Off Label

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In December 1993, the FDA granted approval of the use of gabapentin, then sold under the brand name Neurontin, for the treatment of partial seizures. Today, largely thanks to off-label uses of the drug, gabapentin has become the seventh most commonly prescribed medication in the United States. Off-label use of a drug is using it to treat a condition despite that use being unapproved by the FDA. While not specifically illegal, off-label use of medications may be unethical and, in some cases, dangerous. In May 2002, gabapentin was approved for use in treating the pain of post-herpetic neuralgia (pain from a shingles infection). By far the most common use of gabapentin is in treating foot pain from diabetic neuropathy. While the use of gabapentin to treat this condition has been mostly successful, the use of gabapentin for this condition is unapproved by the FDA. In other words, this is an off-label use of the drug.

Since 2004, multiple manufacturers have introduced gabapentin-related medications to treat a host of illnesses and conditions. For example, Lyrica (pregabilin) has received FDA approval for use in diabetic neuropathy, postherpetic neuralgia, partial seizures, fibromyalgia, and nerve pain from spinal cord injuries. The extensive use of gabapentin for a wide variety of conditions beyond those formally approved by the FDA is most likely due to off-label marketing. In 2004, Warner Lambert (a manufacturer of gabapentin) settled litigation for $430 million and admitted guilt in connection to charges that the company illegally promoted gabapentin for uses unapproved by the FDA (while off-label use of a product is not illegal, advertising or marketing off-label use is illegal). Off-label marketing included educational programs, unrestricted grants to medical education companies, physician speakers, industry-funded studies, and advertising in publications.

The history of gabapentin raises serious questions about how the U.S. healthcare system responds when there is widespread off-label use of a product. Ideally, the FDA should approve medications based on limited clinical data and then allow physicians to use their clinical skills to test and formally evaluate new indications for drug usage. In the case of gabapentin, multiple clinical studies were published evaluating gabapentin for off-label use. These studies then increased off-label use and eventually off-label advertising. Regulatory oversight and surveillance efforts were missing in action leading to an upward spiral that eventually came to legal action.

Today, 25 years after the initial FDA approval of gabapentin, there is still limited evidence that supports the widespread off-label uses of the drug. The history of gabapentin use illustrates how additional regulatory oversight and postmarketing surveillance might have led to a more coordinated evaluation of the drug and could have led to use of the drug based on clear-cut medical evidence thereby allowing patients and clinicians to enjoy improved clinical evidence-based care.

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