FDA investigating gabapentinoids as possible addiction threat

pills opioid 375x121 FDA investigating gabapentinoids as possible addiction threatThe Food and Drug Administration (FDA) is investigating whether a type of painkiller called gabapentinoids are an addiction threat, FDA Commissioner Scott Gottlieb, M.D. said during a public workshop on Strategies for Promoting the Safe Use and Appropriate Prescribing of Prescription Opioids.

Gabapentinoids are FDA-approved drugs that are not opioids but have been approved to treat a variety of conditions including postherpetic neuralgia, fibromyalgia, partial onset seizures, and neuropathic pain associated with diabetes or spinal cord injuries. Brand-name gabapentinoids include Lyrica (pregabalin) and Neurotin.

“Some literature suggests that clinicians may be prescribing these drugs off-label to patients with various types of pain, as alternatives to opioids, outside the approved indications for gabapentinoids,” Gottlieb said.

The problem does not appear to be widespread as yet, but data suggest that misuse and abuse may be growing, both when taken alone and when taken with opioids, benzodiazepines, or other central nervous system depressants.

The FDA’s interest in gabapentinoids stems from the agency’s stepped-up efforts to tackle the nation’s opioid epidemic.

“The opioid crisis is taking many new, and unpredictable turns. And our experience demonstrates that we need to be vigilant and aggressive at the outset, as these new threats emerge. Our experience has shown that if new problems fester, they can quickly spiral out of control. And there are some new concerns we have … the possible risk of misuse and abuse of gabapentinoids,” Gottlieb said.

Misuse and abuse of these drugs can result in serious adverse events including respiratory depression and death.

In an effort to stay ahead of the potential problem with gabapentinoids, the FDA “tasked our surveillance epidemiology group at FDA … with investigating use of gabapentinoids,” the Gottlieb said. “We know we need to investigate and respond to signals of abuse as soon as signals emerge; we need to get ahead of these problems.”

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