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The Roanoke Times (VA)
October 6, 1991
I HAVE just returned from Food and Drug Administration hearings on the medication Prozac. We had only a 30-day notice with which to organize and make arrangements to attend this meeting. We were pleased to be able to convince one-third of the panel of the need for a change in labeling.
Since 1987, at least 14,100 reports of adverse reactions from Prozac have been reported. Some 300 of these reports are deaths by suicide with another 200 attempted suicides.
Health professionals told the panel that the tragedies amounted only to anecdotes, not scientific evidence that Prozac sparked the violent behavior. I would like to know where the scientific evidence is that Prozac did not cause the violent behavior.
The National Mental Health Association stated that changing the current label without compelling scientific evidence was a particular concern, since it would discourage physicians from prescribing Prozac and like medications, and frighten patients from taking it.
I have always thought the FDA was there to protect the public. As the widow of a Prozac suicide victim, I cannot gather the scientific evidence needed, but I’m sure the FDA could have the drug companies at least research 300 suicides and find out the why of adverse reaction.
I don’t ask for a ban of the drug. I ask for a test that can determine who can safely take it. Don’t let the public play Russian Roulette with it.
Record Number: 9110070247