FDA Warnings to the Makers of Yaz and Yasmin

May 22, 2009

Misleading Yasmin and Yaz Ads and Commercials the Subject of FDA Warning Letters

Yaz and Yasmin are two of the most popular and best-selling birth control pills in the United States. However, the Food & Drug Administration (FDA) found that several ads and commercials within the Yaz and Yasmin marketing campaigns used misleading advertising which minimized the side effects involved with taking these birth control pills and portrayed them as safer than they have been proven to be.

The FDA sent the manufacturers three warning letters for downplaying the risks of Yaz and overstating the benefits of the birth control pill.

Misleading Yasmin and Yaz Ads and Commercials the Subject of FDA Warning Letters

The first FDA warning letter came in 2003. The 2003 FDA Yasmin warning letter found that the Yasmin ad “misleadingly represents or suggests that Yasmin is safer than has been demonstrated by substantial evidence or substantial clinical experience. The FDA also noted that “women and their healthcare providers must weigh Yasmin’s additional health risks when considering Yasmin over [oral contraceptives] without drospirenone.”


Yaz Warning Letter: Yaz Commercial “Over-promise[d] the Benefits and Minimize[d] the Risks”

The second warning letter came in October 2008, and again the FDA found that Yaz commercials “encourage[d] use of YAZ in circumstances other than those in which the drug has been approved, over-promise[d] the benefits and minimize[d] the risks associated with YAZ.” The 2008 FDA Yaz warning letter found that the Yaz commercials made it seem as though the drug could treat PMS and any level of acne, when in reality Yaz was only approved to treat PMDD (premenstrual dysphoric disorder) and moderate acne. As a result, the maker’s of Yaz had to run a $20 million advertising campaign to clarify the use and potential side effects of Yaz.


Yaz Warning Letter: Yaz Ad “Fail[ed] to Communicate Any Risk Information”

The third warning letter came in 2009 when the FDA found that Bayer’s advertisements for Yaz “fail[ed] to communicate any risk information” about use of the birth control pill. The 2009 FDA Yaz warning letter again found that Bayer was overstating the benefits of Yaz and the problems Yaz was designed to treat.


Injured by Yaz or Yasmin? Free and Confidential Consultation

Our Yaz lawyers represent people from across the country who were injured by Yaz or Yasmin birth control medication. If you or someone you know was injured by these medications, you may have a legal right to pursue financial compensation for your injuries or other damages. Fill out the form to the right or call (866) 981-4800 for a free confidential consultation concerning your possible Yaz lawsuit.