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What Clinicians Need to Know About New FDA Respiratory Warnings on Gabapentin and Pregabalin Products New warnings link this drug class to respiratory depression and abuse potential. The FDA has issued a drug safety warning for gabapentin and pregabalin, including Gralise and Lyrica, after a review of data suggested that use of the drugs may result in serious breathing difficulties in patients who have respiratory risk factors. FDA warns about serious breathing problems with seizure and nerve pain medicines gabapentin (Neurontin, Gralise, Horizant) and pregabalin (Lyrica, Lyrica CR) FDA Drug Safety Podcast That is why a new drug-safety communication from the FDA is so concerning. The agency is warning that serious breathing difficulties may occur in patients using gabapentin (Neurontin, Gralise, Horizant) or pregabalin (Lyrica, Lyrica CR) who have respiratory risk factors. The FDA is warning of serious, life-threatening respiratory problems associated with gabapentin. Respiratory concerns with gabapentin and pregabalin Respiratory depression, a highly mortal condition, due to gabapentin and pregabalin has been emerging for the past few years even in patients who were not on opioids, though post-marketing studies showed similar effects among patients taking these medications concurrently along with other Learn more about how anticonvulsant drugs gabapentin and pregabalin can cause respiratory depression and what to do if you take these for chronic pain. Abstract Introduction The combination of opioids and central nervous system depressants such as benzodiazepines and barbiturates has an additive effect on the frequency of oversedation and respiratory depression requiring naloxone use in hospitalized patients. Gabapentinoids (gabapentin and pregabalin) are frequently prescribed with opioids for their opioid-sparing and adjuvant analgesic Abstract Introduction: Respiratory depression and opioid-related death are reported when opioids are associated with gabapentinoids. Meta-analyses of randomized clinical trials investigating efficacy and safety of such association failed to assess these risks because of the lack of data. The aim of this systematic review was to investigate the risk of respiratory depression or death during WASHINGTON -- The FDA issued a warning that serious breathing difficulties may occur in patients taking gabapentin (Neurontin, Gralise, Horizant) or pregabalin (Lyrica, Lyrica CR) who have The potential for respiratory depression is highest when gabapentin or pregabalin is used in patients with risk factors such as increasing age (≥ 65 years of 2019). Gabapentinoids alone can cause respiratory depression, and coadministration with an opioid can increase the risk of opioid-related death. By Pat Anson, PNN Editor The U.S. Food and Drug Administration is warning that serious breathing problems can occur in patients who use gabapentin or pregabalin with opioids or other drugs that depress the central nervous system. The elderly and patients with lung problems are at higher risk when t In 2019 the FDA issued a warning about the potential risks of respiratory depression in patients taking gabapentin or pregabalin in combination with central nervous system (CNS) depressants such as opioids, antidepressants, and benzodiazepines. The review linked gabapentin or pregabalin to 49 cases of respiratory depression from 2012 to 2017. In 92% of those cases, the person had a respiratory risk factor, and 12 of the 49 people died. Respiratory risk factors were present in 92% of cases. FDA is mandating a warning of respiratory depression be added to the package inserts for gabapentin and pregabalin. Manufacturers of gabapentin and pregabalin are required to conduct clinical trials evaluating the proper use of these medications in combination with opioids. Gabapentin has been associated with a rare risk of severe respiratory depression even without concomitant opioid medicines. Patients with compromised respiratory function, respiratory or In a recent Drug Safety Update, the Medicines and Healthcare products Regulatory Agency (MHRA) warned about a rare risk of severe respiratory depression with gabapentin, with or without concomitant use of opioids.1 In England, 6.5 million prescriptions for gabapentin were dispensed in 2016.2 A European review of gabapentin was triggered by reports of patients developing respiratory depression The FDA has required new warnings in the labels of gabapentin (Neurontin, and others) and pregabalin (Lyrica, Lyrica CR, and generics) about the risk of life-threatening or fatal respiratory depression in patients with respiratory risk factors. 1 Respiratory risk factors include chronic obstructive pulmonary disease (COPD) and concurrent use of opioids or other CNS depressants. Elderly A Mayo Clinic research group published a case-control study describing the relationship between preoperative gabapentin exposure and the risk of postoperative respiratory depression in more than FDA is requiring new warnings about risk of respiratory depression in patients who use gabapentanoids with opioids or drugs that depress the nervous system
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