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Safety warnings

Diarrhoea treatment associated with serious heart problems

The Medicines and Healthcare products Regulatory Agency (MHRA) has warned of serious cardiac adverse reactions in patients misusing or abusing loperamide by taking high or very high doses of the drug.

Loperamide, which is sold under the brand name Imodium as well as in generic form, is a synthetic opioid indicated for treatment of acute diarrhoea. The MHRA said that a European review identified 19 cases worldwide suggestive of cardiac rhythm disorders associated with loperamide abuse or misuse: in self-treatment of opioid withdrawal, for example. 

As a consequence, the MHRA said pharmacists should remind patients not to take more than the recommended dose on the label, and should report all suspected adverse reactions, including those associated with abuse or misuse, to the Yellow Card Scheme.

The Pharmacovigilance Risk Assessment Committee, the European Medicines Agency’s committee responsible for assessing and monitoring the safety of human medicines, has asked all manufacturers of loperamide products to update their product information with warnings of cardiac events associated with high doses. Patient information leaflets will also be updated with warnings that patients must never take more than the recommended amount of the drug.

Full details of the alert are available on the MHRA website.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2017.20203659

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