What are the risks of prescribing a medication for off-label use?
Because a particular use of the drug may be beneficial but uncommon, many drug manufacturers choose not to seek FDA approval for an off-label use due to cost and time factors. Congress has not prohibited the prescription of medications for non-FDA-approved (off-label) use. However, prescribing a medication for off-label use is not without risk, particularly in pediatrics. Physicians are still responsible for practicing prudent medicine. The available literature and the practices of similarly situated physicians would be evidence of compliance to the standard of care. In addition, physicians are encouraged to obtain a signed, written consent indicating the rationale for the medication, its risks, benefits, and alternatives. Information is available at the FDA web site.
Related Questions
- Do I need Informed Consent from a patient and/or their family, if I am providing off-label use of a medication? If so, what sort of information should be discussed during the informed consent process?
- What if I am currently taking a brand name maintenance medication that has a generic available and would be covered by the Generic Prescribing Program?
- Is there a psychiatrist available for prescribing medication, like for ADD or depression?
