Business Report

SAHPRA reassures public on safety of paracetamol use during pregnancy

Staff Reporter|Published

The South African Health Products Regulatory Authority (SAHPRA) reassures expectant mothers that paracetamol is safe for managing pain and fever during pregnancy, provided it is used at recommended doses and for a short duration.

In discussing the critical role of this widely used medication, Dr Boitumelo Semete-Makokotlela, CEO of SAHPRA, noted, “Paracetamol is one of the most widely used medicines globally and has been extensively studied for decades. There is currently no scientific evidence that using paracetamol in pregnancy causes attention-deficit hyperactivity disorder (ADHD) and autism.”

Semete-Makokotlela emphasised the importance of informed decision-making for pregnant women. “Paracetamol remains a recommended safe treatment for pain or fever in pregnant women. Pregnant women should be reassured that there is no evidence that taking paracetamol during pregnancy causes autism or ADHD in children,” she added, underscoring the urgency of proper medical guidance.

The SAHPRA has advised that pregnant women and those planning a pregnancy should utilise paracetamol only when necessary, ensuring to use the lowest effective dose for the shortest duration possible.

The authority also highlights that untreated fever and pain can pose risks to the unborn baby and encourages mothers-to-be to seek treatment if pain or fever persists or if any concerns arise regarding medicine use during pregnancy. It is also advised that pregnant women refrain from combining paracetamol with other medications without prior consultation with a healthcare professional.

Further validation of SAHPRA's position comes from findings published by the South African Society of Obstetricians and Gynaecologists (SASOG), the Society of Obstetric Medicine South Africa (SOOMSA), and the South African Society for Ultrasound in Obstetrics and Gynaecology (SASUOG).

These organisations conducted an extensive review of existing evidence, including large cohort studies and sibling-controlled analyses, corroborating that there is no evidence to support claims that paracetamol use during pregnancy leads to autism.

Although some early observational studies hinted at a correlation between prenatal paracetamol exposure and autism spectrum disorder (ASD), experts clarified that these analyses were fraught with confounding variables, where factors such as genetics, family history, and environmental triggers played significant roles in the observed outcomes.

Notably, more robust studies, including a Swedish population-based study, demonstrated that when familial factors were accounted for, the alleged association between paracetamol use and ASD dissipated.

As a precautionary measure, SAHPRA further encourages healthcare professionals and the public to report any suspected adverse drug reactions (ADRs) related to paracetamol and other health products.

Saturday Star