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Monitoring of high-risk medications unchanged despite FDA warnings
Date:1/12/2010

PORTLAND, Ore. A new study concludes that many doctors appear to have largely ignored a Food and Drug Administration warning to screen users of new antipsychotic drugs for high blood sugar and cholesterol, which poses risks to their health and raises questions about the efficacy of warning protocols in general.

The research analyzed about 109,000 Medicaid patients taking "second generation" antipsychotic drugs, which can cause increases in blood sugar, cholesterol and significant weight gain, as well as other symptoms significantly raising the risk of diabetes. It was done by health researchers from Oregon, Colorado, Georgia and Missouri, and just published in the Archives of General Psychiatry.

It found that most doctors never changed their level of baseline screening for blood sugar and cholesterol, despite a warning in 2003 from the FDA and two other organizations that these antipsychotic drugs could raise the risk of diabetes in a patient population that already was at higher risk for this disease.

"The existing baseline screening and ongoing monitoring of glucose and lipid levels in these patients was already pretty low, and the FDA warning really had no impact in changing that," said Daniel Hartung, an assistant professor of pharmacy instruction in the College of Pharmacy at Oregon State University.

"The side effects that can be caused by these new types of antipsychotic medications, some of which were first approved in the 1990s, are not trivial," Hartung said. "Increases in blood sugar, cholesterol and body weight can lead to diabetes in some cases, and this patient group already has a problem with diabetes that's almost twice that of the general population."

By 2003, Hartung said, enough evidence of these problems had accumulated that the FDA, along with the American Diabetes Association and the American Psychiatric Association, issued formal statements and warnings about the issue, and recommended
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Contact: Daniel Hartung
hartungd@ohsu.edu
503-494-4720
Oregon State University
Source:Eurekalert

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