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Pediatricians Update Guidelines For Off-Label Drugs


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A leading pediatricians’ group is urging doctors to use evidence and their best judgement in prescribing “off-label” drugs, a practice that’s common among kids with autism and other developmental disabilities.

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.

The guidance — which is an update to a policy statement first issued in 2002 — has special significance for young children, those born preterm and kids with chronic or rare diseases, those behind the policy statement indicated.

“Our goal is to provide children with the best care possible, and scientific evidence remains the best way to make treatment decisions,” said Kathleen Neville of Children’s Mercy Hospital in Kansas City, Mo. who chairs the American Academy of Pediatrics’ Committee on Drugs and spearheaded the new recommendations.

“There’s still much work to be done. Ultimately, all drugs used to treat children should have sufficient age-appropriate evidence to support updated labeling,” Neville 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.

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Comments (2 Responses)

  1. Dr. Neil Ackerman says:

    Most of my patients are kids on Medicaid. The insurance companies backing med expenses for these kids will not cover any off label use, in almost all cases. Intuniv, for instance, may be helpful for Asperger patients who easily may become upset, or for autistic patients with significant anger issues, but you usually have to have ae med. diagnosis of ADHD to use th

  2. Dr. Neil Ackerman says:

    correction: have a diagnosis of ADHD to use the med.

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