Stanford Medicine Newsletter Updates For the Local Community

Off-label drugs require more study



Stanford researchers are questioning a common practice of prescribing drugs for nonapproved uses, saying that some of these drugs need more scientific scrutiny.

Many doctors prescribe drugs to treat conditions for which they’re not approved, a practice known as off-label prescribing. But some widely used off-label drugs, particularly antidepres-sants and antipsychotics, are in urgent need of more scientific study, researchers concluded. They identified 14 medications most in need of study for their off-label uses.

“Off-label prescribing means that we’re venturing into uncharted territory where we lack the usual level of evidence presented to the FDA that tells us these drugs are safe and effective,” said Randall Stafford, MD, PhD, an associate professor with the Stanford Prevention Research Center. “This list of priority drugs might be a start for confronting the problem of off-label use with limited evidence.”

To determine which drugs were most in need of additional research, Stafford and his col-leagues called on a panel of nine experts from the FDA, the health insurance industry, the phar-maceutical industry and academia. The panel used three factors to prioritize which drugs should appear on the list: frequency of use, safety and cost.

At the top of the list was quetiapine (brand name Seroquel), an antipsychotic approved by the FDA in 1997 for treating schizophrenia. Rounding out the top five were warfarin, escitalopram, risperidone and montelukast.

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