The prescription epilepsy drug gabapentin is under fire from the consumer safety group Public Citizen, claiming in a Food and Drug Administration (FDA) petition that some users get high on it, leading to overdoses, addiction, and sometimes death. The consumer watchdogs want the FDA to classify gabapentin as a Schedule V controlled substance.
Although gabapentin is approved to treat epilepsy and neuropathic pain, physicians have widely prescribed it off-label for numerous other conditions, such as hot flashes post-menopause, alcohol abuse, pain after surgery, and chronic cough. Public Citizen also wants the related drug, gabapentin enacarbil, prescribed for neuralgia and restless leg syndrome, classified as a Schedule V. The brand names at issue are Lyrica, Lyrica CR, Gralise, Horizant, and Neurontin.
Public Citizen argues that 80 percent of gabapentin prescriptions between 2011 and 2017 were off-label and were never approved as safe or effective for alternate uses. The American Association of Poison Control Centers in 2016 reported 72,000 issues with gabapentin, an increase of 5,900 from the previous year. Fifteen percent of Kentucky residents reported using gabapentin to get high and one study linked Neurontin users with an increased risk of overdose, violence, and suicidal behavior.
Additionally, side effects reported include dizziness, euphoria, psychedelic episodes, dependence, and slower respiratory response in combination with depressants like benzodiazepines or opioids. Federal health officials in 2019 linked using opioids with Neurontin or similar drugs with catastrophic breathing problems that can, at worst, result in death.
In the petition it filed with the FDA, Public Citizen advocated for better control and even surveillance to reduce the dangers of gabapentin abuse. In its advocacy for classifying gabapentin as a controlled substance, it notes that the drug is linked to the neurotransmitter gamma-aminobutyric acid (GABA) and pregabalin, which has been a classified Schedule V controlled substance since 2005. By the end of 2020, seven states agreed and classified gabapentin as a Schedule V drug; and worldwide, the United Kingdom in 2019 classified both as controlled substances. Additionally, twelve U.S. states monitor gabapentin prescriptions.
Schedule V drugs are deemed as having a low potential for abuse compared to Schedule IV and higher drugs, but users are still at risk for physical or psychological dependence. Schedule V drugs are recognized as having accepted medical use in treatment in the United States.
Public Citizen also argues that gabapentin continues to be distributed illegally across the U.S., citing data from the National Forensic Laboratory Information System and the Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) system. The group alleges that thousands of surveillance reports between 2002 and 2017 confirm the gabapentin diversion to illegal purposes and that the problem is growing.
Michael Abrams, spokesperson, senior researcher for Public Citizen, and lead author of the FDA petition said, “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.”