Researchers call for more scrutiny of off-label prescribing

12/1/2008

NEW YORK Many doctors prescribe medications for uses other than those for which the Food and Drug Administration has approved them, and there needs to be more scrutiny of the practice, researchers wrote in a report last week.

The report, published in the Nov. 24 issue of the journal Pharmacotherapy, found 14 medications that doctors prescribe for off-label use. The researchers called for more studies of the drugs to ensure their safety and efficacy when used to treat diseases for which they have not been approved.

 One example was AstraZeneca?s schizophrenia drug Seroquel (quetiapine), for which 76 percent of prescriptions were for diseases other than schizophrenia. Other drugs included antidepressants that doctors frequently prescribed for treating bipolar disorder. 

Off-label prescribing by doctors is legal, but off-label marketing by drug makers is not. An investigation by the Government Accountability Office in July found that the FDA did not have sufficient full-time staff to monitor off-label marketing.

X
This ad will auto-close in 10 seconds