Warnings About a Miracle Drug

By Anastasia Toufexis

A swift and sweeping popularity is often followed by a stinging backlash. That is as true for medical therapies as it is for hit TV series and fashionable restaurants. The latest example: Prozac, a drug taken to combat depression. Introduced in January 1988 and hailed as safer than competing medications, Prozac quickly surged to star status, thanks to skillful promotion by manufacturer Eli Lilly, glowing word of mouth among doctors and patients, and heavy media attention, including cover stories in Newsweek and New York. Sales are expected to top $700 million this year, making Prozac the leading antidepressant.

Now, though, Prozac is receiving some unfavorable publicity. Reports have surfaced that the drug can sometimes make users feel suicidal -- just the opposite of the desired effect. Prozac "survivor" groups, which help people who say they have had bad experiences with the drug, have been formed in New York, Indiana, Florida, Iowa and Kentucky. And last week a woman in New York State sued Eli Lilly for $150 million, claiming that Prozac had induced her to slash her wrists.

Despite the new concern, the evidence linking Prozac to suicidal behavior is tenuous and relies mostly on anecdotal histories. The most substantial report appeared last February in the American Journal of Psychiatry. In that study, Dr. Martin Teicher, a research psychiatrist at McLean Hospital in Belmont, Mass., documented the cases of six depressed patients who became obsessed with violent suicidal thoughts two to seven weeks after starting treatment with Prozac. Four tried to hurt or kill themselves. The compulsion subsided after the patients went off the drug.

But there were several confounding factors, as Teicher is quick to admit. Four of the patients were on other medications as well as Prozac. Five of the patients had contemplated suicide or attempted it at some point in their past. That raises the question of whether the preoccupation with self-destruction resulted from Prozac or from the depressive disease itself. Teicher suspects the drug in part because none of the patients were actively suicidal at the time they began therapy with Prozac. "Moreover," he observes, "the nature of their suicidal thoughts was qualitatively different than it had been in the past. While they were on medication it became an irresistible impulse."

Both Eli Lilly and the Food and Drug Administration point out that Prozac was extensively tested on more than 5,600 patients and that at least 2 million people worldwide have taken the drug. The FDA, which monitors reports of adverse reactions to drugs, sees no worrisome pattern to date. "Even if we got several hundred reports involving suicide and Prozac, we wouldn't be alarmed, given how many people use the drug and the nature of the disease," notes Dr. Paul Leber, director of the FDA's division of neuropharmacological drug products. "Depressed people commit suicide." Nonetheless, the agency is watching closely, and Eli Lilly revised its product literature in May to alert physicians to the suggested association with suicide. "But we emphasize that there is no reason to believe a cause-and-effect relationship exists," says company spokeswoman Marie Abbott.

There is no need for everyone to be scared away from Prozac, since it has proved safe and effective for many people. But some doctors fear that Prozac has been overprescribed. In the initial excitement after its introduction, the drug was given to patients to help them lose weight and stop smoking, despite a lack of solid evidence that it is effective for those purposes. The experience with Prozac underscores the truth about drugs in general: they all carry risks and should be used with care and restraint.

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With reporting by Andrew Purvis/New York