EU regulator: paracetamol can be used in pregnancy

The European Medicines Agency (EMA) has released a statement designed to clear up any remaining uncertainty about the use of paracetamol. In the EU, the drug watchdog says, paracetamol (also known as acetaminophen) can be used for reducing pain or fever during pregnancy if clinically needed.

There is no new evidence that would require changes to the current long-standing recommendation, the Agency stressed. It cited a recent systematic review and meta-analysis published in The Lancet Obstetrics, Gynaecology & Women’s Health which found no evidence linking paracetamol to autism, ADHD or intellectual disability in children.

‘Paracetamol remains an important option to treat pain or fever in pregnant women,’ said EMA’s Chief Medical Officer, Steffen Thirstrup. ‘Our advice is based on rigorous assessment of the available scientific data and we have found no evidence that taking paracetamol during pregnancy causes autism in children.’

The unusual decision to issue a statement – which announces no change in advice and no new evidence to review – comes in response to misinformation which falsely linked the common pain reliever with developmental changes. This idea was repeated by senior politicians in the United States in recent months, sparking widespread concern worldwide.

Without naming those who have perpetuated the myth, the EU regulator pushed back against the baseless medical claim which has potential to cause distress and avoidable physical suffering for pregnant women with a fever.

The EMA said it has a large amount of data from pregnant women who used paracetamol during pregnancy, over a very long period of time, and has seen no evidence of any risk of malformations in the developing foetus or in newborns.

‘When needed, paracetamol can be used during pregnancy. As with any medicine for acute treatment, it should be used at the lowest effective dose, for the shortest possible time and as infrequently as possible,’ the EMA statement said. ‘Pregnant women should speak to their healthcare professional if they have questions about any medication during pregnancy.’