MHRA Drug Safety Update January 2017

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The January MHRA Drug Safety Update is now available and contains information on the following:

Direct-acting antiviral interferon-free regimens to treat chronic hepatitis C: risk of hepatitis B reactivation  All patients should be screened for hepatitis B before starting treatment for chronic hepatitis C with direct-acting antiviral interferon-free regimens.

Direct-acting antivirals to treat chronic hepatitis C: risk of interaction with vitamin K antagonists and changes in INR  INR should be monitored closely during treatment of chronic hepatitis C with direct-acting antivirals in patients also receiving vitamin K antagonists (eg, warfarin), because of possible changes in liver function during treatment.

Apremilast (Otezla ▼): risk of suicidal thoughts and behaviour  There is an increased risk that some patients may experience psychiatric symptoms with apremilast, including depression and suicidal thoughts.

Intravenous N-acetylcysteine (NAC) for paracetamol overdose: reminder of authorised dose regimen; possible need for continued treatment with NAC  The authorised dose regimen for N-acetylcysteine (NAC) in paracetamol overdose is 3 consecutive bags given intravenously over 21 hours.

Letters sent to healthcare professionals in December 2016  A summary of letters sent to relevant healthcare professionals in December 2016: