Many docs off mark on off-label scripts

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Chicago Sun Times

HEALTH | 45% in study wrong about FDA's approval

BY MONIFA THOMAS Health Reporter/mjthomas@suntimes.com

Doctors often prescribe drugs "off-label" to treat conditions for which they're not approved.

But a new study suggests that some off-label prescribing may be driven by doctors' mistaken belief that certain drugs are actually approved by the federal Food and Drug Administration for such use.

Researchers at the University of Chicago and the University of Virginia asked 1,200 psychiatrists and primary care doctors to identify whether 14 common drugs were approved by the FDA for treatment of various illnesses.

The average doctor was wrong about the FDA approval status of 45 percent of the drugs he or she was asked about, according to the study, published in Pharmacoepidemiology and Drug Safety.

One example was the schizophrenia drug quetiapine. Nearly one in five doctors who said they prescribed the drug for dementia erroneously believed that it was FDA-approved for this purpose. In fact, at the time of the study, the FDA had issued a "black box" warning about an increased risk of death in elderly dementia patients who used quetiapine.

Study co-author Dr. G. Caleb Alexander said the results suggest that doctors need to have a better understanding of the science supporting certain off-label drug uses.

"Our findings highlight an urgent need for.....read more about docs off mark on off-label scripts