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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 a

Yesterday morning an advertisement for smoking cessation drug Chantix came on my television. The ad featured a man extolling how much better his life is now that Chantix (and support, slips in the ad) has helped him kick his smoking habit. Then an announcer came on and read, for what seemed like an extraordinary time for the disclaimers usually heard on drug commercials, a litany of side-effects and warnings. These warnings included suicidal thoughts, personality changes, and skin rashes. The announcer did not state, however, that many of the side-effects announced are the subject of an FDA-mandated black box warning.

A black box warning is a type of warning that appears on the package insert for prescription drugs that may cause serious adverse effects. A black border usually surrounds the text of the

On August 18, 2009, the Sullolk County Legislature voted to ban electronic cigarettes from public indoor spaces where 'traditional forms of smoking are already disallowed,' but allows adults to use the devices anywhere cigarette smoking is permitted. The bill also bans the sale of e-cigarettes to anyone under the age of 19. The bill has been described as the first of its kind in the nation. It cites the 'unknown' amount of nicotine in the battery-operated devices as presenting a 'significant risk of rapid addiction or overdose.' Suffolk's new law is expected to take effect 90 days after the New York Secretary of State signs the bill in Albany. Electronic cigarettes, also called e-cigarettes, are battery-operated devices that generally contain cartridges filled with nicotine, flavor and other chemicals. The electronic cigarette turns nicotine, which is highly addictive, and other chemicals into a vapor that is inhaled by the user. They deliver nicotine without burni

The U.S. Food and Drug Administration (FDA) announced on July 1, 2009, that it is requiring manufacturers to put a Boxed Warning on the prescribing information for the smoking cessation drugs Chantix (varenicline) and Zyban (bupropion) and to update the Medication Guides for patients that further discuss the risk of mental health events when using these products. The warning will highlight the risk of serious mental health events including changes in behavior, depressed mood, hostility, and suicidal ideation and behaviors when taking these drugs. The FDA has received additional information bolstering the suggestion of a possible association between both varenicline and bupropion and serious neuropsychiatric symptoms, in both patients with and those without previous history of psychiatric illness. The FDA first informed the public about the possibility of serious neuropsychiatric symptoms with Tagged with: Pharmaceuticals Dangerous Products Lawyer Chantix