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October 4 2017 The medicines regulator, the MHRA, has issued Drug Safety Updates on two...

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  • MHRA issues Drug Safety Updates for loperamide and miconazole

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Don Lavoie is alcohol programme manager at Public Health England and Gul Root is lead pharmacist, Health and Wellbeing Directorate, Public Health England
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a pharmacist consulting with patientOctober 4 2017

The medicines regulator, the MHRA, has issued Drug Safety Updates on two over-the-counter medicines.

 In the first, it has advised that patients taking warfarin should not use over-the-counter miconazole oral gel (Daktarin) available from pharmacies. This follows reports of bleeding events, including some with a fatal outcome in warfarin patients using miconazole oral gel.

If miconazole oral gel is needed for a patient taking an oral anticoagulant, the patient should be closely monitored and the anticoagulant effect carefully titrated, said the MHRA. In addition, health professionals should “advise patients taking prescription-only miconazole oral gel and warfarin that if they experience signs of over-anticoagulation, such as sudden unexplained bruising, nosebleeds, or blood in urine, they should stop using miconazole and seek immediate medical attention.”

The second DSU relates to high doses of loperamide associated with misuse or abuse, and reports of serious adverse cardiac reactions. Reports have been received of high dose loperamide being associated with events such as QT prolongation, torsades de pointes, and cardiac arrest, including some fatalities.

Health professionals are being reminded that naloxone may be used to treat symptoms of loperamide overdose. However, as loperamide’s duration of action is longer than that of naloxone, repeated treatment with naloxone may be necessary, and the patient should be monitored closely for 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,” says the Update.

Links:
MHRA Drug Safety Update – miconazole
MHRA Drug Safety Update – loperamide

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