Photo: Together with a number of colleagues from Denmark and abroad, David Møbjerg Kristensen, head of research, has reviewed 25 years of research on the use of paracetamol during pregnancy.
Concerned researchers from a number of countries are now urging pregnant women to be careful when taking pain-relieving medication containing paracetamol. A high consumption of paracetamol could harm their unborn child, and therefore pregnant women should only take pain-relieving medicine in consultation with their doctor, and provided there is a good medical reason. This advice comes from an international expert group of 13 authors with 78 co-signatories, who have just published a review of the existing data. On this basis, they have made a number of recommendations for the area in the prestigious journal Nature Reviews Endocrinology.
David Møbjerg Kristensen, head of research at the Danish Headache Centre, is one of several researchers in the expert group from Rigshospitalet. He has been researching the area for many years, and he has helped read the many scientific publications on which the expert group has based its recommendations.
“Research across many countries shows a possible link between a high consumption of paracetamol and harm to the unborn child, for example abnormalities of the new-born’s genital organs and neurological diseases such as ADHD and autism. These studies are supported by animal and cell studies that demonstrate the same links. We’ve now learned so much that now we think that women should be better informed so they can choose or refuse paracetamol on an enlightened basis. Especially because studies indicate that many women don’t consider paracetamol as a ‘proper’ pharmaceutical,” said David Møbjerg Kristensen.
He points out that the review of research in the area by the expert group has enabled the European and the American drug authorities to assess whether there is a need for more rigorous warnings for pregnant women, for example visible labels on paracetamol packaging.
“As with any other medication, paracetamol can have adverse effects, and pregnant women should know about these,” said David Møbjerg Kristensen.
Half take paracetamol
Paracetamol consumption has been increasing for many years in Denmark, and previous studies of Danish women have shown that 40-50% of women take paracetamol during pregnancy.
“The current research does not provide a complete picture of when consumption of paracetamol is too high, but the more the foetus is exposed, the higher the risk of certain diseases. Therefore, it’s crucial that pregnant women follow the recommendations from the Danish Medicines Agency and only use the medicine if necessary: and for as short a time and at as low a dosage as possible. If women are in doubt, they should talk to their GP or a pharmacy,” said David Møbjerg Kristensen.
Some of the unanswered questions about paracetamol for pregnant women are described in the major ongoing COPANA research project at Rigshospitalet, in which pregnant women register their intake of over-the-counter drugs and are closely monitored during their pregnancy and after birth. The study was planned by paediatrician Casper Hagen from the Department of Growth and Reproduction at Rigshospitalet.
"We strongly agree that it’s important to inform the women as fully as possible about circumstances that have already been identified by the Danish Medicines Agency. It’s also important that we gather better and more detailed knowledge about the consequences for pregnant women of using paracetamol,“ said Casper Hagen.
Sometimes it’s the best alternative
In the overall assessment of paracetamol, it is also important to remember that, in some cases, it may be the best alternative to relieve pain and fever. Research shows that the potential risks of other types of pain-relieving medicine than paracetamol (e.g. NSAID drugs with ibuprofen) are likely to be higher.
“Research shows that fever or very severe pain can potentially in itself cause harm to an unborn child, and therefore there are good medical reasons for physicians to recommend that a pregnant woman take paracetamol,” said David Møbjerg Kristensen.
The researchers in the expert group have reviewed research related to using paracetamol during pregnancy in the period January 1995 to October 2020. They point out that there is a need for more studies to further examine the potential links between paracetamol and harm to the unborn child. However, research results are now so convincing that, on the basis of a prudency principle, the expert group recommend that pregnant women should be better informed about the potential risks.