Class 4 drug alert – Caution in Use – Rifadin (rifampicin) capsules 150mg

16 Oct 2019

A Class 4 drug alert has been issued by the Medicines & Healthcare products Regulatory Agency (MHRA) for Rifadin (rimfampicin) capsules 150mg

Ref: EL (19)A/25

16 October 2019

Rifadin (rifampicin) capsules 150mg

(Manufactured by Aventis Pharma Ltd t/a Sanofi)

PL 04425/5915R

A Class 4 drug alert has been issued by the Medicines & Healthcare products Regulatory Agency (MHRA) for a specific batch of Rifadin (rifampicin) capsules 150mg.

Batch Number Expiry Date Pack Size First Distributed
9G020A 12/2021 1 x 100 capsules 16 October 2019

Sanofi has stated that the Patient Information Leaflet (PIL) has not been changed within the required timeframe. The change involves the addition of:

  • A potential side effect “Acute Generalized Exanthematous Pustulosis (AGEP)”
    • A widespread red, scaly rash with bumps under the skin, blisters and a fever which  occurs on  initiation of treatment
  • A potential side effect “risk of severe bleeding”
  • Inclusion of drug-drug interactions with:
    • Hepatitis C drugs (such as indinavir, efavirenz, amprenavir, nelfinavir, atazanavir, lopinavir, neviparine, daclatasvir, simeprevir, sofosbuvir and telaprevir)

All patients should seek immediate medical attention if they notice any of the above symptoms.

Pharmacists and pharmacy teams should check the Marketing Authorisation holder and the batch number when dispensing the product. When dispensing any of the affected batches, the PIL within the packaging should be replaced with the correct, updated version available from the eMC website.

Further information can be found on the MHRA section on the GOV.UK website.

Produced by the NPA Pharmacy Services team October 2019.