By Hugh C. McBride
A smoking-cessation drug that experts believe could also help alcoholics kick their habit has come under increased scrutiny following reports that associated the medication with a range of physical conditions and mental health disorders.
Chantix, which is manufactured by Pfizer Inc., has been approved for use in the United States since May 2006. The drug (generic name: varenicline tartrate) has been sold in the European Union under the brand name "Champix" since September 2006.
The medication has been marketed as an aid for those who are attempting to quit smoking, and a 2007 study by the University of California at San Francisco raised hopes that it could also be of use in the fight against alcoholism. But a public health advisory issued by the U.S. Food and Drug Administration cautions that the drug may have debilitating - and even deadly - side effects.
A PROMISING BEGINNING
According to information provided by a variety of sources (including the product's manufacturer and the Mayo Clinic), Chantix differs from most tobacco-cessation drugs in the way it interacts with the body.
Most products in this field function by providing former smokers with controlled low-level doses of dopamine, the pleasure-related hormone the brain releases when it is stimulated by nicotine. Chantix provides a similar dopamine boost, but it also blocks the brain's nicotine receptors, so that individuals who "slip up" and have a smoke are less likely to get the pleasurable result they have come to expect.
Though some experts were effusive in their praise of Chantix's potential, an analysis posted on the Mayo Clinic website cautioned that, within a year of quitting with help from Chantix, between 77 and 86 percent of clinical trial participants had resumed smoking.
The FDA announced its approval of the drug with a May 11, 2006 press release that quoted Dr. Steven Galson, director of the agency's Center for Drug Evaluation and Research. "Chantix therapy has proven to be effective in smokers motivated to quit," Galson said, "and [it] will provide another tool for physicians to use for the millions of smokers who want to quit."
The FDA's approval followed a "priority review" in which the standard 10-month analysis period was reduced to six months. The FDA said the drug merited this accelerated review status because of its "significant potential benefit to public health" and the positive results of six clinical trials that involved 3,659 chronic cigarette smokers.
THE DEATH OF A MUSICIAN
Reports of problems associated with Chantix began to receive national media attention in September 2007, when individuals close to the late singer Carter Albrecht implicated his use of the drug as contributing to the bizarre circumstances that led to his death.
Albrecht, a keyboard player who had performed with Edie Brickell and New Bohemians before embarking on a solo career, began taking the drug along with his girlfriend, Ryann Rathbone. Within a week, Rathbone told ABC News, the couple began experiencing "nightmare kind of, hallucination kind of dreams where you don't know if it's real or not."
On Sept. 3, after taking Chantix and downing a few cocktails, Albrecht flew into a rage, screaming and hitting Rathbone before running out of their house. While attempting to kick down the door to a neighbor's house, Albrecht was killed by a "warning shot" fired from inside the house he was trying to break into.
"I really believe it was the [Chantix]," Rathbone told the Dallas Morning News two days after Albrecht's death. "He would have never been abusive toward me, never, ever. He and I had a very peaceful, loving relationship."
THE GOVERNMENT INTERVENES
Albrecht and Rathbone weren't the only people to experience "Chantix dreams" or other extreme reactions to the drug. Though unusual dreams and sleep disturbances were among the side effects listed by Pfizer - along with nausea, constipation, vomiting, and flatulence - studies and anecdotal reports indicated that the drug posed a much greater risk than was originally thought.
According to the nonprofit Institute for Safe Medication Practices, between Chantix's debut in May 2006 and the end of 2007, the FDA received 227 reports of suicidal acts, thoughts, or behaviors; 397 cases of possible psychosis; and 525 reports of hostility or aggression in individuals who were prescribed the drug. The ISMP also noted that use of the drug has been associated with traffic accidents, vision problems, abnormal heart rhythm, seizures, and skin reactions.
Less than two years after it granted approval for Chantix, the FDA issued a public health advisory about the drug. The Feb. 1, 2008 statement advised that "it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms."
The advisory stated that a review of adverse action reports indicated that "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. ... Symptoms may include anxiety, nervousness, tension, depressed mood, unusual behaviors and thinking about or attempting suicide."
A little over three months after the FDA's public health advisory was released, Chantix received the thumbs-down from two other federal agencies. Citing concerns about the drug's role in automobile accidents involving drivers who had been prescribed the drug, the Federal Aviation Administration banned its use by pilots and air traffic controllers. A day after the FAA's announcement, the Federal Motor Carrier Safety Administration told medical examiners that individuals who use Chantix should not be approved to receive commercial motor vehicle licenses.
One other arm of the federal government has also weighed in on Chantix: The U.S. military has banned flight and missile crews from taking the drug, and Pentagon officials told The Los Angeles Times that additional restrictions may be issued pending further study.
AN UNCERTAIN FUTURE
In the wake of the studies, anecdotal reports, and federal moratoriums on approved use, Pfizer has continued to defend its drug.
In a press release that was posted in response to the FDA's health advisory, the corporation's chief medical officer was quoted as describing Chantix as "a real breakthrough medicine." Noting that Pfizer had complied with the FDA's request to enhance the health warnings it provides to physicians and Chantix users, Dr. Joe Feczko said, "We hope that today's labeling change will further facilitate the important dialogue that should always occur between patients and their doctors when considering any prescription medication."
Pfizer officials aren't the only ones who are cautioning against abandoning Chantix. Dr. Nieca Goldberg, a cardiologist with New York University, told Fox News that the potential for negative side effects is no reason to ban a drug. "One of the biggest messages we need to get out there is that all medications have side effects," Goldberg said. "But patients need to ... talk with their doctors so that they can better understand why or why not a particular medication has been prescribed to them and whether or not they should continue taking that medication."
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