Study Calls for Greater Scrutiny of 'Off-Label' Drug Use

Nov. 25 -- MONDAY, Nov. 24 (HealthDay News) -- It's called "off-label" prescribing, and it's the common practice of doctors prescribing a drug to treat a disease or condition that's different from the one studied by federal regulators that led to the drug's approval in the first place.

Despite the scope of the practice, there's often little evidence that using a drug for an unapproved purpose is always beneficial or safe, a new study found.

The study by American researchers has identified 14 widely prescribed medications that they think need additional study to see how effective and safe they are for off-label use. Many of the drugs are antidepressants and antipsychotics.

"Off-label prescribing is not based on the same level of evidence as on-label prescribing," said study lead researcher Surrey Walton, an assistant professor of pharmacy administration at the University of Illinois at Chicago.

Most patients aren't aware that once a drug is approved for one use, any doctor can prescribe it for any other use, Walton explained. Doctors may turn to a drug for off-label use, because studies or evidence suggest that it might benefit a patient with a disease or condition that was not studied when U.S. Food and Drug Administration regulators approved the drug in the first place.

"Typically, drugs have to pass a number of safety tests, Walton said. "But once they are put on the market, because they have received approval for an on-label indication, they can be used off-label," he said.

The new report was published in the Nov. 24 issue of the journal Pharmacotherapy.

Antidepressants and antipsychotics are the most prominent classes of drugs on the list, which specifically targets medicines that have high levels of off-label use without good scientific backing.

Topping the list is the antipsychotic quetiapine (Seroquel), which is approved by the FDA as a treatment for schizophrenia. The team noted that off-label use of this drug accounted for 76 percent of its prescriptions.