FDA Places Black Box Warnings On Smoking Cessation Drugs

The proof obtained from varied trials undertaken by Pfizer for Chantix has shown greater probability of success rate in cessation of the smoking habit. The antagonistic nature of Chantix or Champix is known to inhibit craving for nicotine, causes decreased smoking pleasure and other tobacco derived produce. There are a reported three million people in America that consume Chantix.

Several patients on Chantix have undergone precarious and adverse side effects comprising of most common ones like nauseous feeling, headaches, insomnia and recurrent bad or unpleasant dreams, while many others feel extremely worked up, depressed or show strange withdrawal behaviour patterns. Chantix side effects also include the inception of mental illness like lunacy, manic behaviour, bipolarity, delirium or schizophrenia. Chantix may cause a relapse of past mental illness. Chantix users have also been reported to tend to have suicidal tendencies, tried or committed suicide.

Fatal accidents inclusive of vehicle accidents have been reported with Chantix users. FDA has been keeping tracks of the number of fatalities in these users and has disallowed the use of the drug in pilots and has issued a warning to those consumers to ward off using bulky machinery when on the drug. The Institute of Safe Medication Practices has declared that the Chantix users in comparison to others smoking cessation drugs had the maximum cases of dangerous side effects. Many who go off Chantix experience panic attacks, feeling quite miserable, many of whom are advised to gradually wean off the drug rather than a sudden stoppage.

Zyban, an anti-depressant marketed as Wellbutrin has bupropion as the key component also used to quit smoking. Though, Wellbutrin does mention the warning of suicidal tendencies, the warning label does not extend to Zyban users who use to stop smoking.

Distressing reports presented to the FDA show 98 suicide fatalities and 188 tried suicide attempts in Chantix consumers. There were in comparison 14 suicide fatalities and 17 tried suicide attempts in Zyban users. Though these reports have not been delved in detail, with chances of duplication of reports and the reports have not been certainly known to be drug related side effects.

The lower number of reports of Zyban users doesn’t essentially mean the drug is safe in comparison to Chantix because there are lot more people who use Chantix than Zyban. FDA has issued black box warnings on both the drugs cautioning that doctors should mitigate the use of the drug by adopting a far observant attitude and dynamically supervise the patients.

According to the FDA, both Zyban and Pfizer will need to conduct clinical trials in this regard, an initiative which has been already started by Pfizer on the drugs effect on schizophrenics. Many users of antibiotics, acne drugs, epilepsy and anti-depressant drugs are also known to exhibit suicidal behaviour. Though, no suicide cases in nicotine patch users have been reported.

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