Warning on Suicide in Prozac Use Is Sought

Patients and doctors should get a stern warning about the risk of suicidal impulses for those taking Prozac, the nation's best-selling antidepressant, a health group said today.

The evidence linking Prozac "to suicidal ideation is alarming and strongly indicates the need for caution in the use of this medication," the Public Citizen Health Research Group said in a petition to the Food and Drug Administration.

The petition by the nonprofit group asks that a statement appear on Prozac's label to warn about a risk of suicidal thoughts and to advise patients to consider telling friends and relatives to monitor their behavior.

The warning would say that "a small minority of persons" taking Prozac "have experienced intense, violent, suicidal thoughts, agitation and impulsivity after starting treatment with the drug," and that whether the symptoms were coincidental or caused by the drug was under investigation.

Prozac's label already lists "suicidal ideation" as a possible side effect.

The drug agency had no comment on the petition. But Prozac's maker, Eli Lilly and Company of , in Indianapolis, said no new warning was needed.

"Their position is utterly without merit," said Edward West, a company spokesman. "The approved labeling for Prozac is consistent with current medical and scientific information, and no additional warnings are needed."

Prozac has been prescribed for more than 3.5 million people worldwide. The drug quickly became a best seller after receiving approval from the drug agency in February 1988.

Doctors attribute its popularity to its effectiveness, relatively mild side effects and low risk of injury or death from overdose compared with similar drugs.

But its market share has been shrinking with the filing of a number of lawsuits asserting that the drug is linked to violent behavior, including suicidal and homicidal impulses.

As many as 75 civil suits against Lilly have asserted that Prozac prompted some people to take suicidal or homicidal actions, the company said.

In addition, defendants in about 20 criminal cases have pleaded insanity based on their having taken Prozac.

All 10 of the criminal cases that have gone to a jury have resulted in convictions and rejection of the Prozac insanity defense, Mr. West said.

None of the civil cases have gone to trial and four have recently been dismissed as groundless, he said.

"We will pursue every one of the cases to the courtroom and settle none," he said. "The medical facts supporting this drug are very, very clear."