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:
- Levetiracetam (Keppra) 100 mg/mL:
- Ammonaps (sodium phenylbutyrate):