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Off-Label Meds Can Lead to a Medical Malpractice Suit

Steven E. North, Esq. and Laurence M. Deutsch, Esq.


Off-label prescriptions involve the administration of medication to a patient for reasons or conditions that have not been approved by the FDA and the manufacturer. Empirical experiences and studies, however, have led some practitioners to believe that off-label use of certain medications can be effective in treating conditions for which they have not been approved.

A recent study cited by Medscape.com revealed that younger physicians in particular have been prescribing antipsychotic medications to children with attention-deficit/hyper activity disorder (ADHD), conduct disorder and psychosis among other conditions despite the fact that they have not been approved to treat such problems.

Such practice is rife with potential for a medical malpractice suit. The most prevalent side effect, according to a 2014 study, is significant weight gain which in and of itself can have serious implications for a child, but such drug use can also affect a child’s heart and metabolism, trigger hypertension, and produce abnormalities in lipids.

The article suggests that greater scrutiny should be placed on these physicians, primarily psychiatrists, by requiring specific prior authorization, closer monitoring, and computerized alerts and reminders.

Medscape.com, “Off-Label Antipsychotic Prescribing Common in Very Young Kids,” December 12, 2016