The Food and Drug Administration has finally acted to dispel the suspicion that it unfortunately cast around the most effective medication for the treatment of tobacco addiction. Varenicline, which reduces withdrawal symptoms including craving and blocks the rewarding effect of tobacco, had for years been burdened unnecessarily with an FDA-required “black box warning.” The FDA warning was based not on scientific studies but on anecdotal reports that Varenicline could cause suicidal depression. The FDA repeatedly refused to change its position despite well-constructed studies that concluded there was insufficient evidence to justify the warning. In December of 2016, FDA removed the warning.
The FDA’s reversal is important because many doctors will not prescribe a medication that carries a black box warning. Additionally, many patients, especially those who struggle with depression, are unwilling to take a medication that allegedly makes people suicidal.
The FDA’s about-face is good news for people with alcohol and drug addiction. They are one of the few groups that continue to use tobacco at high rates. Even those in recovery have shortened life spans as a group because of their continued use of tobacco. Studies tell us that most of them want to quit. But tobacco addiction is at least as difficult to treat as other substance use disorders, and every useful intervention is welcome.
Perhaps we can now move to remove other obstacles – like the myth, supported by the recovery community as well as by some clinicians in addiction treatment, that recovery from alcohol and drugs is less likely if the person also tries to stop using tobacco. This is another area where the evidence is outweighed by irrational beliefs to the detriment of those struggling to recover.
It would be even better if the insurance industry stopped refusing to cover psychological treatment for tobacco addiction. The irony is that the enormous cost of treating the consequences of this addiction is borne by the same companies. I believe that the companies will eventually recognize that this coverage is in their interest as well as those of their customers. But who knows when.
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