Some painkillers (paracetamol, over-the-counter non-steroid anti-inflammatory drugs (NSAIDs) and acetylsalicylic acid) are often used without medical advice for pain and high temperature. To improve proper use of these drugs, the FAMHP is drawing attention to a number of precautionary measures. The FAMHP also reminds holders of marketing authorisations that directives have recently been updated as regards medication containing paracetamol.
In France, the competent authority for medication (agence nationale de sécurité des médicaments, ANSM) has decided that from 15 January 2020 non-prescription medication containing paracetamol, aspirin (acetylsalicylic acid) and ibuprofen would no longer be freely available in pharmacies. The ANSM’s intention with this measure is to reinforce the advisory role of the pharmacist in the proper use of medication. In Belgium patients never have direct access to medication in pharmacies, but the FAMHP wishes to remind patients and healthcare professionals of a number of important points to improve correct use of pain and fever medication.
Paracetamol overdose risks
As a general rule, paracetamol is the first choice to relieve pain and high temperature thanks to its relatively favourable safety profile at normal doses. In the event of an overdose, paracetamol can cause serious liver damage, can require a liver transplant and can lead to death. It is therefore important to respect the dosage and the information notice in the summary of product characteristics (SPC) and public information notice.
- Use the lowest effective dose possible for the shortest possible period to reduce pain or high temperature. Comply with the maximum dose and the minimum interval of 4 hours between doses every 24 hours and the maximum length of treatment mentioned in the information notice.
- Check whether other medication taken by the patient contains paracetamol to avoid overdose due to the involuntary ingestion of paracetamol under different brand names.
- Where risk factors are present (e.g. adult body weight below 50 kg, liver failure, chronic alcohol intake, serious kidney failure, fasting, chronic malnutrition, etc.), hepatic toxicity can occur at lower doses of paracetamol (02.2018 — BCFI).
- Pregnant women can take paracetamol if clinically necessary and provided they comply with the conditions of use: lowest effective dose possible for the shortest possible period, repeated as little as possible.
NSAIDs and acetylsalicylic acid should be taken for the shortest possible period
It is important to respect the dosage and the information notice in the SPC and the notice for NSAIDs and acetylsalicylic acid.
- Use the lowest effective dose possible for the shortest possible period. Stop treatment as soon as symptoms disappear and observe the maximum treatment period mentioned in the information notice.
- Do not take two different anti-inflammatories simultaneously.
- Avoid using this medication if you have chickenpox or shingles because the risk of serious skin complications increases in these situations.
- Pregnant women should avoid taking this medication during pregnancy. NSAIDs and acetylsalicylic acid are contraindicated during the third trimester of pregnancy.
NSAIDs and acetylsalicylic acid can have serious adverse gastro-intestinal, renal or cardio-vascular effects (09.2014 – CPIB). The ANSM recently drew attention to the risk of serious infectious complications related to the use of ibuprofen and ketoprofen (10.2019 — CBIP). This risk is currently being analysed in more depth at European level, and the FAMHP will publish the results once the analysis is completed.
Medication containing paracetamol: Recently updated guidelines for marketing authorisation holders
The FAMHP reminds holders of marketing authorisations for medication containing paracetamol that guidelines have been drawn up for this medication. The aim of this document is to standardise the minimum safety information that must be included in the SCP and the public information notice. These guidelines have recently been modified in line with the PRAC recommendations (Pharmacovigilance Risk Assessment Committee) of the EMA (European Medicines Agency) for paracetamol.