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HEALTH : Government Is Set to Approve Prozac for Bulimia Treatment

November 11, 1994|From Associated Press

NEW YORK — Prozac, praised as a wonder drug to treat depression and reviled by critics who say it causes violent and suicidal urges, is about to get approval for another high-profile affliction: the eating disorder bulimia.

Eli Lilly & Co., which introduced Prozac in 1987, said Thursday that the Food and Drug Administration has issued what is known as an approvable letter in support of using the drug for bulimics.

That is generally the final step before the FDA grants approval for a new drug or for a new use of an existing product, said Victoria Murphy, spokeswoman for the Indianapolis-based company.

Psychiatrists said Thursday that many doctors are already prescribing Prozac for bulimia.

Prozac, which costs about $75 a month for a once-a-day pill, is the world's biggest-selling antidepressant.

The drug was considered revolutionary when approved because, unlike its predecessors, overdoses weren't considered dangerous, and it didn't have persistent side effects such as dizziness, sleepiness and memory problems.

It has successfully weathered blistering criticism and a bevy of lawsuits starting in 1991, when some scientists and the Church of Scientology said it prompted homicidal and suicidal behavior.

Prozac's sales have soared about 40% this year, prompting industry analyst Neil Sweig of Ladenburg, Thalman & Co. to estimate they will reach $1.7 billion for 1994.

Lilly shares rose 37.5 cents Thursday to $64.75 on the New York Stock Exchange.

In March, Prozac was approved for treatment of obsessive-compulsive disorder, a condition in which a person has a sometimes uncontrollable need to perform rituals such as changing clothes or cleaning.

Ronald Nordmann, drug industry analyst for money manager Deerfield Management Inc., said current trends indicate that within a year, the drug could be the country's No. 1 seller, surpassing the ulcer drug Zantac, which had $1.9 billion in 1993 sales.

In announcing the likely approval, Lilly also announced a setback. The company said it has withdrawn its application for the obesity drug Lovan, which includes the same active ingredient as Prozac. The FDA wants all obesity drugs to undergo two-year human studies to make sure they work, and Lilly said such tests aren't worth it.

Some doctors now prescribe Prozac for obesity because it suppresses the appetite, though its cost has kept such use relatively low.

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