Study warns of ‘off-label’ use of antidepressants, antipsychotics
by Rita Rubin on Nov. 25, 2008, under Body, Nation/World
Among all the drugs prescribed to treat conditions for which they’re not approved, doctors and patients should be most concerned about antipsychotics and antidepressants, a study suggests Tuesday.
This “off-label” prescribing is a legal, common practice that is being questioned in some cases because of inadequate scientific evidence to support its safety and effectiveness.
“Although previous research has highlighted the substantial frequency of off-label drug use without good evidence, we have identified and prioritized specific drugs warranting attention,” the authors of the new study write in the journal Pharmacotherapy.
They list 14 drugs for which needed research into off-label use is most pressing. Three are antipsychotics, six are antidepressants. The researchers considered three factors in devising their list: the volume of off-label use with inadequate evidence, drug safety, and cost and market considerations.
“It’s not that these off-label uses are necessarily harmful or that these drugs don’t work,” said senior author Randall Stafford, associate professor of medicine at the Stanford Prevention Research Center. The problem, he said, is that no one can be certain, because needed studies haven’t been done.
The Food and Drug Administration requires companies to test their drugs only against conditions for which they’re seeking approval.
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CLOSER LOOK
The study suggests that research into “off-label” prescribing is most pressing for:
1. Quetiapine (Seroquel).
2. Warfarin (Coumadin).
3. Escitalopram (Lexapro).
4. Risperidone (Risperdal).
5. Montelukast (Singulair).
USA TODAY
