Yaz FDA Timeline

Although hormonal birth control pills have been widely used since the 1960’s, drug manufacturers have introduced new products in recent years that make use of a new generation of progestin called drospirenone. This synthetic progestin is found in Yaz, Yasmin and Ocella. While pills containing the new progestin promised many benefits to patients, these benefits have largely not materialized and the new hormone has also proven to be dangerous by, among other things, significantly increasing the risk of blood clots in patients.

Boston defective birth control lawyers at Jeffrey Glassman Injury Lawyers can help if you or a loved one has taken Yaz and suffered complications including a blood clot or cardiac event. Thousands of patients have already filed lawsuits against Bayer Schering, which manufactured and sold both Yaz and Yasmin through its U.S. affiliate, Berlex Laboratories Inc.

For patients harmed by Yasmin or a related birth control product, it is important to understand the steps that have been taken by the FDA in regards to this dangerous medication. The following timeline provides detailed information on action the FDA has pursued:

• 2001: Yasmin is approved by the FDA. Yasmin was a low-dose oral contraceptive that was the first to contain drospirenone.
• 2003: The FDA warns about misleading Yasmin advertising. The FDA chastised Berlex because its commercials failed to warn of the risk of elevated levels of potassium caused by Yasmin and overstated the effectiveness of Yasmin, implying without proof that Yasmin was better able to prevent pregnancy than other contraceptives.
• 2006: Yaz was approved by the FDA. Yaz has the same primary ingredients as Yasmin, but the two birth control pills have a different number of active pills (pills with hormones) and inactive pills (placebos with no hormones that patients take simply to keep on schedule). Yaz was first approved as a birth control method in 2006 and then was subsequently approved to treat premenstrual dysphoric disorder (PMDD), which is a severe premenstrual syndrome affecting around eight percent of women.
• 2007: The FDA approved Yaz for the treatment of moderate acne. This made Yaz the first birth control pill that was approved for three different uses: the prevention of pregnancy, treatment of PMDD and treatment of moderate acne.
• 2008: The FDA approved a generic version of Yasmin. The generic version was called Ocella.
• 2008: The FDA warns Bayer its ads were misleading. The FDA issued a warning to Bayer that its television ads were misrepresenting how effective Yaz was and incorrectly stating that the birth control was a cure for premenstrual syndrome.
• 2009: The FDA cites Bayer again. This time, Bayer was cited by the FDA for sponsored links on the Internet failing to mention the drug’s serious side effects and touting the drug as a treatment for PMS. The FDA also expressed concern that Bayer was overstating the effectiveness of Yaz as a treatment for acne.
• 2009: To comply with FDA orders to alert public to the dangers of Yaz, Bayer spent $20 million on advertisements.
• 2011: The FDA mandates that Bayer revise the Yaz label. Studies demonstrated that drospirenone significantly increased the risk of blood clots and was more likely than other oral medications to cause a blood clot to develop. The FDA mandated that Yaz and other drugs with drospirenone must be revised to contain a warning about the risk of blood clots.

An FDA Advisory Panel also decided in December of 2011 that Bayer was still failing to adequately warn the public about the dangers associated with the popular birth control drug.

Unfortunately, thousands of patients have already experienced complications and more than 10,000 lawsuits have been filed against the company. Bloomberg reported in 2008 that Bayer had set aside around $610.5 million to settle claims arising from Yaz and Yasmin complications and has already settled one category of clot cases for an average of $212,000 per case.

Plaintiffs who have sustained harm due to Yaz can still come forward to file a lawsuit or become part of existing cases pending against Bayer. Contact Jeffrey Glassman Injury Lawyers today to learn more about how our experienced attorneys can help if you or a loved one was hurt by Yaz.