Researchers have assembled a list of 14 widely prescribed drugs they believe urgently need additional study to determine safety and effectiveness for off-label use. Their list, which specifically targets meds that are widely used off-label without proper scientific backing, include a number of popular antidepressants and antipsychotics. And the most common off-label use for six of the drugs was for bipolar disorder.
“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,” Randall Stafford, associate professor of medicine at the Stanford Prevention Research Center, who is the senior author of the study, says in a statement. “This list of priority drugs might be a start for confronting the problem of off-label use with limited evidence.”
At the top of the list was AstraZeneca’s Seroquel antipsychotic, which was approved by the FDA to treat schizophrenia. Not only did this drug lead all others in its high rate of off-label uses with limited evidence (76 percent of all uses of the drug), the researchers say it raised additional concerns because of its high cost at $207 per prescription, heavy marketing and the presence of a “black-box” warning from the FDA.
The study, which appears in Pharmacotherapy, appears only days after an FDA advisory committee criticized the growing off-label use of antipsychotics in children and amid an investigation by a group of state Medicaid directors. The consortium is evaluating the use of the drugs in children on state Medicaid rolls to ensure they are properly prescribed. The growing use of the medicines has been driven partly by the sudden popularity of the diagnosis of pediatric bipolar disorder.
