Personal Injury Law

Should Television Ads for Chantix Be Required to State That Its Side Effects are the Subject of an FDA ?Black Box??

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 warning ? hence the name.

The U.S. Food and Drug Administration announced this past July that it is requiring manufacturers to put a Boxed Warning on the prescribing information for the stop-smoking drugs Chantix (varenicline) and Zyban (bupropion). The warning highlights the risk of serious mental health events including changes in behavior, depressed mood, hostility, and suicidal thoughts when taking these drugs.

It seems that if the dangers of Chantix are of such magnitude, potential customers should be advised of the dangers in a way that will get their attention immediately. Undoubtedly Pfizer, the manufacturer of Chantix, and its advertising agency, know that people usually tune out the disclaimers. Even if they?re still paying attention, viewers would certainly pay more attention to the warnings if they knew how seriously the FDA took the dangers. Waiting for Chantix users to eventually see the black box warning in the package insert seems to be a bad-faith tactic.

The FDA has been following reports of suicide and bizarre behavior in people taking Chantix. The FAA bans use of the drug by pilots, and the FDA warns people not to operate heavy machinery while using the drug. The FDA?s concerns about Zyban are more recent.

The FDA reports from earlier this year involving suicide and Chantix and Zyban are : 98 completed suicides in Chantix users; 14 completed suicides in Zyban users; 188 attempted suicides in Chantix users; 17 attempted suicides in Zyban users.

Meanwhile, our previous blog about e-cigarettes has received some comments. Some seem to have strong opinions in favor of them, particularly noting how much less dangerous they are than smoking cigarettes. Others see a government-industry conspiracy in the e-cigarette bans. As time goes on e-cigarettes can be expected to become more familiar to more people, and the debate could heat up.

Full post as published by Legal Blog on September 11, 2009 (boomark / email).