Revised: 26 June 2013

Safety Information

Paracetamol Associated with Asthma Symptoms

September 2008

Fax sent to healthcare professionals

The Lancet (20 September) has published results from a study: Association between paracetamol use in infancy and childhood, and risk of asthma, rhinoconjunctivitis, and eczema in children aged 6 – 7 years: analysis from Phase Three of the ISAAC programme (Prof R Beasley et al).

In response to this study, the New Zealand media have reported that paracetamol may cause asthma. This information presented to the public may cause concern for parents and carers.

The article is based on retrospective questionnaires relating to whether parents of 6 -7 year old children used paracetamol for the treatment of fever within the last 12 months and during the first year of their child's life.

The following findings are reported:

• Paracetamol, given in the first year of life, is associated with an increased risk of asthma symptoms developing by the age of 6 - 7 years (Odds Ratio 1.46 [95% CI 1.36 – 1.56]).
• Paracetamol, given in the first year of life, is associated with an increased risk of a child developing rhinoconjunctivitis or eczema by the age of 6 – 7 years (Odds Ratio 1.48 [95% CI 1.38 – 1.60] and Odds Ratio 1.35 [95% CI 1.26 – 1.45] respectively)
• Use of paracetamol within the last twelve months is associated with an increased risk of having current asthma symptoms.
• Use of paracetamol more than once a month within the last twelve months is associated with a three-fold increased incidence of asthma symptoms (Odds Ratio 3.01 [95% CI 2.70 – 3.36]).

The study was not designed to prove a causal association and has not done so.

The Medicines Adverse Reactions Committee (MARC) has reviewed the study and makes the following preliminary recommendations:

• Paracetamol is effective for the symptomatic treatment of fever and mild to moderate pain.
• Paracetamol has a generally benign side effect profile when used appropriately.
• As with any medication, paracetamol should be used only as indicated.
• Alternatives to paracetamol include ibuprofen and diclofenac. Prescribers should however, consider the risks associated with these alternatives such as causing renal damage in dehydrated children as well as gastro-intestinal irritation, ulceration and bleeding.
• Aspirin should not be used in children under 12 years of age.

Susan Martindale
Acting Group Manager
Medsafe