Thursday, June 9, 2011

FDA Receiving New Information on Chantix Cases


It was recently reported that Pfizer failed to properly send hundreds of adverse event reports involving psychiatric problems with Chantix to the FDA for years, leading to an underestimation of the impact of Chantix side effects by the FDA. Included among the unreported problems were 150 Chantix-related suicides that date back to 2007. One of the most high profile cases of the severe effects that may be caused by Chantix is that of Carter Albrecht. Albrecht was a guitarist and keyboardist with the band Edie Brickell & the New Bohemians. He died September 3, 2007 after being shot in the head by a neighbor as he tried to kick in his door.

Although Chantix is an effective anti-smoking aid, it has also been called one of the most dangerous drugs on the market. It has some severe psychological side effects that may manifest in users, including but not limited to increased aggression, depression, behavioral changes, suicide attempts, and rage. It also has physical side effects such as seizures, heart rhythm disturbances, diabetes, vision disturbances, muscle disorders, and loss of consciousness. In an 18-month period, nearly 300 Chantix suicides were reported to the FDA.  As of January of 2011, Pfizer still maintained that their method of development and marketing in regards to Chantix was appropriate.


FDA warnings about using Chantix as part of nicotine withdrawal and recovery therapy begin with a 2008 advisory to health care professionals to be alert to and monitor for changes in mood and behavior in people taking Chantix. On July 1, 2009, it required Chantix to carry the most severe safety warning, the black box label. Dangerous Chantix side effects include: anxiety, nervousness, tension, depressed mood, unusual behaviors, thinking about suicide and attempted suicide. Following the startling reports and conflicting information given by Pfizer to the FDA, lawsuits have begun to emerge against the pharmaceutical manufacturer in droves. Although there is, as of yet, no way of knowing what kind of settlements plaintiffs are looking at from their Chantix lawsuits, the Chantix case can be compared to similar lawsuits involving major pharmaceutical companies. In many of these cases, plaintiffs received substantial settlements before trials even took place.

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