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Patients Can Switch Safely From Clozaril to Generic Clozapine: Presented at APA

By Paula Moyer

SAN FRANCISCO, CA -- May 22, 2003 -- Patients who have been taking the brand-name version of the antipsychotic medication clozapine (Clozaril) can be safely switched to generic clozapine, according to Jeffrey Stovall, MD.

"The switch worked better than we expected," said Dr. Stovall, assistant professor of psychiatry at the University of Massachusetts Medical School in Worcester, Massachusetts, United States, where he is a staff psychiatrist at the University of Massachusetts Memorial Community Health Center. "We saw no significant differences in patients' symptoms before and after the switch."

Dr. Stovall presented his and his colleagues' findings here at the 156^th Annual Meeting of the American Psychiatric Association. Since the patent has expired and generic clozapine has become available, the Massachusetts Department of Medical Assistance mandated that patients who were beneficiaries of this program take the generic rather than the brand-name formulation.

"Any time a generic becomes available for a brand-name drug, physicians are concerned about the switch to generic," Dr. Stovall said. Because clozapine is typically used in patients with treatment-resistant schizophrenia, physicians were particularly concerned about any loss of efficacy the switch could entail.

Therefore, he and his colleagues decided to measure the levels of clozapine and norclozapine before and after switching, as well as any changes in patients' clinical status. In order to avoid the potential for bias, the investigators funded the study only with internal resources and received no industry support for their research.

Patients received the same clozapine dose after switching, and psychiatrists could adjust doses at their discretion if necessary. The study involved 71 patients who had an average age of 43.15 ± 8.86 years.

The investigators saw no statistical difference in the mean percent change in patients' clozapine levels following the switch, nor in their clozapine plus norclozapine levels (P>0.5). Dr. Stovall also said that patients' clinical symptoms were similar before and after switching, and that he and his co-investigators documented no major adverse effects.

"We feel that this switch can be made safely without exacerbating patients' psychiatric illness," Dr. Stovall said. The switch can result in significant financial savings without compromising patient care, he said.

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