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Informed Consent and Shared Decision-Making: A Requirement to Disclose to Patients Off-Label Prescriptions

Posted Nov 15 2008 4:23pm

A 9-year-old with cerebral palsy received an injection of the neurotoxin “Botox” to relieve muscle spasms. This off-label use was legal but not approved by the US Food and Drug Administration (FDA) for this indication. People with headaches have also received Botox injections as a legal, but unapproved, treatment—in this case the FDA is investigating whether the manufacturer actually promoted the drug for this indication. In fact, the drug has some significant dangers leading to hospitalizations and deaths.

A more familiar instance of off-label drug use would be the example of a 47-year-old male presenting to his doctor with lower back pain. The doctor, having previously suggested over-the-counter medications, prescribes a drug to ease the pain. The doctor tells the patient to take the drug three times a day, but provides no other information. In this case, a reasonable person might wish to be told: that the prescribed drug gabapentin was approved by the FDA only to treat seizures in epilepsy—not for back pain; and (2) that no reliable research supports using the drug for back pain.

These examples are not uncommon, yet current practice does not require or even suggest that doctors disclose any of these facts to their patients. This article argues that as an extension of the legal doctrine of informed consent and the ethical duty of shared decision-making (SDM), patients should be told when a drug is being prescribed “off-label;” that is, it has not been approved for the indication and is being used experimentally.


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