Recently, a man and his daughter went missing for nearly two days. The wife and mother says that smoking cessation drug Chantix is to blame. Susan Marino says her husband, Michael, was taking Chantix to help him quit smoking. Michael—who was with their eight-year-old daughter, Lena—dropped Susan off at a doctor’s office last Thursday morning and never returned.
Police ultimately found Michael and Lena on Saturday morning off of Interstate-4 near Orlando, Florida. According to authorities, Michael appeared disoriented. Susan reported that the auto’s computer indicated that Michael had driven for 44 hours and 1,800 miles; he spent over $500 on gas. Lena was fine.
Although doctors are unclear about what occurred, Susan believes Michael’s disorientation is related to Chantix. Susan says Michael took Chantix for the past two weeks and that, a few days after he started Chantix, some of his co-workers reportedly said he started acting strange and didn’t seem like himself. The Chantix warning label states the drug might cause neuropsychiatric symptoms, including changes in behavior, agitation, depression, and suicidal behavior.
Michael was admitted to Physicians Regional Medical Center and after a variety of tests his wife reports no signs of an underlying medical problem such as a stroke, which is why she believes it is related to Chantix.
Meanwhile, the US Food and Drug Administration (FDA) recently approved the Medication Guide on Chantix and issued an alert to highlight changes to the “Warnings and Precautions” section of the full prescribing information regarding serious neuropsychiatric symptoms linked to Chantix. Symptoms include changes in behavior, agitation, depressed mood, suicidal ideation, and both attempted and completed suicide. Many consumer advocates, including the group Public Citizen, want the FDA to go further and highlight the Chantix suicide risk with a black box warning—the agency’s highest safety alert.
Despite this, health officials in the federal government are urging smokers to use Chantix as part of their efforts to stop smoking despite the drug’s association to suicidal thoughts and behavior. And, while the new smoking cessation guidelines, published by the US Public Health Service, do note the Chantix links with suicide and other psychiatric side effects, the Pfizer drug is promoted as the method most likely to help smokers wanting to quit. The new guidelines are creating controversy, not only because of the strong Chantix recommendation, but also because their lead author, Dr. Michael Fiore, has ties to Pfizer.
As FDA’s review of the problems with Chantix has continued, the FDA states it “appears increasingly likely that there is an association between Chantix and serious neuropsychiatric symptoms.” It was because of this that the FDA requested that Pfizer, the manufacturer of Chantix, elevate the prominence of this safety information.
In the US, 34 Chantix users have reportedly committed suicide. According to an FDA November 20 Early Communication, the agency said its preliminary assessment revealed many of the cases reflected new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment.