Paracetamol use during pregnancy

A new Danish study [1] suggests a possible connection between mothers' use of paracetamol painkillers during pregnancy and the risk of developing disorders like ADHD (attention deficit hyperactivity disorder) in children.

The Danish Health and Medicines Authority's recommendations remain unchanged

The Danish Health and Medicines Authority does not find that the research data call for an immediate change of the recommendations for use of painkillers during pregnancy.

• The general recommendation is to take as little medicine as possible during pregnancy.
• To the extent possible, non-medical treatment should be used to ease mild and/or short-term pain during pregnancy.
• Paracetamol painkillers are still the common first-line treatment in pregnant women with pain or fever.
• If a pregnant woman needs pain relief for more than a couple of days, continued medical treatment should only take place in consultation with a doctor.
• Due to the risk of deformities, painkillers of the NSAID type (e.g. ibuprofen and diclofenac) should be used cautiously in the 1st and 2nd trimesters of pregnancy and must not be used in the 3rd trimester of pregnancy due to the risk of haemorrhage and circulatory disturbance in the child.

Further investigations needed

The Danish Health and Medicines Authority and the European drug regulatory authorities are currently assessing the safety of paracetamol use during pregnancy, and the results of the new Danish study will form part of the analysis together with the other knowledge in the area.

Results of the study

The cohort study involved 64,000 pregnant women from the Danish National Birth Cohort during 1996-2002. The results showed that children whose mothers used paracetamol during pregnancy were at a slightly higher risk of receiving a diagnosis of hyperkinetic disorders like ADHD, using ADHD medications, or having ADHD-like behaviours at the age of 7. Higher risk was observed, the longer the mother had used paracetamol during pregnancy.

The Danish study is a major and well-designed study, but due to the limitations of this type of study, it is not possible to make conclusions about the actual connection or whether other factors in women than the use of paracetamol during pregnancy may have influenced the results.