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 a FDA-mandated black box … Read the rest

Suffolk County Nation’s First County to Ban Electronic Cigarettes from Minors and From Public Indoor Spaces

On August 18, 2009, the Suffolk 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 … Read the rest

FDA Requires Boxed Warning on Serious Neuropsychiatric Events for Chantix and Zyban. Is a Ban Next?

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 … Read the rest

FDA Issues Public Health Advisory on Chantix, Which May Become the Subject of Product Liability Suits

The U.S. Food and Drug Administration (FDA) on February 1, 2008, issued a Public Health Advisory to alert health care providers, patients, and caregivers to new safety warnings concerning Chantix (varenicline), a prescription medication used to help patients stop smoking.

Serious neuropsychiatric symptoms have occurred in patients taking Chantix. These symptoms include changes in behavior, agitation, depressed mood, suicidal ideation, and attempted and completed suicide. Chantix has been suggested as being a possibly significant contributing factor to the bizarre and tragic death of musician Carter Albrecht on September 5, 2007.

The FDA action adds credibility to the belief that Chantix … Read the rest

“Stop-Smoking” Drug Chantix May Have Caused Psychotic and Suicidal Behavior Leading to Death of Musician

Concerns have surfaced that Chantix, the stop-smoking drug manufactured by Pfizer, may have led to musician Carter Albrecht’s bizarre and tragic death on September 5, 2007. That rare psychotic and suicidal behavior are possible side effects of Chantix is mentioned in extreme fine print of the original box insert. However, large-print, pharmacy handouts given to users of the drug warning of nausea, changes in dreaming, constipation, gas, and vomiting with the use of Chantix do not mention rare psychotic and suicidal behavior.

Albrecht was keyboard player from pop-music group Edie Brickell and the New Bohemians. Albrecht was also a singer, … Read the rest