In a policy statement issued Monday, the American Academy of Pediatrics said that with less than half of drugs labeled for use in children, it’s “more than likely” that doctors will prescribe medications for uses that are not specifically approved. However, that does not mean that the practice of prescribing “off-label” is “incorrect,” the group said.
Under the recommendations, prescribers should take into account “sound scientific evidence, expert medical judgment or published literature whenever possible” in determining whether a drug will benefit an individual patient.
“Off-label use of a drug should be done in good faith, in the best interest of the patient and without fraudulent intent,” the policy statement said.
Physicians should fully-document any use of drugs off-label and should warn patients and their parents if such use is experimental, the group said.
Off-label prescribing is common for children with autism, with research indicating that nearly two-thirds of kids on the spectrum take psychotropic drugs even though only two medications — Risperdal and Abilify — are approved by the Food and Drug Administration to treat symptoms associated with the developmental disorder