OFF-LABEL PRESCRIPTIONS [ back to What's New ]
Because of the rigors of the approval process, the FDA invariably approves new prescription drugs for just one purpose (e.g. headache relief). Very frequently physicians will entertain a hunch that the drug may be effective in treating other conditions (e.g. depression) for which the RX drug has not been formally tested, studied and approved by the FDA, and this is called off-label prescribing. This kind of prescribing is legal, but amounts to experimentation. A recent decision by a Superior Court in Philadelphia, PA, entitled Southard v. Temple University Hospital held that orthopaedic surgeon who implanted bone screws in a spinal fusion procedure for which they had not yet received FDA approval, had a legal duty to inform their patients before they made their decision to have the surgery. The privilege of off-label prescribing allows physicians to use their creativity and intuition, and can be of major benefit to suffering patients. However, it is important that patients (or their decision makers if they are under conservatorship) have the information first that this type of prescribing lacks FDA approval and carries certain unknowns. This is fair and appropriate. Persons with TBI should check with their physician whether the prescription is for an approved or off-label use and what risks they may be incurring in trying the medicine for their condition. Prudent self-protection means being informed of all relevant considerations in taking a medication, and this is  one of them.