Chantix Side Effects Examined by FDA for Skin Reactions and Accidents

The anti-smoking drug Chantix, which was previously linked to an increased risk of suicide and suicidal behavior, was listed on a report released Thursday by the FDA of medications they are currently investigating for potential signals of new serious risks.

Chantix (varenicline tartrate) is one of 19 drugs or classes of medications identified by the FDA that showed potential signs of safety issues in the Adverse Event Reporting System (AERS) between October 2008 and December 2008.

Side effects of Chantix are being examined for a possible increased risk of angiodema, serious skin reactions, visual impairment and accidental injury. The FDA indicates that they are evaluating these issues to determine whether there is any need for regulatory action, such as stronger warnings.

Chantix, which is manufactured by Pfizer, was approved by the FDA in May 2006 and quickly showed signs of becoming a potential blockbuster medication. Early last year, sales slowed substantially after Chantix side effects were linked to a high number of suicides, suicide attempts and other reports of unusual aggressive behavior.

A number of Chantix lawsuits have been filed in state and federal courts throughout the United States alleging that Pfizer failed to adequately research or warn about the psychiatric effect the drug has on the brain. Last year, Pfizer updated the warnings about potential Chantix suicide problems several times after the FDA began investigating adverse event reports.

The potential safety issues identified by the FDA this week focus on a different set of potential health concerns.

According to the FDA statement, there have been reports of angiodema from Chantix, which is a rapid swelling that occurs beneath the skin, as opposed to on the surface. The swelling can develop very quickly, and can pose a medical emergency as airway obstruction and suffocation can occur.

The FDA also indicates that other serious skin reactions have been reported, which likely include reports of Stevens-Johnson syndrome from Chantix. Stevens-Johnson syndrome is a condition where the skin burns from the inside out, which can be caused by several different medications. It is a life-threatening condition that can lead to disfigurement, blindness and organ failure.

The Chantix Stevens-Johnson syndrome problems first surfaced in an independent report from the Institute for Safe Medicine Practices early last year. That same report also identified a potential increased risk of accidents on Chantix, which the FDA now indicates they are reviewing.

The FDA has received a number of reports of serious accidents and falls among users of Chantix, which could impact an individual’s alertness or motor control. In response to the Chantix accident problems, last May the Federal Aviation Administration (FAA) issued a Chantix ban for all pilots and air traffic controllers and the Federal Motor Carrier Safety Administration (FMCSA) indicated that those taking the drug should not qualify for a commercial motor vehicle license.

Although the FDA indicates that they are investigating these potential safety issues, it does not mean that they have concluded that there is a causal relationship between Chantix side effects and the risk identified. The FDA indicates that they are continuing to evaluate these potential Chantix problems to determine whether any steps need to be taken to protect the public.