Chantix (varenicline) was approved in the United States by the FDA in
2006 as a prescription medication to help people quit smoking. The drug works
by reducing the positive feelings that come from cigarettes, blocking the
receptors in the brain commonly stimulated by nicotine. However, the impact of
the drug on the brain has resulted in a number of reports from users who
experienced sudden, unusually aggressive behavior, thoughts of self-harm and in extreme cases, Chantix suicide. Growing concerns over the drug have led to an ongoing investigation
into the Chantix side
effects in the United States. The FDA indicated that their review of data
indicates it is “increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.”This data may help a victim and Chantix lawyer regarding their odds of being granted compensation from the drug maker as a result of these psychological side effects.
About a year after being on the market,
reports began emerging about patients exhibiting strange and dangerous behavior
while on the smoking cessation drug. For instance, a Dallas
musician on Chantix was behaving aggressively and abusively and was killed
while attempting to kick in the door of a girlfriend’s neighbor.
The FDA has received a number of other adverse event reports and issued information on the potential risks, mandating a medication guide be provided to patients with each refill. While some reported psychiatric problems could have been the result of nicotine withdrawal, the FDA noted that many problems occurred while Chantix users were still smoking.
The findings heavily contradict those of an FDA-funded study announced in an October 24 Chantix drug safety communication. The FDA’s epidemiological studies failed to find any link between Chantix and dangerous psychiatric side effects.However, researchers who conducted the latest study point out that the FDA studies only looked for events that led to hospitalization. They noted that suicides, depression, aggression and even many assaults do not necessarily result in hospitalization, and thus were missed by the FDA study. Pfizer has responded to these studies, saying that using the adverse event reports is flawed because they are spontaneous and often do not contain important medical information and cannot establish a causal relationship between Chantix and suicidal thoughts, behavior or depression.In a recent study researchers looked at the FDA’s own adverse event reports on smoking cessation products and found that Chantix accounts for 90% of all reports of suicidal behavior and depression by people taking smoking cessation products.
The FDA has received a number of other adverse event reports and issued information on the potential risks, mandating a medication guide be provided to patients with each refill. While some reported psychiatric problems could have been the result of nicotine withdrawal, the FDA noted that many problems occurred while Chantix users were still smoking.
The findings heavily contradict those of an FDA-funded study announced in an October 24 Chantix drug safety communication. The FDA’s epidemiological studies failed to find any link between Chantix and dangerous psychiatric side effects.However, researchers who conducted the latest study point out that the FDA studies only looked for events that led to hospitalization. They noted that suicides, depression, aggression and even many assaults do not necessarily result in hospitalization, and thus were missed by the FDA study. Pfizer has responded to these studies, saying that using the adverse event reports is flawed because they are spontaneous and often do not contain important medical information and cannot establish a causal relationship between Chantix and suicidal thoughts, behavior or depression.In a recent study researchers looked at the FDA’s own adverse event reports on smoking cessation products and found that Chantix accounts for 90% of all reports of suicidal behavior and depression by people taking smoking cessation products.
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