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SMFM issued a recent statement regarding
the safety and use of acetaminophen in pregnancy “The SMFM continues to advise
that acetaminophen be considered a reasonable and appropriate medication choice
for the treatment of pain and/or fever during pregnancy.” Few recent
observational studies documented a causal relationship between its use in pregnancy
and increased risk of childhood neurodevelopmental disorders in offspring.
The statement was published online in [1]American
Journal of Obstetrics and Gynecology.
Acetaminophen is the most commonly
used over the counter (OTC) drugs in US for minor aches and pains, and lower fever in pregnancy. A survey estimates that nearly 40-65% of women use
Acetaminophen sometimes in pregnancy. In US, the most common brand name is
Tylenol.
Two retrospective cohort studies
published last year and 3 other similar studies published in 2013-2014 have
reported mild association between the drug use and adverse neurological
outcomes.
The various neurological disorders that
were reported to occur in these studies were ADHD, psychotic symptoms, schizophrenia and autistic
spectrum disorder(ASD) with a hyperkinetic disorder.
US-FDA evaluated all these studies in
2015 and issued a statement ““Based on our evaluation of these studies, we
believe that the weight of evidence is inconclusive regarding a possible
connection between acetaminophen use in pregnancy and ADHD in children.”
FDA further stated that these studies have
inherent flaws in study designs. All studies were retrospective in nature and
suffered from recall bias, interview bias and inability to control for all the
confounders. The diagnosis of ADHD is still evolving and other prenatal and postnatal
environmental and genetic factors also play a role in its causation.
Hence, the current evidence is
inconclusive to establish causality. But, all medication should be taken in
pregnancy keeping in mind the risk- benefit ratio. The healthcare providers
should caution all patients regarding the safety of OTC drugs in pregnancy.
The full text of the journal article
can be accessed here.
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