Yaz For Acne and PMS
In October 2008, the Food and Drug Administration sent a warning letter to Bayer Pharmaceuticals, the manufacturer of Yaz, telling the company to stop airing a series of “misleading” TV commercials which overstated the effectiveness of the birth control pill at treating acne and PMS symptoms and downplayed the risk of the pill’s side effects.
Both Yaz and a similar brand of birth control, Yasmin, contain a unique hormone called drospirenone (DRSP). In addition to helping to prevent contraception, birth control pills with DRSP work as a diuretic to eliminate excess water from the body, which prevents bloating and weight gain during menstruation. DRSP also helps to block the hormones that can lead to acne.
The FDA’s warning letter criticized Bayer for marketing Yaz for conditions that it was not approved to treat. Specifically, the agency stated that the ads falsely implied that Yaz had been approved to treat the symptoms of PMS as well as more severe forms of acne.
The letter also faulted Bayer for failing to alert women of the risk of side effects they could face by using Yaz. Products such as Yaz, Yasmin and Ocella that contain DRSP are twice as likely to cause blood clots as other forms of prescription birth control pills. This increased blood clot risk could lead to a number of other serious conditions, including deep vein thrombosis, pulmonary embolism, heart attack or stroke.
Users of Yaz, Yasmin and Ocella have also experienced gallbladder or kidney problems. In some cases, these conditions required women to undergo gallbladder removal surgery in order to treat their symptoms.
Later in 2008, Bayer was forced to run a $20 million ad campaign in order to correct the misleading information about Yaz and to alert women of the side effects they could face by using the birth control pills.