FDA Approves Drug to Treat Obsessive-Compulsive Disorder

The Food and Drug Administration has given final approval to a drug to treat obsessive-compulsive disorder, a mental illness thought to afflict at least one in 40 Americans, officials said Thursday.

FDA spokeswoman Eva Kemper said that the agency gave CIBA-Geigy Corp. of Summit, N. J., permission late last week to market clomipramine for use by people whose lives are seriously disrupted by obsessive-compulsive disorder.

Kemper said that she did not know how many of the estimated 5 million Americans with the mental disorder--marked by compulsive, repetitive acts like hand washing or floor scrubbing--might benefit from the drug.

Clomipramine, sold under the trade name Anafranil, has been available on a special case-by-case basis to U.S. patients since June, 1988. It is used in Europe to treat some patients with depression, Kemper said.

The drug should be used in obsessive-compulsive disorder cases only when treatments like behavior modification have failed, Kemper said, noting that about 1.5% of the people who took the drug for a year suffered from seizures. Other side effects include dry mouth, drowsiness, constipation, increased appetite and impotence, she said.

David Catlett, a spokesman for CIBA-Geigy, said he could not disclose how much clomipramine would cost or when it would be widely available. The company plans to hold a news conference Tuesday in New York to release marketing details.

Dr. Michael Jenike, an associate professor of psychiatry at Harvard Medical School, said that about 80% to 90% of the obsessive-compulsive patients he has seen require medication such as clomipramine.

Jenike estimates that about 85% of people experience “some benefit” from the drug, a success rate he termed “quite remarkable.” About 50% of the patients report their symptoms are much better after taking the drug, he said.