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Clinical & Research News
Published Online: 7 November 2003

Canada Requires Diabetes Risk Label

Publication: Psychiatric News
Volume 38, Number 21
https://doi.org/10.1176/pn.38.21.0037a
The makers of atypical antipsychotic medications have been directed by Health Canada—the Canadian equivalent of the U.S. Department of Health and Human Services—to include updated information on hyperglycemia and diabetes on the labels of their antipsychotics. The move follows a similar order by the U.S. Food and Drug Administration (FDA) in September (Psychiatric News, October 17).
“This revised labeling will help ensure clinicians consider the risk for diabetes among all patients with severe mental illness, regardless of medication choice,” said Barry Jones, M.D., a clinical research physician at Lilly Canada, which markets the antipsychotic olanzapine (Zyprexa). Lilly disclosed the HealthCanada order in an October 16 press release. It was also Lilly that disclosed the FDA’s action.
“This will shift the focus of clinicians to what truly matters, choosing the most effective medication to address patients’ core psychiatric illness,” Jones said in a prepared statement.
Along with labeling for olanzapine, labels for risperidone (Janssen’s Risperdal), quetiapine (AstraZeneca’s Seroquel), and clozapine (Novartis’s Clozaril) will all carry the new warning language. Labels will also state that “appropriate clinical monitoring is advisable in diabetic patients and in patients with risk factors for the development of diabetes mellitus.” ▪

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Psychiatric News
Volume 38 • Number 21 • November 7, 2003
Pages: 37

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Published online: 7 November 2003
Published in print: November 7, 2003

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