On Thursday, the U.S. Food and Drug Administration issued a drug safety communication and warned that patients using gabapentin (Neurontin) or pregabalin (Lyrica), along with opioids or other drugs acting on the central nervous system, are at risk of developing serious respiratory issues.
In a statement, Dr. Douglas Throckmorton, Deputy Director for Regulatory Programs at the FDA’s Center for Drug Evaluation and Research, said, “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,” he added.
Dr. Throckmorton continued, “We are also requiring the drug manufacturers to conduct clinical trials to further evaluate the abuse potential of gabapentinoids, particularly in combination with opioids, with special attention being given to assessing the respiratory depressant effects.”
Gabapentinoids include gabapentin, pregabalin, and their generic versions.
The FDA has approved gabapentin and pregabalin for a variety of conditions, such as nerve pain, seizures, and restless legs syndrome (RLS). The FDA noted that these drugs also are prescribed off-label along with other types of painkillers, including opioids.
According to reports submitted to the drug regulatory body, life-threatening breathing difficulties may occur when gabapentinoids are taken by patients with pre-existing lung issues.
The FDA received 49 such cases between 2012 and 2017, of which, 12 died from severe respiratory depression after using gabapentinoids.
Dr. Throckmorton said, “Our goal in issuing today’s new safety labeling change requirements is to ensure healthcare professionals and the public understand the risks associated with gabapentinoids when taken with central nervous system depressants like opioids or by patients with underlying respiratory impairment.” The FDA has urged clinicians to report side effects associated with gabapentinoids or any other drugs that act on the central nervous system.
