January 6, 2010 (Updated January 7, 2010) — When it comes to monitoring metabolic effects of second-
generation antipsychotics (SGAs), it appears that physicians are not heeding recommendations by government or
leading professional organizations. New research suggests that less than one-third of patients treated with these
medications, which can have significant and serious adverse metabolic effects, undergo blood glucose or lipid
“We studied a 3 state population of Medicaid recipients and found diabetes and dyslipidemia screening among
patients receiving SGAs was low and did not increase following the FDA [Food and Drug Administration] warnings or
recommendations from the American Diabetes and American Psychiatric Associations, which called for increased
metabolic monitoring of patients taking these agents,” study investigator Elaine H. Morrato, DrPH, MPH, University
of Colorado, Denver, told Medscape Psychiatry.
The retrospective analysis is published in the January issue of Archives of General Psychiatry.
Prompted by research showing a strong link between SGAs and an increased risk for hyperglycemia and diabetes,
starting in 2003 the FDA began requiring warning labels on SGAs, including olanzapine, risperidone, quetiapine,
ziprasidone, clozapine and aripriprazole.
“In some cases the hyperglycemia was extreme and associated with ketoacidosis, hyperosmolar coma, or death,”
the study authors note.
As part of the FDA initiative, manufacturers of SGAs were required to send letters to neuropsychiatric health care
professionals informing them of the warnings and advising them of the need for glucose testing in patients with a
diagnosis of diabetes, risk factors for diabetes, or symptoms of hyperglycemia.
At the same time, the American Diabetes Association and the American Psychiatric Association published a
consensus statement describing the metabolic risks associated with atypical antipsychotics and specifying a
monitoring protocol for all patients receiving these medications.
Low Rates of Metabolic Testing
To assess the impact of these warnings and recommendations on glucose and lipid testing and drug selection of
SGAs, the investigators examined laboratory claims data from the Medicaid population of 3 states — California,
Missouri, and Oregon — between 2002 and 2005.
They compared rates of metabolic monitoring between a group of 109,451 patients receiving SGAs and a control
group of 203,527 patients who began taking albuterol but who did not receive antipsychotic medication. Rates were
also compared before and after the FDA warning.
Baseline glucose and lipid testing rates for SGA-treated patients were low at 27% and 10%, respectively. However,
the FDA warning was not associated with an increase in glucose testing among SGA-treated patients, and lipid
testing rates only increased by a marginal 1.7%.
FROM: Medscape Medical News
BY: Caroline Cassels