Safety warning on the use of acetylcysteine

A safety warning was issued yesterday by the Commission on Human Medicines (CHM) on the use of acetylcysteine for the treatment of acute paracatemol overdose.

The commission has made the following recommendations. The licensed indication for acetylcysteine is now:

  • Paracetamol overdose irrespective of the plasma paracetamol level in circumstances where the overdose is staggered or there is doubt over the time of paracetamol ingestion; or
  • Paracetamol overdose with a timed plasma paracetamol concentration on or above a single treatment line joining points of 100 mg/L at 4 hours and 15 mg/L at 15 hours monogram, regardless of risk factors of hepatotoxicity.
  • An increase in the duration of administration of the first dose of intravenous acetylcysteine from 15 minutes to one hour.
  • Removal of hypersensitivity as a contraindication to treatment with acetylcysteine.
  • The provision of weight-based acetylcysteine dosing tables for adults and children.
  • Provision of a Technical Information Leaflet (TIL) for healthcare professionals in every pack of acetylcysteine, which gives more detailed instructions on the preparation of acetylcysteine infusions for administration.

More information is available on Medicines and Healthcare Regulatory Agency website including a number of useful resources.