The FDA’s public actions with regard to Yaz and Yasmin have centered on correcting the misleading advertising of the drug’s manufacturers. Yasmin has been approved for the U.S. market since 2001 and Yaz since 2006. However, in that short time the FDA has twice had to admonish the drugs’ manufacturers and demand that they cease their misleading marketing campaigns.
What Was Misleading About the Yasmin Advertisements that Resulted in a July 2003 FDA Letter?
Berlex Laboratories, the manufacturer of Yasmin in 2003, ran a 60 second TV commercial that marketed Yasmin directly to consumers. The commercial was called “Goodbye Kiss” and, according to the FDA, misled the public by implying unfounded clinical superiority over other birth control pills and minimizing the serious risks that Yasmin presented. The FDA was primarily concerned with two things. First, the unfounded claim of superiority and second the minimization of the potential harm caused by drospirenone, a progestin not found in other birth control pills at that time. Drospirenone has been linked to hyperkalemia, or an increase in potassium, that can result in heart problems and serious health problems. Accordingly, the FDA ordered Berlex to immediately discontinue the “Goodbye Kiss” ad and any similar advertisements that it was running.
What was Misleading about the Yaz Birth Control Commercials That Resulted in an October 2008 FDA Letter?
Five years later, Bayer Healthcare Pharmaceuticals was similarly admonished by the FDA. By 2008, Bayer was manufacturing both Yasmin and Yaz birth control pills. Both pills continue to contain drospirenone as an active ingredient.
In 2008, Bayer was actively marketing Yaz directly to potential patients with two 60 second TV commercials called “Balloons” and “Not Gonna Take It.” The commercials were concerning to the FDA for three reasons: (1) they broadened the approved uses for the drug and marketed the drug for uses that were not FDA approved; (2) they embellished the effectiveness of Yaz; and (3) they minimized the serious risks associated with Yaz. Specifically, the FDA was concerned that consumers might mistakenly believe that Yaz was approved for the treatment of PMS and mild acne, two conditions for which the FDA has not approved the drug. Further, the risks of hyperkalemia were understated, as they were in the 2003 advertisement put out by the previous manufacturer.
The FDA classified these advertising violations as serious and requested that they immediately be pulled from the airwaves. Bayer also had to submit a plan to make sure that all future advertising is truthful.
False advertising is always unfair to consumers and in the case of drug marketing it can also be very dangerous. Many women could potentially be hurt by the advertisements that were shown because they may have taken the drug based only on the misleading information provided and without full knowledge of the serious side effects associated with Yaz and Yasmin.
Women who have been hurt by Yaz or Yasmin should immediately contact a pharmaceutical litigation attorney who can assist them with their claims.