Doctors Ignore FDA Warning to Screen Users for Antipsychotic drugs

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A study which was done by health researchers from Oregon, Colorado, Georgia and Missouri, and just published in the Archives of General Psychiatry released January 2010, concluded that many doctors have largely ignored a Food and Drug Administration (FDA) warning to screen users of new antipsychotic drugs for high blood sugar and cholesterol. Both of these medical conditions can be a very high risk to health. In addition it begins to raise questions about the efficacy of warnings.

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.

Researchers found that most doctors never changed their level of baseline screening for blood sugar and cholesterol, despite a strong warning in 2003 from the FDA and two other organizations that 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.

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"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."

These second-generation antipsychotic drugs known as olanzapine, aripiprazole and others, are extremely powerful medications and were originally developed for treatment of schizophrenia, Hartung said. They were originally prescribed only by psychiatrists, however their use has now expanded widely into treatment for problems such as bipolar disorder and less serious mental health problems such as depression and dementia. These powerful drugs are often administered by general practitioners.

"Part of the problem may be that simply sending doctors a letter about these issues, which come up every now and then with medications, is just not getting the job done," Hartung said. "With this group of medications, at least, it clearly wasn't effective, and it does raise questions about whether new approaches are needed. Part of the problem may also be people moving from one doctor to another, and inaccurate assumptions about testing being made."

Anyone taking these medications, Hartung said, may wish to discuss with their physicians what type of metabolic screening they’ve had, and consider glucose and lipid testing if it has not already been done if they are on these second-generation antipsychotic drugs since many doctors are ignoring the FDA warning.

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