FDA To Add Warnings To Gabapentin And Pregabalin About Risk Of Breathing Problems When Combined With Opioids And Certain Other Drugs

The AP (12/19, Perrone) reports the FDA announced that gabapentin and pregabalin “can cause dangerous breathing problems when combined with opioids and certain other drugs.” The agency will “add new warnings to packaging for” the drugs, which “are among the most prescribed in the U.S.”

HealthDay (12/19) reports that “the new warnings” are “based on a review of data from numerous sources, including case reports, observational studies, human trials and animal studies.” While the two gabapentinoids are approved by the FDA for “epilepsy, postherpetic neuralgia (pain following shingles), neuropathic pain associated with diabetic neuropathy, fibromyalgia, generalized anxiety disorder and restless legs syndrome,” they are also commonly prescribed off-label for “insomnia, migraine, social phobia, panic disorder, mania, bipolar disorder and alcohol withdrawal.”

Medscape (12/19, Brooks, Subscription Publication) reports Dr. Douglas Throckmorton, an FDA official, 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.”

MedPage Today (12/19, George) also covers the story.

Related Links:

— “FDA warns of breathing risks with popular nerve drugs, “Matthew Perrone, AP, December 19, 2019

Posted in In The News.