WASHINGTON -- The FDA that serious breathing difficulties may occur in patients taking gabapentin (Neurontin, Gralise, Horizant) or pregabalin (Lyrica, Lyrica CR) who have respiratory risk factors.
These risk factors include taking opioids or other drugs that depress the central nervous system (CNS), and conditions such as chronic obstructive pulmonary disease (COPD) that reduce lung function, the agency said. Elderly patients also are at higher risk.
"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," Douglas Throckmorton, MD, deputy director for Regulatory Programs in the FDA's Center for Drug Evaluation and Research, said in a statement.
The agency also is requiring updates to gabapentinoid labels to include new warnings of potential respiratory depressant effects, and "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," Throckmorton added.
Gabapentin and pregabalin have from 2002 to 2015. The drugs have been approved for a variety of conditions including seizures, nerve pain, and restless legs syndrome, and both frequently are used for .
Prescription use of gabapentinoids increased from 2012 to 2016, the agency reported. The estimated number of patients filling a gabapentin prescription annually climbed from 8.3 million to 13.1 million in that period, while the number filling a pregabalin prescription rose from 1.9 million to 2.1 million.
A substantial percentage of patient encounters in 2016 -- 14% for gabapentin, 19% for pregabalin -- also involved opioids, the FDA said. The agency has kept a watch on whether abuse or misuse of gabapentinoids is increasing.
Prescribers should start gabapentinoids at the lowest dose and monitor patients for symptoms of respiratory depression and sedation if co-prescribing gabapentinoids with an opioid or other CNS depressant such as a benzodiazepine, the agency noted.
"Our goal in issuing today's new safety labeling change requirements is to ensure health care professionals and the public understand the risks associated with gabapentinoids when taken with CNS depressants like opioids or by patients with underlying respiratory impairment," Throckmorton said.
"However, we do not want to unintentionally increase opioid use by turning prescribers away from this class of pain medications," he added.