Briefly Noted

Abstract

Last month, the federal Food and Drug Administration (FDA) warned that combining gabapentin or pregabalin with central nervous system (CNS) depressants such as opioids could result in serious breathing problems for patients with underlying respiratory problems, or in the elderly. New labeling will be required on gabapentin and pregabalin, the FDA said. There is less evidence supporting such a risk in otherwise healthy people, the FDA said in the Dec. 19, 2019, warning. Gabapentin, first approved in 1993, is not a controlled substance. It is approved to treat various conditions, including seizures, nerve pain, fibromyalgia and restless legs syndrome. Pregabalin, first approved in 2004, is Schedule V on the Controlled Substances Act, the lowest‐risk category of controlled substance. “With the evolution of the opioid crisis, getting ahead of new concerns or addressing those that are already evident requires examining signs of misuse and abuse as soon as any signal emerges,” said Douglas Throckmorton, M.D., deputy director for regulatory programs in the FDA's Center for Drug Evaluation and Research, in announcing the warning. “Reports of gabapentinoid abuse alone, and with opioids, have emerged and there are serious consequences of this co‐use, including respiratory depression and increased risk of opioid overdose death. In response to these concerns, we are requiring updates to labeling of gabapentinoids to include new warnings of potential respiratory depressant effects.” Drug manufacturers are also being required to conduct clinical trials to evaluate the abuse potential of all gabapentinoids, particularly when combined with opioids, said Throckmorton. The downside is that prescribers could inadvertently increase opioid use by not using these medications, Throckmorton acknowledged, saying “we do not want to unintentionally increase opioid use by turning prescribers away from this class of pain medications.” For more information, go to https://www.fda.gov/drugs/drug‐safety‐and‐availability/fda‐warns‐about‐serious‐breathing‐problems‐seizure‐and‐nerve‐pain‐medicines‐gabapentin‐neurontin.