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July 25, 2012 / Admin

FDA Issues Warning Letter Over Alcohol Dependency Drug

For anyone whose life has been ruined by alcoholism, the chance to turn everything around with a shot in the arm must be appealing. Get an injection from your doctor and instantly repair every personal relationship that was destroyed by the disease. The appeal of such easy redemption is obvious, but it is also obviously a fantasy. The FDA has told one drug company that it cannot advertise that fantasy. Earlier this month, the Food and Drug Administration sent a warning letter to Alkermes, Inc., the makers of the alcohol-dependency drug Vivitrol. The drug is designed to decrease cravings for alcohol, but Alkermes has been advertising that it can do much more. The letter advised Alkermes that it had to stop distributing a DVD shown to potential Vivitrol users and a patient brochure because of exaggerated claims of efficacy. The DVD featured testimonials in which Vivitrol users said things such as this, from “Tina S.”:

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“The money was going towards alcohol and not the kids. . . .  With the drinking, DSS got involved. . . . Julie at the clinic, she suggested Vivitrol. . . .  Since I’ve been on the shot. . . .  I feel better about myself now that I’m sober.  I’ve got a little bit more respect from the kids and that I feel like a mother now. Physically I’m in better shape than I was. . . . Couldn’t even crawl out of bed and now I’m back to work. . . .  My life has changed so much in the past year.  I’ve gotten remarried.  We’re working on the house and everything’s going pretty good.”

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