FDA Issues Public Health Advisory on Chantix, Which May Become the Subject of Product Liability Suits

The U.S. Food and Drug Administration (FDA) on February 1, 2008, issued a Public Health Advisory to alert health care providers, patients, and caregivers to new safety warnings concerning Chantix (varenicline), a prescription medication used to help patients stop smoking.

Serious neuropsychiatric symptoms have occurred in patients taking Chantix. These symptoms include changes in behavior, agitation, depressed mood, suicidal ideation, and attempted and completed suicide. Chantix has been suggested as being a possibly significant contributing factor to the bizarre and tragic death of musician Carter Albrecht on September 5, 2007.

The FDA action adds credibility to the belief that Chantix is a dangerous product and may spur attorneys reviewing potential cases to institute litigation. The FDA is issuing this Alert to highlight important revisions to the WARNINGS and PRECAUTIONS sections of the full prescribing information for Chantix regarding serious neuropsychiatric symptoms.

Til now, only in the extreme fine print of the original box insert is it mentioned that rare psychotic and suicidal behavior are possible side effects of Chantix. The possibility of such side effects are not mentioned in large-print, pharmacy handouts given to users of the drug that warn of nausea, changes in dreaming, constipation, gas, and vomiting with the use of Chantix.

The FDA alert notes that while some patients may have experienced these types of symptoms and events as a result of nicotine withdrawal, some patients taking Chantix who experienced serious neuropsychiatric symptoms and events had not yet discontinued smoking. In most cases, neuropsychiatric symptoms developed during Chantix treatment, but in others, symptoms developed following withdrawal of Chantix therapy.

On November 20, 2007, FDA issued an Early Communication to the public and health care providers that the agency was evaluating post-marketing adverse event reports on Chantix related to changes in behavior, agitation, depressed mood, suicidal ideation, and actual suicidal behavior. As the agency’s review of the adverse event reports proceeds, it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.

As a result, FDA has requested that Pfizer, the manufacturer of Chantix, elevate the prominence of this safety information to the warnings and precautions section of the Chantix prescribing information, or labeling. In addition, FDA is working with Pfizer to finalize a Medication Guide for patients.

Chantix was approved by FDA in May 2006 as a smoking cessation drug. Chantix acts at sites in the brain affected by nicotine and may help those who wish to stop smoking by providing some nicotine effects to ease the withdrawal symptoms and by blocking the effects of nicotine from cigarettes if users resume smoking.

In the Public Health Advisory and a Health Care Professional Sheet that was also issued today, FDA emphasized the following safety information for patients, caregivers, and health care professionals: Patients should tell their health care provider about any history of psychiatric illness prior to starting Chantix. Chantix may cause worsening of current psychiatric illness even if it is currently under control. It may also cause an old psychiatric illness to reoccur. FDA notes that patients with these illnesses were not included in the studies conducted for the drug’s approval.

Health care professionals, patients, patients’ families, and caregivers should be alert to and monitor for changes in mood and behavior in patients treated with Chantix. Symptoms may include anxiety, nervousness, tension, depressed mood, unusual behaviors and thinking about or attempting suicide. In most cases, neuropsychiatric symptoms developed during Chantix treatment, but in others, symptoms developed following withdrawal of varenicline therapy. Patients should immediately report changes in mood and behavior to their doctor. Vivid, unusual, or strange dreams may occur while taking Chantix. Patients taking Chantix may experience impairment of the ability to drive or operate heavy machinery.

The FDA will continue to update health care professionals with new information from FDA’s continuing review or if new information is received on Chantix and serious neuropsychiatric symptoms. The FDA may consider requesting further revisions to the labeling or taking other regulatory action as the agency’s continuing reviews and conclusions warrant.

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