Neuropathic pain is among the most common types of pain. But many cases do not respond to the usual medication such as nonsteroidal anti-inflammatory drugs. Clinical experience sometimes show that a drug may be useful for conditions other than that approved. Such uses are called off-label use. They are often widespread and accepted from the medical practice. One of those drugs is Gabapentin. It was approved by the U.S. Food and Drug Administration (FDA) in 1993 with the sole indication as adjunctive therapy in the treatment of partial seizures, in patients over the age of the 12 years. In October 2000, it was approved as adjunctive therapy for partial seizures in patients age 3-12 years. In 2002, it was approved for the treatment of postherpetic neuralgia in adults.
Off-label uses of Gabapentin include bipolar disorder, neuropathic pain, diabetic neuropathy, attention deficit disorder, drug and alcohol withdrawal seizures, essential tremor, hot flashes, migraine prophylaxis, neuropathic pain syndromes, and restless leg syndrome.
For the treatment of bipolar disorder, various experts have concluded that Gabapentin should not be recommended for that use.Results from a cross-over study suggest other medication such as lamotrigine may be superior for the management of refractory mood disorders.
For the treatment of pain syndromes, peripheral neuropathy, and diabetic neuropathy. The exact mechanism of action of Gabapentine is unknown. However, an hypothesis suggest an action on the voltage-activated calcium ion channels at the postsynaptic dorsal horn, thus interrupting the series of events that leads to the sensation of neuropathic pain.
For the treatment of complex regional pain syndrome. The available information is insufficient to support the use of gabapentin in this condition. Other recognized medical treatments include adrenergic blockers, nonsteroidal anti-inflammatory drugs, calcium channel blockers, phenytoin, opioids, and calcitonin.
For the treatment of attention deficit disorder. There is no evidence to support the use of Gabapentin in ADHD.
For the treatment of restless leg syndrome. This syndrome is an awake phenomenon characterized by an intense, irresistible urge to move the legs, associated with sensory complaints, motor restlessness, worsening of symptoms at rest and relief with motor activation, and increased severity in the evening or during the night. No control trials assess the effectiveness and safety in the treatment of this condition. The following agents have sufficient evidence to treat this condition: levodopa with decarboxylase inhibitor and pergolide, oxycodone and propoxyphene, or carbamazepine.
For the treatment of migraine. Gabapentine is only cost effective for migraine prophylaxis in patients who experience very frequent migraine headaches.
However, the off-label use of gabapentin for indications not approved by the FDA should be only for cases where solid research support the uses (e.g. diabetic neuropathy and prophylaxis of frequent migraine headaches).
off-label use must involve a risk-benefit analysis and should take into account the amount of evidence available for the off-label use.
Disclaimer: This article should be used for information purposes only. For any treatment of diseases a health care practitioner should always be consulted.
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