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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 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 FDA issued a warning in December 2019 that serious breathing difficulties may occur in patients using gabapentin (Neurontin, Gralise, Horizant) or pregabalin (Lyrica, Lyrica CR) who have respiratory risk factors.¹ The risk factors include the use of opioid analgesics and other drugs that depress the central nervous system (CNS) and 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. Among those factors are use of opioid pain medicines and other drugs that depress the central nervous system (CNS), as well as conditions such as The SmPCs for gabapentin and pregabalin include respiratory problems under ‘undesirable effects’; however, as the authors say, there are no recommendations to apply this to practice. This applies in all countries, particularly post-industrial societies. On December 19, 2019 FDA is warning that serious breathing difficulties may occur in patients using gabapentin (brand names Neurontin, Gralise, Horizant) or pregabalin (brand names Lyrica, Currently, gabapentin and pregabalin are US Food and Drug Administration-approved for postherpetic neuralgia in adults as well as adjunctive therapy in the treatment of partial-onset seizures. 6, 7 Gabapentinoids (gabapentin and pregabalin) are prescribed frequently in the hospital as well as in the outpatient setting for off-label indications Starting gabapentinoids at a low dose and titrating carefully is recommended to reduce the risk of respiratory depression in patients with respiratory risk factors and in the elderly. Reductions in the dosage of gabapentin and pregabalin are necessary in patients with renal impairment. ISSUE: FDA 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 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 Gabapentin has been associated with a rare risk of severe respiratory depression even without concomitant opioid medicines. Gabapentin can lead to respiratory depression in people with reduced lung function due to COPD. That’s when your breathing is too slow and ineffective. When this is the case, FDA is warning that serious, life-threatening, and fatal respiratory depression has been reported with the gabapentinoids, gabapentin (Neurontin, Gralise, Horizant) and pregabalin (Lyrica, Although gabapentin is widely perceived as safe [5,6], drug-induced respiratory depression has been described when gabapentin is used alone or in combination with other medications [7–10]. Indeed, the product monograph was amended in 2014 to warn about possible respiratory depression when combined with opioids [ 11 ]. FDA is requiring new warnings about the risk of serious breathing difficulties that can lead to death in patients who use gabapentanoids with opioid pain medicines or other drugs that depress the 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 FDA also warned the medication could increase breathing difficulties in patients with underlying gabapentin (Neurontin, Gralise, Horizant) and pregabalin (Lyrica, Lyrica CR) • Respiratory problems can be life-threatening, so seek medical attention immediately A large primary care database review showed that in 2017, 21.8% of patients with a new prescription for gabapentin and 24.1% of patients with a new prescription for pregabalin received a concomitant prescription, primarily for opioids. 2 In response to increasing reports of respiratory depression, the Medicines and Healthcare Products Although these drugs, which include gabapentin (Neurontin) and pregabalin (Lyrica), are still believed to be far safer than opioids for long-term use, the U.S. Food and Drug Administration (FDA) is now warning that they may cause “respiratory depression.” Understanding Gabapentin-Induced Respiratory Depression How Gabapentin Affects Breathing. Gabapentin and its close relative, pregabalin, are known as gabapentinoids. While not opioids, these drugs can depress the central nervous system, which includes the area of the brain that controls breathing.
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