FDA Warns of Respiratory Issues with Gabapentin in at-risk Populations

The FDA issued a warning for the pain drugs gabapentin and pregabalin concerning serious breathing difficulties that may occur in patients with respiratory risk factors. These potential risk factors include the use of opioid pain medicines and other drugs that depress the central nervous system (CNS), and conditions such as chronic obstructive pulmonary disease that reduce lung function. Elderly patients also are at higher risk.Gabapentin (Neurontin, Pfizer, among other brands) and pregabalin (Lyrica and Lyrica CR, Pfizer) are FDA approved for a variety of conditions, including seizures, nerve pain and restless legs syndrome.

“Our evaluation shows that the use of these medicines, often referred to as gabapentinoids, has been growing for prescribed medical use, as well as misuse and abuse,” the FDA stated in a press release. “Gabapentinoids are often being combined with CNS depressants, which increases the risk of respiratory depression. CNS depressants include opioids, anti-anxiety medicines, antidepressants and antihistamines. There is less evidence supporting the risk of serious breathing difficulties in healthy individuals taking gabapentinoids alone.“

The FDA is requiring new warnings about the risk for respiratory depression to be added to the prescribing information of the gabapentinoids, as well as mandating that drug manufacturers conduct clinical trials to further evaluate their abuse potential, particularly in combination with opioids. Special attention will be given to the respiratory depressant effects during this abuse potential evaluation.

The FDA reviewed several sources of data, including case reports submitted to the agency or published in the medical literature, observational studies, clinical trials and animal studies.

Among 49 case reports submitted to the FDA from 2012 to 2017, 12 people died from respiratory depression with gabapentinoids, all of whom had at least one risk factor.

To help the FDA track safety issues with medicines, clinicians are asked to report adverse events involving gabapentin, pregabalin or other medicines to the FDA MedWatch program at https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program

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