Sunday, February 3, 2008
Chantix and Suicide
Anti-smoking pill joins the list—but is the risk real?
The U.S. Food and Drug Administration fired both barrels last week, announcing that a variety of anti-seizure medications—as well as the anti-smoking pill, Chantix—may increase the risk of suicidal thoughts in patients who take them. The FDA will require new label warnings for a total of 11 drugs used for epilepsy.
New label warnings are also in the works for Chantix, the nicotine cessation aid being widely used by people attempting to quit smoking cigarettes. In a public health advisory issued last Friday, the FDA declared it “increasing likely” that Chantix may be associated with psychiatric problems. A month earlier, the FDA had advised that Chantix users should be monitored for the onset of suicidal urges, but backed off from making a strict cause-and-effect connection.
The FDA reviewed clinical data on anti-epileptic medications, including Pfizer’s Neurontin and Ortho-MacNeil’s Topamax, and concluded that “patients who are currently taking or starting on any anti-epileptic drug should be closely monitored for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.” Topamax has shown additional promise as an anti-craving medication for alcoholism.
This follows on the heels of earlier warnings about increased suicide risk in adolescents taking SSRI antidepressants.
In the case of Chantix, the FDA’s Bob Rappaport, in a conference call with reporters, said the agency had “no definitive evidence there is a causal relationship here, they are just strongly appearing to be related.” Rappaport, quoted at WSJ.com, also said that “Chantix has proven to be effective in smokers motivated to quit,” and that the new warnings would help doctors and patients “make an informed decision regarding whether or not to use this product.”
A spokesman for Pfizer, quoted at Bloomberg.com, said that “no causal relationship has been established. There are some post-marketing reports and you cannot exclude those. We go by our scientific data, and from our clinical trial data we have not seen this.”
Discussions about a possible link between Chantix and suicide were fueled by the death last year of New Bohemians lead singer Carter Albrecht, who was shot while attempting to break into a house in Dallas. His girlfriend told authorities that his behavior had been erratic since he began taking Chantix in an effort to stop smoking.
In no case are the numbers of suicides linked to any of the drugs alarmingly high. The FDA study of epilepsy medications appears to demonstrate, as summed up by the San Francisco Chronicle’s Bernadette Tansey, “2.1 more people for every 1,000 on the medications exhibited suicidal thoughts or behavior, compared with every 1,000 on placebo.”
Note that the FDA is not discussing an increased risk of suicide, but rather an increased risk of suicidal thoughts or feelings. This is called “suicidal ideation.” The FDA usually refers to it as “suicidality.” Unlike an actual suicide attempt, suicidal ideation is the act of contemplating the act—a sort of “what if.” It is the difference, as a mental patient once put it, between buying the rope, and contemplating buying the rope
Persistent suicidal ideation is obviously not a desirable state of mind. But it does not downplay this behavior to note that it is, by nature, often fleeting and difficult to quantify. Moreover, the act of going cold turkey itself can cause heavily addicted people to feel temporarily suicidal—to ideate about killing themselves without killing themselves. These and other factors make it difficult to reach firm statistical conclusions about such risks.
For a Chantix user's point of view on the debate, visit www.stopsmokingcigs.com
Photo Credit: eNews 2.0