Bayer is in trouble over advertising for its <"http://www.yourlawyer.com/topics/overview/YAZ">Yasmin birth control pill. According to a report from the Financial Times, a British regulatory authority says Bayer has promoted Yasmin for uses that have not received regulatory approval.
The Prescription Medicines Code of Practice Authority has faulted one Yasmin ad Bayer ran in a British medical journal that touted the drug as a treatment for premenstrual syndrome and acne. According to the authority, the ad in question “was misleading, prejudiced patient safety and brought the pharmaceutical industry into disrepute.” The authority also said the ad downplayed Yasmin side effects.
The Prescription Medicines Code of Practice Authority is the pharmaceutical industry’s self-regulatory body in Great Britain.
According to the Financial Times, the ad ran with the headline: “Contraception and more.” In the copy, Bayer stated: â€œYasmin. Itâ€™s for more women than you might imagine.â€ It said the drug â€œhas also been shown to have a beneficial effect vs baseline on acne, fluid retention, hirsutism and premenstrual symptoms.â€
According to the Financial Times, the disciplinary action does not carry a fine or other sanction.
Yasmin, along with a similar contraceptive sold by Bayer called Yaz, are low-estrogen pills made with a type of progestin called drospirenone. As weâ€™ve reported previously, drospirenone is known to carry some health risks not seen with other forms of the hormone. Most notably, it can increase the levels of potassium in the blood, which can lead to a disorder called hyperkalemia in high-risk patients. This condition may result in potentially serious heart and health problems, including fatal cardiac arrhythmias. High potassium levels are especially dangerous for people who are obese, or who have diabetes or high blood pressure. Several studies have indicated that women taking these types of birth control pills may face a higher risk of blood clots.
In the U.S., Yasmin and Yaz have been named in more than 6,000 lawsuits, many of which are consolidated in a multidistrict litigation in federal court in the Southern District in Illinois. The lawsuits claim Yaz and Yasmin caused plaintiffs to suffer blood clots, heart attacks, stroke, gallbladder disease and other Yaz side effects.
The European disciplinary action is not the first time regulators have questioned Bayer’s advertising for one of its drospirenone contraceptives. In October 2008, the U.S. Food & Drug Administration (FDA) issued a warning letter to Bayer that cited two Yaz commercials for making deceptive claims. In a warning letter, the FDA faulted Bayer for overstating the benefits of Yaz and minimizing the drugâ€™s risk of dangerous side effects. Bayer quickly agreed to stop running the offending Yaz ads. The company also began running a â€œcorrective advertising campaignâ€ as a part of an agreement with the FDA and attorneys general in 27 states.
According to the Financial Times, the U.K.’s Medicine and Healthcare Products Regulatory Agency cited Bayer in 2009 for a claim that drospirenone â€œhas a positive effectâ€‰…â€‰on fluid retention,â€ which the agency said was not supported by adequate evidence.