Choked Up? –
December 19, 2019 – 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 tripled in use 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 off-label indications. 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.