Advertisements on television and online fail to adequately warn Yaz users of serious side effects
In March of 2006, the U.S. Food & Drug Administration (FDA) approved YAZ 3mg drospirenone / 20 mctg ethinyl estradiol, a new monophasic oral contraceptive and the first pill to combine ethinyl estradiol with the innovative progestin drospirenone. The drug was manufactured by Berlex, Inc., a U.S. affiliate of Schering AG, Germany.
In October 2006, the FDA approved a new indication for Yaz, allowing its use for the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who choose to use an oral contraceptive as their method of contraception. This was followed by an FDA approval in January 2007 for a new indication for Yaz to treat moderate acne. This made Yaz the first and only contraceptive approved by the FDA for three distinct indications.
However, the FDA issued a warning letter to the makers of Yaz in October 2008, taking them to task for misleading information in television and web site advertisements. According to the 2008 letter, television advertisements misleadingly broadened the drug’s indications, overstated the product’s efficacy and minimized serious risks associated with the use of the drug.
According to the FDA letter, the minimization of risk is “particularly troubling as some of the risks being conveyed are serious, even life-threatening.” The letter goes on to say that the advertisements end up “misleadingly suggesting that YAZ is safer than has been demonstrated by substantial evidence or substantial clinical experience.”
Bayer began running corrective ads in January 2009.
But later in 2009, the FDA issued another warning letter to Bayer, raising concerns about online advertising through sponsored links on search engines. The company was again charged with making misleading claims as to the efficacy of Yaz, while failing to communicate any risk information associated with the drug’s use.
By the summer of 2009, individual lawsuits had been filed by women claiming injury as a result of using Yaz. Injury reports included deep vein thrombosis (DVT), pulmonary edema, cerebrovascular accident, myocardial infarction and death.