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Gabapentin FDA approval

Gabapentin was originally approved by the U.S. Food and Drug Administration (FDA) in December 1993, for use as an adjuvant (effective when added to other antiseizure drugs) medication to control partial seizuresin adults; that indication was extended to children in 2000. In 2004, its use for treating postherpetic neuralgia (neuropathic pain following shingles) was approved.

Gabapentin Approved and Off-Label Uses

Gabapentin is only approved by the Food and Drug Administration (FDA) as anticonvulsant drug for people with epilepsy and for nerve pain associated with shingles.

Because the drug is thought to be relatively safe, though, physicians prescribe gabapentin for a number of off-label uses. These can include the following:

  • Withdrawal from other substances, such as alcohol, cocaine and methamphetamine
  • Anxiety, mood disorders and attention deficit disorder
  • Sleep disorders
  • Migraines and back pain

Critics of off-label prescriptions of gabapentin point to the opioid epidemic as a stark lesson in what happens when doctors over circulate a reportedly safe drug.

“It got prescribed so much that everybody taking an opioid for chronic pain was also taking gabapentin,” Dr. James Patrick Murphy, a pain specialist based in Louisville, told NBC News. “People have a tendency to want to abuse anything that is mind-altering and a lot of times it is what is readily available to them.”

Dr. Murphy lamented that another consequence to over-prescribing and abuse associated with gabapentin will lead to policies that make it more difficult for patients who do well on the medication to get a prescription for it.

Responsible physicians will only prescribe dosages from 1,800 to 2,400 milligrams maximum per day of gabapentin for patients who need it, according to the Mayo Clinic.

The drug is also fairly inexpensive, even when it reaches street level sales. In Athens, Ohio, authorities report 300-milligram gabapentin pills go for 75 cents each.

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