WASHINGTON — The FDA is looking at whether gabapentinoids are an addiction threat, FDA Commissioner Scott Gottlieb, MD, said Thursday.
Gabapentinoids such as pregabalin (Lyrica) as well as the original agent gabapentin (Neurontin) are approved to treat a variety of conditions, including post-herpetic neuralgia, fibromyalgia, and neuropathic pain associated with diabetes, and “some literature suggests that clinicians may be prescribing these drugs off-label … as alternatives to opioids, outside approved indications,” Gottlieb said at a meeting here on safe opioid prescribing, sponsored by the Duke Margolis Center for Health Policy.
“Our preliminary findings show that abuse of gabapentinoids doesn’t yet appear to be widespread, but use continues to increase, especially for gabapentin,” he said. “FDA is investigating whether abuse or misuse is also increasing and if so, what should be done to address this problem.”
Although the data are limited, they do suggest that gabapentinoid abuse and misuse “may be growing, both [when] taken alone and in combination with opioid, benzodiazepines, or other central nervous system depressants,” Gottlieb continued. “We’re concerned that abuse and misuse of these drugs may result in serious adverse events such as respiratory depression and death. We want to understand changes in how patients are using these medications.”
To that end, “we’ve looked at social media websites where opioid users share comments and describe methods and motivations for abusing or misusing gabapentinoids,” he said. “We’ve tasked our surveillance epidemiology group at FDA … with investigating use of gabapentinoids. We’ll have more to say about this challenge soon … We know we need to investigate and respond to signs of abuse as soon as signals emerge; we need to get ahead of these problems.”