Despite the many serious dangers associated with the drug, Yaz was America’s number one selling oral contraceptive in 2008. According to the New York Times, Bayer (manufacturer of Yaz/Yasmin) made approximately $616 million dollars domestically and $1.8 billion dollars in global sales off those products. These staggering numbers demonstrate why Bayer must not have been concerned in late 2008, when the FDA cited two Yaz commercials for deceptive advertising. As a result of the FDA’s warnings, Bayer had to spend about $20 million dollars to run corrective ads. That number certainly seems to be only a minor setback given the incredible profit they have made with Yaz/Yasmin.
Yaz/Yasmin is a once daily oral contraceptive. Although they are two separate drugs, Yaz and Yasmin are almost identical in chemical composition. Yasmin was introduced onto the market in 2001, receiving FDA approval in May of that year. Yaz received FDA approval in 2006. Both Yaz and Yasmin contain a synthetic progesterone called drsp (drospirenone). Drospirenone increases the user’s potassium level. This increased potassium level can lead to hyperkalemia (abnormal potassium level in the bloodstream). Hyperkalemia can cause arrhythmia (potentially fatal heart rhythms) and also increases the risk of developing gall bladder disease. In fact, the FDA has received information indicating that many of the deaths in women who were taking Yaz resulted from increased potassium levels.
Other serious side effects associated with Yaz/Yasmin include heart and cardiovascular problems, strokes, deep vein thrombosis (DVT), thromobophlebitis (vein inflammation from a blood clot), and pulmonary embolism (blood clot in the lungs). The British Medical Journal released two studies showing that when compared with other contraceptives, Yaz and Yasmin are more likely to cause blood clots. In fact, the study reports that Yaz/Yasmin users are 6.3 times more likely to suffer blood clots. The study attributes this elevated risk to the presence of drsp (drospirenone). As a result of these dangerous side effects, Public Citizen, a consumer advocacy group, placed Yaz/Yasmin on its “Do Not Use” list.
Although Yaz’s primary purpose is to prevent pregnancy, Bayer also claims it treats symptoms of PMDD (premenstrual dysphoric disorder) and moderate acne. Beginning in March 2006, Bayer ran a large marketing campaign that targeted women in their twenties. The slogan of the campaign was “beyond birth control”. The campaign also consisted of two commercials, which created an enthusiastic scene set to lively rock songs: “We’re Not Gonna Take It” and “Goodbye to You”. These advertisements falsely suggested Yaz is approved for relieving premenstrual syndrome (PMS). The commercials suggested that women’s PMS symptoms would be suppressed although that had not been proven. Yaz was only FDA approved for treatment of symptoms of premenstrual dysphoric disorder (PMDD), which differs from premenstrual syndrome. PMDD can cause women to have tension, constant anger, and anxiety.
After examining Bayer’s marketing campaign, the FDA issued them a warning letter on October 3, 2008. The FDA’s warning letter cited the two Yaz commercials for deceptive advertising. The letter reprimanded Bayer for overstating and exaggerating the benefits of the birth control pill and also for deemphasizing the serious side effects associated with its use. The FDA said, “these violations are concerning from a public health perspective because they encourage the use of Yaz in circumstances other than those in which the drug has been approved.” According to the FDA, the commercials’ images were fast paced and the music was distracting, particularly at points where the drug’s serious side effects were being described. In summary, the TV advertisements deceptively stretched the indication of the drug.
In an effort to reconcile with the FDA, Bayer began running corrective advertisements in early 2009. The TV ads were part of an agreement that Bayer reached with the FDA and 27 state attorneys general. These ads were a positive step moving forward. However, making the assumption that Bayer has taken more responsibility for its’ actions would be a mistake. In fact, the FDA recently issued an additional warning to Bayer regarding Yaz/Yasmin. In August 2009, the FDA warned them about poor quality control at a German plant that produces drospirenone used in Yaz. Bayer continues to lack concern for health and safety.
Bayer’s deceptive advertisements for its birth control pills, Yaz and Yasmin, should serve as two important lessons for consumers. First, not everything you see and hear on television is true. Second, consumers need to make smarter health decisions because pharmaceutical companies like Bayer are more likely to choose profit over public health.