Zyprexa News

Zyprexa warning issued outside of the U.S.

-April 15, 2005

In Canada, the United Kingdom and in Europe, psychiatrists have received "Dear Healthcare Professional" letters by Zyprexa manufacturer Eli Lilly and Co., warning of cardiac and respiratory depression. In the U.S., however, doctors have received no such warnings.

The letters were sent last year, requested by regulatory authorities in Canada and Europe and signed by Zyprexa's manufacturer. Dated September 28, 2004, European clinicians were alerted to eight fatal adverse events, among 29 spontaneously reported adverse events that were linked to the use of Zyprexa IM. The European equivalent to the U.S. FDA, called the European Medications Evaluation Agency, the agency requested Eli Lilly send the Zyprexa warning letter.

The Canadian health ministry, called Health Canada, also requested Zyprexa warning letters. Dated September 7, 2004, the Zyprexa letter noted that 29 of the 49 adverse events were classified as "serious". Despite these Zyprexa warnings, American physicians have received no warning letters resembling the European and Canadian requested safety precautions.

According to European psychiatrists who have received "Dear Healthcare Professional" letters, the Zyprexa safety warning information should be made available to American clinicians. One American psychiatrist, Michael Allen, agrees, saying the failure to issue Zyprexa warnings in the U.S. is indicative of the FDA's postmarketing oversight of drug safety.

Allen was among the first to alert American doctors of the Zyprexa risks through an article in Emergency Psychiatry , which is the newsletter of the American Association of Emergency Psychiatrists. Because of the potentially fatal cardiovascular risks associated with Zyprexa IM, in addition to the aggressive marketing directed at American physicians, Allen is concerned patients are at risk for suffering serious adverse events.

American and European psychiatrists who spoke with Psychiatric News agreed Zyprexa IM cannot be exclusively blamed for fatal adverse events, but European psychiatrists speaking with the journal questioned why the FDA and Lilly had chosen not to inform American physicians about Zyprexa adverse events as European and Canadian clinicians had been. Clear risks, according to Robert Kerwin, a professor of clinical neuropharmacology at the Institute of Psychiatry in London, are associated with accumulating doses of Zyprexa IM in high risk patients and in combination with other medications, which American physicians should be warned about.

Allen is concerned the failure to issue Zyprexa warnings in the U.S. reflects a pattern of minimizing side effects associated with Zyprexa that goes back to concerns about weight gain and metabolic effects in the oral formulation but could be much more serious in the IM form. FDA actions are being closely watched in recent months following the recall announcements of two arthritis painkillers.

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