Public Citizen Calls For Gabapentin To Be Classified As a Controlled Substance

Gabapentin-based drugs are increasingly abused for recreational use, adding to the ongoing opioid epidemic, Public Citizen warns.

The prominent consumer safety organization Public Citizen has filed an FDA petition, calling for the epilepsy drug gabapentin to be classified as a schedule V controlled substance, warning that users using the prescription medication to get high, which may lead to addiction, overdose and some deaths.

Gabapentin is approved by the U.S, Food and Drug Administration (FDA) to treat epilepsy and neuropathic pain. It is also widely prescribed off label for treatment of alcohol use disorder, chronic cough, hiccups, post-surgical pain, and post-menopausal hot flashes. The closely related drug gabapentin enacarbil is approved to treat restless leg syndrome and post-therapeutic neuralgia. The drugs are also sold under brand names Neurontin, Gralise and Horizant, or for pregabalin-based drugs Lyrica and Lyrica CR, as well as multiple generic versions.

According to the Public Citizen petition, both gabapentin and gabapentin enacarbil should be classified as controlled substances due to the serious risk of misuse and abuse.

From 2011 to 2017, total prescriptions for gabapentin doubled to 64.8 million per year, and data indicates roughly 80% of prescriptions involve off-label uses that were never approved as safe and effective by drug regulators. Side effects of gabapentin can include dizziness, sleepiness, euphoria, psychedelic effects, dependence, and respiratory depression when used with central nervous system depressants, like opioids or benzodiazepines.

In 2019, federal health officials warned using opioids with gabapentin drugs, like Neurontin, or other drugs used to treat nerve conditions, can lead to dangerous breathing problems that can result in hospitalization and death.

There were more than 72,000 reports to the American Association of Poison Control Centers in 2016 involving gabapentin. This was up from roughly 5,900 four years earlier. One report indicated 15% of adults in Kentucky report using the drug to “get high,” and one study indicated taking Neurontin increased a person’s risk of suicidal behaviors, unintentional overdose and other violent behavior.

“Surveillance and control activities that can reduce the dangers of abuse and misuse are urgently needed,” wrote Public Citizen in the petition.

Gabapentin is structurally similar to the naturally occurring neurotransmitter gamma-aminobutyric acid (GABA) and the drug pregabalin, which has been classified as a schedule V controlled substance since 2005.

As of November 2020, seven states have classified gabapentin as a schedule V drug and 12 states require prescription monitoring. The United Kingdom classified both gabapentin and pregabalin as controlled substances since 2019.

“The National Forensic Laboratory Information System and the Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) system have both observed hundreds to thousands of surveillance reports between 2002 and 2017 indicating that gabapentin is increasingly being diverted illegally across the U.S,” the Public Citizen petition notes.

Furthermore, evidence indicates more and more users are misusing, abusing or becoming addicted to the drug.

“The failure of the DEA and FDA to schedule gabapentin is even more troubling given that the drug has been identified as a contributing factor to the opioid overdose epidemic that continues to plague our nation,” said Michael Abrams, senior health researcher with Public Citizen’s Health Research Group and lead author of the petition.