US regulators have sent a stern letter to Bayer saying that two television commercials for the oral contraceptive Yaz give a misleading impression of its benefits.
The US Food and Drug Administration says the two 60-second direct-to-consumer ads called Not Gonna Take it and Balloons overstate the efficacy of Yaz (drospirenone and ethinyl estradiol) minimise its risks and incorrectly suggests that the pill has been approved for treating pre-menstrual syndrome. Yaz is approved for premenstrual dysphoric disorder, a more serious condition.
The TV ads “misleadingly suggest that Yaz is approved to treat women with any severity of the symptoms presented, regardless of whether their symptoms are actually severe enough to constitute PMDD,” the FDA letter states. The first commercal, which is no longer broadcast, featured “energetic, euphoric, playful women” singing as they kick, punch and push balloons with words on them such as “irritability,” “moodiness” and “bloating”, symptoms which are common with PMS.
The second ad shows women releasing balloons labelled with the symptoms mentioned above as well as others such as headaches and acne. The FDA says that the commercial suggests “women are saying ‘goodbye’ to their symptoms and are now symptom-free, when such an elimination of symptoms has not been demonstrated by substantial evidence or substantial clinical experience”. Explaining its opposition to the ad, the FDA notes that Yaz is approved for treating moderate acne vulgarities, but the commercial suggests that the pill is able to treat acne of all severities.
The agency also criticises the fast-moving images and background music used when information is imparted about potential side effects. The FDA says these “complex presentations distract from and make it difficult for viewers to process and comprehend the important risks being conveyed. This is particularly troubling as some of the risks being conveyed are serious, even life-threatening”.
The warnings associated with the use of Yaz include venous and arterial thrombotic and thromboembolic events, such as myocardial infarction, thromboembolism, stroke, hepatic neoplasia, gallbladder disease and hypertension. Bayer says that it will now pull the remaining offending advert.
