Safety, Efficacy For Off-Label Uses Of Prescription Drugs Questioned

Ruzanna Harutyunyan's picture

A new study published on Tuesday in the journal Pharmacotherapy lists 14 medications commonly prescribed for off-label uses that require additional testing to prove their safety and effectiveness for such uses, USA Today reports.

According to the study -- led by Randall Stafford, an associate professor of medicine at the Stanford Prevention Research Center -- although past research has "highlighted the substantial frequency of off-label drug use without good evidence, we have identified and prioritized specific drugs warranting attention" (Rubin, USA Today, 11/25).


Researchers identified the medications on the list based on their usage, marketing, amount of associated increased risk, price and newness to the market (Wang, "Health Blog," Wall Street Journal, 11/25). Antidepressants accounted for six of the medications on the list, and antipsychotics accounted for three, with the schizophrenia treatment Seroquel, manufactured by AstraZeneca, at the top of the list.

Stafford said, "It's not that these off-label uses are necessarily harmful or that these drugs don't work," but they require additional study. He added, "Clearly, for many of these off-label uses, the manufacturers are benefiting enormously, and in some cases I think one could argue that off-label use has allowed them to circumvent the regulatory process." Diedtra Henderson, a spokesperson for the Pharmaceutical Research and Manufacturers Association, said that member companies do not promote off-label uses of medications. She added, "This is an activity that our companies aren't allowed to do under FDA regulations" (USA Today, 11/25).

Reprinted with permission from You can view the entire Kaiser Daily Health Policy Report, search the archives, and sign up for email delivery at . The Kaiser Daily Health Policy Report is published for, a free service of The Henry J. Kaiser Family Foundation. © 2007 Advisory Board Company and Kaiser Family Foundation. All rights reserved.