The History of Yaz’s FDA Approval

Read a brief history of Yaz’s approval by the FDA and subsequent warnings about its health risks.

Yaz and FDA Approval


Pharmaceutical manufacturer Bayer produces Yaz, the birth control pill. This oral contraceptive relies on the synthetic hormone drospirenone. Yasmin is another drug that works in a similar manner. The FDA first approved Yasmin, made by Berlex, on November 18, 2004. In December of 2005 the FDA extended the review period of Yaz as an oral contraceptive until the first quarter of 2006.  In January of 2006 the FDA clarified the status of the Yaz PMDD application. On March 17, 2006 Yaz was approved as an oral contraceptive. The following October Yaz Acne was approved as an oral contraceptive as a treatment for Premenstrual Dysphoric Disorder (PMDD). The drug, despite the name, was not approved to treat acne until January 30, 2007.


Side Effects of Yaz


After its approval, Yaz was very popular. It was the most popular oral contraceptive in the United States at one point. Its popularity have fallen in recent years as tens of thousands of women have complained and reported severe side effects from Yaz ranging from blood clots, deep vein thrombosis (DVT), pulmonary embolism, strokes, kidney failure, and gall bladder infection and removal. These complaints have resulted in over 10,000 lawsuits and several warnings from the FDA.


Warnings from the FDA


The first warning over a contraceptive using drospirenone was issued to Berlex the maker of Yasmin in 2003. The FDA warned over the marketing practices of the drug (Read the FDA letter here).


Similar warnings would be issued to Bayer for its Yaz marketing in 2008 and 2009. (Click here for 2008 letter and here for 2009 letter). Every year the outcry against Yaz seemed to grow in intensity, although Yaz remains the fourth most popular birth control pill on the market.


Several troubling studies linking Yaz to blood clots and an assortment of blood clot related illnesses resulted in the FDA ordering a stronger warning label for drugs like Yaz and Yasmin. (Click here to read the stronger label.)


Many have been disappointed over the FDA’s failure to simply pull Yaz off the market. Bayer has faced allegations of improper drug marketing and being less than forthcoming with the FDA about blood clot risks.


If you, or you loved one, has taken Yaz and has suffered blood clots, DVT, Pulmonary embolism, strokes, kidney failure, gall bladder infection or removal, time may be limited to enforce your legal rights. Contact Yaz lawyers experienced in Yaz litigation as soon as possible.  The lawyers of Slater Slater Schulman LLP are here to help. Please call us to discuss your potential Yaz lawsuit at 1-800-251-6990 or fill out the form on the right of this page and someone from our office will contact you to discuss your case.

Leave a Reply


Anti-Spam Protection by WP-SpamFree

Follow Us on:

Contact Us

Privacy Policy

Please click here to view our privacy policy.