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  • BTS issues new guideline on pleural mesothelioma

    BTS issues new guideline on pleural mesothelioma

    Tuesday, 20 February 2018 17:21
  • EMA says no new patients should be started on Esyma for uterine fibroids

    EMA says no new patients should be started on Esyma for uterine fibroids

    Tuesday, 13 February 2018 12:44
  • New warnings issued for pregnancy and women using valproate for epilepsy, migraine, or bipolar

    New warnings issued for pregnancy and women using valproate for epilepsy, migraine, or bipolar

    Tuesday, 13 February 2018 12:40
  • EMA updates recommendations on avoidance of retinoids in pregnancy and effect on mental health

    EMA updates recommendations on avoidance of retinoids in pregnancy and effect on mental health

    Monday, 12 February 2018 14:44
  • New Drug Safety Updates issued for mycophenolate mofetil and misoprostol

    New Drug Safety Updates issued for mycophenolate mofetil and misoprostol

    Friday, 09 February 2018 15:24

a pharmacist consulting with patientOctober 4 2017

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

 The first DSU relates to high doses of loperamide associated with misuse or abuse, and reports of serious adverse cardiac reactions. The MHRA has received reports 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.

In the second, the MHRA has advised that patients taking warfarin should not use over-the-counter miconazole oral gel (Daktarin). 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. 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.”

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

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