In May of 2010with thousands of lawsuits pending against Bayer for birth control drugs Yaz, Yasmin, and Ocellathe FDA found it suitable to approve Bayer’s new pill, Natazia. In September of 2010, with over 4,000 lawsuits filed, the FDA approved the release of Beyaz, another birth control pill with the exact same active ingredients as the contested Yaz and Yasmin. Natazia contains a different formulation of ingredients, but still may draw fire as the litigation proceeds.
The original PR Web press release penned by Bayer reports, “The use of Natazia is associated with increased risks of several serious conditions including venous and arterial thrombotic and thromboembolic events (such as myocardial infarction, thromboembolism, stroke), hepatic neoplasia, gallbladder disease, hypertension, ruptured ovarian cyst and uterine leiomyoma.” It remains to be seen just how many birth control pills Bayer plans to release that will be required to carry this warning.
The FDA appears to have shed earlier concerns for the safety of consumers in relation to Bayer’s controversial birth control products. It would make more sense to put a moratorium on the release of new pills with potentially dangerous ingredients while the jury is still out on the legality and safety of the pills. However, the FDA disagrees and feels it is perfectly fine to continue approving questionable drugs.
An Injury Board article reported, “Studies have shown the risks of blood clots to be substantially higher than those seen with other birth control medications with similar efficacy,” in regard to Beyaz. It does not seem likely that Bayer or the FDA will remain unscathed before the dust settles after thousands of lawsuits find a conclusion.
Bayer Healthcare Pharmaceuticals Staff. (May 6, 2010) “U.S. FDA Approves Natazia(TM), a New Oral Contraceptive for the Prevention of Pregnancy.” Retrieved on October 21, 2010 from PR Newswire.
Bayer Healthcare Pharmaceuticals Staff. (October 21, 2010) “Important Safety Information About Natazia, Including Boxed Warning.” Retrieved on October 21, 2010 from the Natazia website.
Edwards, Jim. (May 7, 2010) “More Questions Than Answers About Safety of Natazia, Bayer’s New Contraceptive.” Retrieved on October 21, 2010 from the CBS Business Network.
Fulmer, Brenda. (September 27, 2010) “Bayer’s Beyaz -- Cause for Shame, Not Celebration.” Retrieved on October 21, 2010 from the Injury Board Blog Network.