Since the FDA Requires Corrective Language in TV Ad for Birth Control MedicationYaz, Why Not for Chantix as Well?
In a recent blog, we wondered why a television advertisement for the stop-smoking drug Chantix contained an exhaustive list of side-effects yet did not disclose that the drug was subject to a U.S. Food and Drug Administration (F.D.A.) black box warning. By virtue of this omission, a viewer might easily underestimate the seriousness of the televised side-effects. We honestly thought that Pfizer, the drugs manufacturer, would so tenaciously fight against mentioning the existence of a black box warning that its inclusion in an ad was not a realistic possibility. But shortly after this blog (maybe we are a bit behind), we viewed a television ad for the most popular birth control medication in the U.S., Yaz, that began, You may see some Yaz commercials that were not clear. The F.D.A. wants us to correct a few points in those ads. The Chantix "black box"warning was based on postmarketing reports of changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, hostility, agitation, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide in patients with and without preexisting psychiatric disease. The FDA has also warned that motor vehicle crashes, near-miss accidents, and other unintentional injuries have occurred in patients taking Chantix (varenicline). In some cases, patients reported somnolence, dizziness, loss of consciousness, or difficulty concentrating, potentially resulting in impairment. People should be cautious when driving, operating heavy machinery, or engaging in other potentially hazardous activities until they know how varenicline will affect them. The Yazadvertising campaign is costing Bayer Healthcare Pharmaceuticals, the manufacturer of Yaz, 20 million dollars. For the next six years Bayer is to submit all Yaz ads for federal screening before they appear. Considering that Yaz is the best-selling oral contraception pill in the United States, with sales in 2008 of about $616 million or about 18 percent market share, $20 million over 6 years seems well worth the cost to Bayer. The corrective advertising campaign is part of the settlement of a lawsuit filed by 27 state attorneys general against Bayer for false advertising. The corrective ad points out the errors in previous ads and warns that nobody should take Yaz hoping that it will also cure pimples or premenstrual syndrome. The companys earlier ads violated federal laws against promoting the unapproved uses of a drug. Yaz is approved for the psychological problem premenstrual dysphoric disorder, which is not the same thing as the much more common and far less severe PMS. One of the commercials cited by the F.D.A. has the song Were Not Gonna Take It by Twisted Sister playing in the background, with a series of young fashionably dressed women kicked away or punctured floating signs with labels like irritability and feeling anxious. A voiceover promoted Yaz as having benefits like the ability to maintain clear skin. The other commercial, set to the tune Goodbye to You by the Veronicas, shows a variety of women next to balloons marked headaches, acne and feeling anxious which float away. While blood clots (deep vein thrombosis (DVT) and pulmonary emboli (PE)) are a risk associated with all forms of birth control, the risk of blood clot problems with Yaz and its predecessor Yasmin are not the same as all other types of available birth control pills. When compared to women who were using no oral contraceptives, researchers found that users who took drospirenone, the progestin contained in both Yaz and Yasmin, had a 6.3 times greater risk of blood clots. By comparison, women who used birth control pills containing levonorgestrel had the lowest risk, with only a nearly 4 times increase over women taking no birth control. Our firm handled a case for the widower of a woman who was taking Yasmin who died from undiagnosed pulmonary emboli and deep vein thrombosis. Although our case was predicated upon medical malpractice, one of our theories was that inasmuch as Yasmin is a risk factor for DVT and PE, the fact that the patient was taking Yasmin made it more likely that these conditions were causing her symptoms and should have been considered by the doctor in making a diagnosis. We settled the case for $1,000,000.00. With the increasing awareness of thefrequency of adverseevents regarding Chantix and the black box prominently displayed on the drugs label, the strongest warning that can be placed on a prescription medication, it seems perfectly reasonable to require Chantix television commercials to convey the same seriousness as the products label. The ability of the F.D.A. to requireBayer to explicitly refer to the F.D.A.'s mandate to clear up past misleading ads for Yaz shows that the F.D.A. has the teeth to force the issue on Chantix ads if it is pushed hard enough to do so. The personal injury lawyers at Levine & Slavit have decades of experience handling personal injury claims. For 50 years spanning 3 generations, we have obtained results for satisfied clients. Contact the personal injury lawyers at Levine & Slavit for their help. We have offices in Manhattan and Long Island, handling cases in New York City, the Bronx, Brooklyn, Queens and surrounding areas. To learn more, watch our videos.
