Other safety alerts
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| The United Kingdom: Benzodiazepines and opioids: reminder of risk of potentially fatal respiratory depression |
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The Medicines and Healthcare products Regulatory Agency (MHRA) announces that it recently received a report from a Coroner following death by respiratory arrest of a man given the benzodiazepine clonazepam, and among other drugs, the opioid methadone.
The MHRA reminds healthcare professionals that benzodiazepines and benzodiazepine-like drugs and opioids can both cause respiratory depression. When co-prescribed, the depressive effect on the central nervous system is additive. Therefore, they should only be co-prescribed if there is no alternative. Warnings about the risks of co-prescribing these products were reviewed in Europe in 2018.
If co-prescribing of these drugs is considered necessary, the lowest effective doses should be used and for the shortest duration. All patients should be closely monitored. If methadone is prescribed, the respiratory depression effects could be delayed. Monitoring should continue for at least 2 weeks following initiation or changes to prescribing such as increased dose or the addition of a new medicine that may interact with opioids.
Advise patients to always read the leaflet for the medicines that they have been supplied. For benzodiazepines or related drugs and opioids, the patient information leaflet advises that these medicines increase the risk of drowsiness, difficulties in breathing (respiratory depression), and coma, and that these effects may be life-threatening. Therefore, patients should seek medical advice if these symptoms occur.
Patients are advised to inform their prescribers about any opioids or sedative medicines they are taking, and to follow any dose recommendation closely. The leaflet advises them that it may be helpful to inform friends or relatives of the signs and symptoms of respiratory depression and sedation and be aware of the need to seek medical attention if they occur.
Healthcare professionals are advised:
- Benzodiazepines (and benzodiazepine-like drugs) and opioid medicines (opioids) can both cause respiratory depression; when used together, additive effects on the central nervous system increase the risks of sedation, respiratory depression, coma, and death.
- Only prescribe benzodiazepines (or benzodiazepine-like drugs) and opioids together if there is no alternative.
- If a decision is made to co-prescribe, use the lowest doses possible for the shortest duration of time and carefully monitor patients for signs of respiratory depression.
- If there is any change in prescribing such as new interactions or dose adjustments, re-introduce close monitoring of the patient.
- If co-prescribing methadone with a benzodiazepine or benzodiazepine-like drug, closely monitor for respiratory depression for at least 2 weeks following initiation or changes to prescribing because the respiratory depression effect of methadone may be delayed.
- Advise patients of the symptoms of respiratory depression and sedation and the need to seek immediate medical attention if these occur.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/benzodiazepines-and-opioids-reminder-of-risk-of-potentially-fatal-respiratory-depression
In Hong Kong, there are registered pharmaceutical products which are opioids and benzodiazepines and related drugs. So far, the Department of Health (DH) has received one case of adverse drug reaction of acute respiratory distress syndrome related to an opioid. The DH has not received any case of adverse drug reaction of respiratory depression related to benzodiazepines and related drugs.
Related news on the risk of respiratory depression with the combined use of opioids and benzodiazepines was previously issued by the US Food and Drug Administration, and was posted on the Drug Office website on 1 Sep 2016 and 21 Sep 2017. Letters to inform local healthcare professionals were issued by DH on 1 Sep 2016. Reports of severe respiratory depression with the combined use of opioids and benzodiazepines are documented in reputable drug references such as Martindale: the Complete Drug Reference. The DH will remain vigilant on safety update of the drugs issued by other overseas drug regulatory authorities.
Ends/Thursday, Mar 19, 2020
Issued at HKT 17:30
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