Evansville Courier, The (IN) August 2, 1991

FDA REJECTS REQUEST FOR BAN ON PROZAC \ Author: The Associated Press Edition: Final Section: Metro Page: C8 Dateline: WASHINGTON Estimated printed pages: 2

Article Text:

The Food and Drug Administration rejected Thursday a request by a group affiliated with the Church of Scientology that it ban the anti-depressant drug Prozac on grounds it makes people suicidal and violent.

The FDA released a letter to the Citizens Commission on Human Rights saying it had found no evidence for these claims or for the commission's additional claims that Prozac is addictive and causes movement disorders.

The FDA said it reviewed the evidence provided by the group along with data supplied by the drug's manufacturer, Eli Lilly and Co. of Indianapolis.

The group's petition cited cases of depressed patients being treated with Prozac who committed or attempted suicide.

The FDA said the data provided no way of determining the relative roles of the drug and the depression in causing the suicidal behavior.

''Depression itself is highly associated with suicide," the agency said.

It said clinical trials did not show any greater rate of suicide attempts among depressed patients on Prozac than among those being given placebos or treated with other anti-depressants.

Eli Lilly called the action a reaffirmation of the safety and effectiveness of the drug. It said the Citizens Commission on Human Rights was a Scientology front group engaged in "a dangerous deception."

''Scientology's disinformation is a menace to the public health as it attempts to frighten patients away from appropriate medical care and safe and effective medicine," Lilly said in a statement.

FDA said the drug's labels already note that violent behaviors have been reported among a small number of patients and that, in clinical trials, hostile behavior was observed at rates ranging from one in 100 to one in 1,000.

The commission said Prozac had been linked to murders, but the FDA said the small number of cases and the lack of detailed information made it impossible to draw conclusions from the data.

Prozac's labeling also says there have been rare instances in which movement disorders have been reported in association with the use of the drug.

The commission sought to show such instances have been more frequent. But the FDA said that in all but one case the diagnoses were incorrect or the patients were using other drugs that might have been the cause.

Copyright (c) 1991 Courier and Press

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