Ocella, and now Beyaz. Additional complaints allege that women suffered side effects ranging from gallbladder disease and thromboembolism to heart attack and stroke. The plaintiffs all share the claim that Bayer did not adequately warn them about the high risk of side effects incurred by taking Yaz when compared to other birth control pills without drospirenone, the main ingredient targeted in the Yaz lawsuits.
The official Yaz web site reports that the drug can harm fetuses and contaminate breast milk and should not be taken if pregnant. This contradicts the advertising campaign waged by Bayer for Beyaz claiming that adding folic acid to Yaz constitutes a better chance for a healthy fetus. If the lawsuits against Bayer win, it is possible that Yaz will be withdrawn from the market with Beyaz along for the ride.
A huge study by the British Journal of Medicine in early September 2009 revealed that drospirenone “causes a greater-than-usual number of blood clots compared to older pills,” CBS Business Network reported. Apparently neither the FDA nor Bayer took the study results or the thousands of pending lawsuits into consideration when moving forward and releasing Beyaz to the public.
References:
Bayer Healthcare Pharmaceuticals Staff. (September 27, 2010) “U.S. FDA Approves New Oral Contraceptive That Also Raises Folate Levels.” Retrieved on October 21, 2010 from PR Newswire.
Edwards, Jim. (September 28, 2010) “Bayer Pushes Its Luck With Birth Control Pill That Promotes Healthy Pregnancy.” Retrieved on October 21, 2010 from the CBS Business Network.
Edwards, Jim. (September 11, 2009) “BMJ: Ingredient in Bayer’s Yaz Causes More Blood Clots Than Rivals.” Retrieved on October 21, 2010 from the CBS Business Network.