Two Prominent Smoking Aids to Require Depression Warnings

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Stock values have dropped as a result of a FDA decision to implement the need for safety warnings to be carried on ‘Chantix’ and ‘Zyban.’ The two drugs have been on the market for a number of years with the requirement requested of Pfizer, the creator of the drugs as a result of evidence that their side effects include depression and suicidal thoughts.

The agency’s strongest safety warning must now be carried on the packaging for the material. The news has hit the share price of the pharmaceutical firm by close to 1% of its real value.

The ‘Black Box’ warning has been necessitated by reports of the unusual behaviour possibly as a consequence of their use. A report and study must now be conducted by the pharmaceutical firm into these findings at the behest of the FDA. The report is expected to determine the extent of the side effects, with the drug alleged to have played a role in up to 37 suicides to date. More than 400 cases of suicidal behaviour have been allegedly linked in the reports, to the drugs. Although Pfizer had updated its packaging back in 2007 as a consequence of emerging information on the links, this ‘Black Box’ warning requirement is the strongest warning the FDA can request, and it will necessitate a broader change in the packaging.

The format for the required study is in the discussion stage between the two entities currently. The true incidence of psychiatric conditions as a result of usage of the drugs can best be determined by including patients who use the drugs with and without these side effects. It is anticipated that this is the process that will be followed in the study.

It is a matter of weighing up the benefits of the drug against the risk according to the FDA, “The risk of serious adverse events while taking these products must be weighed against the significant health benefits of quitting smoking,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.

Whereas according to the Doctor there may be risks, she pointed out that smoking is a dominating cause of death, and given the success of these products in getting people off cigarettes the pros and cons need to be taken on a patient by patient basis. The use of Chantix has already been banned for pilots as a result of evidence the drug can in some cases lead to blackouts. It acts not by replacing nicotine as is the case with the majority of smoking cessation aids out there but by diminishing the desire for nicotine itself.

$846 million worth of the drug was sold in 2008, these are the latest sales figures available, but they show a slight decline in sales more than likely related to the emerging evidence of the mentioned side effects. Pfizer stated that it has made the revised label warnings in agreement with the FDA. It claims that it is with immediacy making the information available to health care providers and patients.

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