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Experts raise caution over paracetamol in pregnancy warning


Matt Woodley


28/09/2021 4:22:31 PM

The research suggests prenatal exposure to paracetamol could increase the risk of neurodevelopmental, reproductive and urogenital disorders.

Pregnant patient taking paracetamol
Paracetamol is one of the few available drugs that can be used to reduce fever in pregnancy.

The authors of a new Consensus Statement published in Nature Reviews Endocrinology have called for a focused research effort to study how paracetamol affects foetal development and proposed that precautionary measures be taken in the meantime.
 
The call follows a review of research related to paracetamol use during pregnancy that reportedly suggests prenatal exposure to paracetamol may affect foetal development, which might increase the risk of certain neurodevelopmental, reproductive and urogenital disorders.
 
To form their conclusions, the paper’s authors reviewed experimental animal and cell-based research, and human epidemiological research related to paracetamol use during pregnancy published between 1 January 1995 and 25 October 2020.
 
However, Dr Alex Polyakov from the Department of Obstetrics and Gynaecology at the University of Melbourne believes ‘several points’ need to be made in relation to the review’s findings and recommendations.
 
‘Importantly, [the paper] does not contain any new research findings but rather a review of the currently available evidence,’ he said.
 
‘It is possible and even likely that paracetamol, if used in excessive quantities and for a long period of time during pregnancy, may have undesirable consequences for the offspring.
 
‘[But] it must be noted that treating fever and pain during pregnancy is challenging, since most other therapeutic options have significantly higher proven risks compared to paracetamol. The current recommendation for all medications used in pregnancy is to utilise them judiciously, for specific indications, at the lowest possible effective dose and for the shortest period of time.
 
‘These general principles certainly apply to paracetamol.’
 
Dr Ian Musgrave, a Senior Lecturer in the Faculty of Medicine at the University of Adelaide, formed a similar conclusion.
 
‘We should be periodically re-evaluating medicine safety, especially drugs for pregnancy, since the developing child is vulnerable,’ he said.
 
‘However, we should also be careful not to unduly cause anxiety, and the use of any drug is a balance of benefits versus potential harms.
 
‘For example, fever is an accepted risk factor for harm to the developing child, and paracetamol is one of the few available drugs that can be used to reduce fever in pregnancy.’
 
While the recommendations suggested by the authors do not differ substantially from current general pregnancy medication advice, they believe that paracetamol-specific risk communication is warranted to both health professionals and those who are pregnant because of the high rates of use and perceptions of negligible risk.
 
But Dr Polyakov says the studies used to form these conclusions are also open to interpretation and in many cases possess flaws.
 
‘There are numerous reports that support the notion that paracetamol may act as an endocrine disrupting compound and lead to various abnormalities in animals, mostly rodents,’ he said.
 
‘The main limitation of these studies is that rodents are not human and have different physiology, and therefore applying these findings to humans must be made with caution.
 
‘It is also worth noting that studies done in animals commonly use high doses of the drug under study, often an order of magnitude higher than is typically used in humans.
 
‘Therefore, while animal studies may demonstrate an adverse outcome and may help explain its mechanism, they are usually not directly translatable to humans.’
 
Dr Musgrave also said the observational studies utilised in the review are difficult to interpret.
 
‘While they are suggestive, the same effects have been variously attributed to other environmental influences, from Perfluoroalkyl substances to a range of other environmental endocrine disruptions,’ he said.
 
‘Teasing out any effect of paracetamol will require new studies, as the authors suggest. Again, as with the animal studies, not all the studies show the same effects.
 
‘With the current evidence, judicious use of paracetamol is warranted. As always however, [patients] should discuss any concerns with their physicians.’
 
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Dr Alan Robert McLean   29/09/2021 9:19:39 AM

Clinicians prescribe drugs in pregnancy based on the ABCD classification of drug safety: This system is robust. I assume there is not immediate challange to Paracetamol's category A status?