Other safety alerts
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| United Kingdom: Loperamide (Imodium): reports of serious cardiac adverse reactions with high doses of loperamide associated with abuse or misuse |
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The Medicines and Healthcare products Regulatory Agency (MHRA) announces that there have been reports of cardiac events including QT prolongation, torsades de pointes, and cardiac arrest in patients who have taken high or very high doses of loperamide as a drug of abuse or for self-treatment of opioid withdrawal.
A European review of worldwide spontaneous reports identified 19 cases suggestive of cardiac rhythm disorders associated with loperamide abuse and misuse. In all cases, there was evidence of intentional high doses being taken for unapproved indications. In 13 of the 19 reports, QT prolongation or torsades de pointes were recorded with daily dosages ranging from 40–80mg up to 800mg (the recommended maximum daily dose is 16mg). Of the other 6 reports, one described syncope and irregular heart beat (daily dose 400–600mg), one described cardiac arrest with a rhythm of pulseless electrical activity (daily dose 400–800mg), one described ventricular dysrhythmia (daily dose 400mg), and one described asystole and death (chronic massive overdose). Two reports did not provide specific information on cardiac rhythm disorders or dose, with one describing syncope and death and one loss of consciousness.
As a result of the European review, all manufacturers of loperamide products have been asked to update their product information to include warnings of cardiac events associated with high doses. The patient leaflet will also be updated to warn patients never to take more than the recommended amount.
Advice for healthcare professionals:
- serious cardiovascular events (such as QT prolongation, torsades de pointes, and cardiac arrest), including fatalities, have been reported in association with large overdoses of loperamide
- healthcare professionals are reminded that if symptoms of overdose occur, naloxone can be given as an antidote
- since the duration of action of loperamide is longer than that of naloxone (1–3 hours), repeated treatment with naloxone might be indicated; patients should be monitored closely for at least 48 hours to detect possible CNS depression
- as for all medicines, pharmacists should remind patients not to take more than the recommended dose on the label
- report all suspected adverse reactions, including those associated with abuse or misuse, to the Yellow Card Scheme
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/loperamide-imodium-reports-of-serious-cardiac-adverse-reactions-with-high-doses-of-loperamide-associated-with-abuse-or-misuse
In Hong Kong, there are 63 registered pharmaceutical products containing loperamide. So far, the Department of Health (DH) has not received any case of adverse drug reaction related to loperamide. Related news was previously issued by the US Food and Drug Administration, and was posted on the Drug Office website on 8 Jun 2016. Letters to inform local healthcare professionals were issued by the Department of Health (DH) on the same day. Cardiotoxicity of loperamide related to the use of higher than recommended doses, and to its abuse or for self-treatment of opioid withdrawal is documented in reputable drug references such as Martindale: The Complete Drug Reference. DH will remain vigilant on safety update of loperamide issued by other overseas drug regulatory authorities.
Ends/Wednesday, Sep 27, 2017
Issued at HKT 16:00
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