In 2009 Bayer Was Required To Correct Advertising Information About Benefits And Risks Of Its YAZ Birth Control Pill

Similarly, In 2003 The FDA Sent A Warning Letter To Berlex Laboratories Regarding Yasmin Ads That Regulators Said Minimized Safety Issues

YAZ has become the best-selling oral contraception pill in the U.S. according to IMS Health, with about 18 percent of the market share; its 2008 sales revenue was about $616 million. YAZ is manufactured and marketed by Bayer Healthcare Pharmaceuticals.

From early February 2009 to late July 2009, however, the Food and Drug Administration (FDA) and the attorneys general of 27 states have required Bayer to run a $20 million advertising campaign for the purpose of correcting previous YAZ marketing statements. In addition, for the next six years Bayer must submit all YAZ ads to the FDA screening before they appear.

Essentially, Bayer's earlier YAZ ads allegedly overstated the pill's ability to improve women’s moods and clear up acne, while playing down its potential serious side effect risks. The FDA first took action against Bayer as concerns these earlier misleading YAZ ads in October 2008 when the agency sent a warning letter to Bayer saying that two television ads overstated the drug’s benefits while understating its risks.

Let's start with that part of the 2008 FDA warning letter that says Bayer overstated the benefits of YAZ. The FDA asserted that Bayer's earlier ads tended to give consumers the impression that YAZ was a drug for acne and general mood problems. When the FDA initially approved YAZ in 2006 it was approved as a birth control pill that has a side benefit in treating a very specific mood-related psychological problem called "premenstrual dysphoric disorder". In 2007 the agency approved another side benefit of YAZ, which is improving moderate acne. However, YAZ has never been approved for simple acne and general mood problems; therefore, Bayer’s YAZ ads violated federal laws that prohibit a drug company from promoting the unapproved uses of a drug, the FDA said in its October 2008 YAZ warning letter.

Next, we consider the potential health risks of YAZ which -- according to the 27 state attorneys general and the FDA -- Bayer allegedly minimized or understated. YAZ contains drospirenone (DRSP), a relatively new progestin that can cause serious side effects involving the formation of dangerous blood clots in some patients. In particular, the use of YAZ has been associated with pulmonary embolisms (PE) and deep vein thrombosis (DVT) as well as strokes, heart attacks, and sudden death.

There have also been case reports suggesting an increased risk associated with YAZ, Yasmin, and Ocella of gallbladder disease, resulting in the removal surgery cholecystectomy, as well as pancreatitis.

Interestingly, a birth control pill that closely resembles to YAZ, Yasmin -- both contain contain ethinyl estradiol and the new "fourth generation" progestin drospirenone (DRSP) -- had been the subject of a similar FDA warning letter back in 2003. This Yasmin FDA warning letter was sent to Berlex Laboratories; Bayer acquired Berlex as part of a deal in 2006, and Bayer now markets Yasmin. According to IMS Health, last year Yasmin had sales of about $382 million, or about 11 percent of the U.S. market.

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