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, bulimia.
Eli Lilly & Co. said this week the Food and Drug Administration has issued what's known as an approvable letter in support of using the drug for treating the eating disorder.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 company, which introduced Prozac in 1987.
Psychiatrists said Thursday that many doctors are already prescribing Prozac, the world's largest selling antidepressant, for bulimia.
"This will allow psychiatrists who are not specialists and (family) doctors to be more comfortable in the use of it," said Dr. James Hudson, an associate professor of psychiatry at Harvard Medical School who helped design some of the tests of the drug.
Bulimia, which afflicts about 1 million Americans a year, mostly young women, is a mental disorder in which the victims believe they are constantly overweight.
They binge on food, only to purge themselves of it by inducing vomiting, sometimes dozens of times per day. The vomiting can cause dangerous conditions that could ultimately lead to death.
Bulimics often have related conditions including depression and obsessive-compulsive disorders.
Prozac is designed to treat those by allowing the body to produce and keep adequate levels of a substance called serotonin, which regulates moods.
Prozac isn't helpful for all bulimics, but has been shown to be effective, especially when taken in conjunction with psychotherapy, said Dr. Peter Kramer, author of the best-seller "Listening to Prozac," which chronicled the drug's history and discussed its mood-altering characteristics.
"To think you can walk into a doctor's office and be given a pill and that is the end of it - that is very unlikely," he said.
Other antidepressant drugs are currently used to treat bulimia, but Prozac would be the first specifically authorized by the FDA for the condition.