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Combining gabapentinoids with opioids or other drugs known to depress the central nervous system increases the risk of respiratory distress or death. Patients at risk for this reaction include individuals who have an underlying respiratory impairment, such as patients with chronic obstructive pulmonary disease and the elderly. Medications affected by this warning include gabapentin (brand Gabapentin has been associated with a rare risk of severe respiratory depression even without concomitant opioid medicines. Patients with compromised respiratory function, respiratory or The three observational studies from one academic medical center found a relationship between gabapentinoids given before surgery and respiratory depression occurring after different types of surgery. 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. In multimodal pain management, gabapentin mediated additive and/or synergistic effects with opioids enable reduced opioid doses but increase the risk of respiratory depression and overdose. These dose-dependent interactions amplify sedative effects, particularly in vulnerable populations such as the elderly. 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. 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. 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 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 "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 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 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. 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. This same research group conducted another case-control study describing the relationship between preoperative gabapentin exposure and the risk of postoperative respiratory depression in more than Learn more about how anticonvulsant drugs gabapentin and pregabalin can cause respiratory depression and what to do if you take these for chronic pain. 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 FDA is requiring new warnings about risk of respiratory depression in patients who use gabapentanoids with opioids or drugs that depress the nervous system “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. 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. 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
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