Summary Safety Review - Gabapentin - Assessing the Potential Risk of Serious Breathing Problems

Summary Safety Review - Gabapentin - Assessing the Potential Risk of Serious Breathing Problems In 2014, the product information for gabapentin products was updated to warn about the risk of serious breathing problems (respiratory depression) when it is used with an opioid. While reviewing safety information given by the manufacturer for this change, Health Canada found cases of respiratory depression in patients treated with gabapentin alone. Therefore, this current safety review was carried out to assess the possibility of the same concerns in patients using gabapentin alone (when not taken with opioids) and to find out if more safety measures were needed. 2024-05-09 Health Canada open-ouvert@tbs-sct.gc.ca Health and SafetySummary Safety ReviewGabapentinassessingpotential riskSerious Breathing Problemsrespiratory depressionused with an-opioid Summary Safety Review - Gabapentin - Assessing the Potential Risk of Serious Breathing ProblemsHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/safety-reviews/summary-safety-review-gabapentin-assessing-potential-risk-serious-breathing.html Summary Safety Review - Gabapentin - Assessing the Potential Risk of Serious Breathing ProblemsHTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medeffet-canada/examens-innocuite/resume-examen-innocuite-gabapentine-evaluation-risque-problemes-respiratoires.html

In 2014, the product information for gabapentin products was updated to warn about the risk of serious breathing problems (respiratory depression) when it is used with an opioid. While reviewing safety information given by the manufacturer for this change, Health Canada found cases of respiratory depression in patients treated with gabapentin alone. Therefore, this current safety review was carried out to assess the possibility of the same concerns in patients using gabapentin alone (when not taken with opioids) and to find out if more safety measures were needed.

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