Paragraph 8 reads: "In that paper, Teicher described six patients who were free of suicidal tendencies until they started on Prozac . His findings led him to predict that from 1.9 to 7.7 percent of Prozac users may be at risk for mania , obsession with suicide and dangerously violent behavior, "

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ANTIDEPRESSANT'S MAKER SUED - USERS CITE SERIOUS SIDE EFFECTS

Daily News of Los Angeles (CA) - August 16, 1990
Author: NATALIE ANGIER New York Times News Service

As reports mount that the nation's most widely prescribed antidepressant
drug may spark violent or suicidal behavior in a fraction of patients, lawyers and former users of the medication are banding together to file multimillion- dollar lawsuits against the drug's maker.

In the last three weeks, six lawsuits have been lodged against Eli Lilly & Co. of Indianapolis, who manufactures Prozac , seeking a total of more than $300 million in punitive and compensatory damages. Lawyers working on the cases say that they and other lawyers are planning to file dozens of suits in the next few weeks.

Although the specifics vary from case to case, the plaintiffs of all six suits generally charge the maker of Prozac with failure to have tested the
drug properly before introducing it on the market in 1987.

The suits also contend that Eli Lilly was "grossly negligent" for not warning doctors strongly and clearly enough that the antidepressant may sometimes set off aggressive, violent or suicidal behavior.

The lawyers maintain that while their clients were taking Prozac , they became far more hostile, despairing and uncontrollable than they had ever been before, committing extreme acts of self-mutilation, attempting suicide and endangering their families.

The lawyers attribute the violence to the psychiatric medication. They say that by presenting its product as relatively safe and free of significant side effects, Eli Lilly has made claims that are "shocking, absurd and totally misleading," said Leonard L. Finz, who heads a New York firm specializing in product liability cases.

All lawyers are relying on a report published in the American Journal of Psychiatry in February by Dr. Martin H. Teicher and his colleagues at Harvard Medical School and McLean Hospital.

In that paper, Teicher described six patients who were free of suicidal tendencies until they started on Prozac . His findings led him to predict that from 1.9 to 7.7 percent of Prozac users may be at risk for mania , obsession with suicide and dangerously violent behavior.

Spokesmen for Eli Lilly, while refusing to discuss the details of any cases under litigation, insist that Prozac was well-tested before being
marketed, and that it is remarkably safe.

"Certainly our product was adequately tested," said Edward West, director of corporate communications. "Laboratory testing began in 1976. More than 11,000 people participated in clinical trials.

"To date, more than 2 million patients worldwide have been treated with Prozac . Our experience with Prozac does not show a cause-and-effect relationship between it and suicidal thoughts or acts. Our safety track record has been well-established."

In the last few months, the Food and Drug Administration has received about 10,000 reports from doctors, pharmacists and others of adverse reactions to Prozac . But Dr. Paul Leber, director of the division of neuropharmacological drug products at the agency, said that the vast majority of reported side effects, like agitation or insomnia, are relatively mild and are included on the list of warnings that accompany the drug's packaging.

Of more severe reactions, he said it was hard to prove a cause-and-effect relationship.

"The trouble is that most of the symptoms described, like violence or suicidal tendencies, are symptoms well known to accompany depression," Leber said. "To date, we don't see anything about this drug that is associated with an increased risk" of violence or suicidal tendencies.

Leber and other experts note that, Prozac notwithstanding, depressed patients are at strong risk of suicide. They said that no single treatment for depression was completely effective and that a certain fraction of patients receiving Prozac or any other medication would be expected to fail to respond to the treatment and thus to continue being at risk for suicide.

"Ten percent of people with lifelong depressive illnesses probably will kill themselves," said Leber.

Medical experts are mixed in their response to the recent lawsuits against Prozac . On one hand, psychiatrists and other doctors say that many of the latest complaints are exaggerated and misleading.

They insist that Prozac is an extremely valuable drug for treating depression.
Caption: Box
Box: PROZAC 'S SIDE EFFECTS: 2 VIEWS
Edition: Valley
Section: NEWS
Page: N4
Index Terms: PROZAC; MEDICINE ; DEPRESSION ; HEALTH ; MENTAL ILLNESS ; ELI LILLY ; LAWSUIT ; SAFETY
Record Number: 9002120732
Copyright (c) 1990 Daily News of Los Angeles
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ANTIDEPRESSANT'S MAKER SUED - USERS CITE SERIOUS SIDE EFFECTS