Off-Label Uses of Medications

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Off label uses of medication occur when one takes a particular medication in a way that has not been approved by the federal Food and Drug Administration (FDA). The FDA requires that all prescription drugs sold in the United States be proven both safe and effective for specific uses. These approved, or “on-label” uses, are the sole means by which one may administer the drug. This system was established to test the safety and efficacy of all drugs and to protect and inform consumers about these products and their proper uses.

The FDA prohibits pharmaceutical companies from promoting off label uses of medication. The only marketing legally permissible for prescription drugs is for their FDA approved uses. In this way, the FDA’s system prevents big drug companies from promoting off label uses of medication and potentially posing a threat to consumer health. Pharmaceutical companies are not allowed to publish findings about research conducted regarding the off label uses of medication, unless that medication has been approved by the FDA for that specific purpose.

Unfortunately, though federal law prohibits pharmaceutical companies from promoting off label uses of medication, doctors can, in fact, lawfully prescribe medication for an off label use. This option has an array of potential patient benefits. A doctor may prescribe off label uses of medication when they deem it medically reasonable or appropriate given a patient’s individual health condition. Physicians learn of off label uses of medication through medical research, professional medical journals, peer lectures and presentations, and the advice trusted colleagues. Prescribing off label uses of medication is an acceptable medical practice when done by an informed, competent, and experienced physician.

The prescription of a medication for off label uses may prove favorable to patients when they are able to benefit from a drug that is not FDA approved for their specific condition. Physicians can promote off label uses of medication on an individual patient basis when they believe that doing so will be beneficial to their patients. Some common off label uses of medication include: antidepressants used to treat insomnia and pain, anticonvulsants for pain, clonazepam for anxiety, corticosteroids for cancer pain, beta-blockers for migraines, and NSAIDs for non-arthritic pain management.

These off label uses of medication may be safe and effective for patients as prescribed by their physician; however, the government prohibits the promotion of off label uses of medication by pharmaceutical companies with very good reason: the federal law against promoting off label uses of medication prevents pharmaceutical companies from exploiting or distorting medical research for financial gain at the expense of consumer health. It provides a very necessary check on big pharmaceutical companies to prevent them from financing large campaigns that pose a threat to consumer health.

When pharmaceutical companies do promote off label uses of medication, they can be held liable and subject to lawsuits against them.

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Free Off-Label Uses of Medications Consultation

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