Drugs in Pregnancy

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SD -

....we don't use NSAIDs to treat babies until 6 months... has this changed?

Sean N. -

Hi SD,

Thank you for the comment

The FDA approved use of ibuprofen is for > 6 months of age for concerns of adverse effects in children less than 6 months of age eg, renal failure, Reye’s syndrome, gastrointestinal effects

We were not recommending use of ibuprofen in patients less than 6 months of age

We were referring to ibuprofen in breast feeding where ibuprofen is considered safe in breast feeding based on low levels in breastmilk according to Drugs and Lactation Database (LactMed) of the National Library of Medicine https://www.ncbi.nlm.nih.gov/books/NBK500986/

There are some studies evaluating ibuprofen in children less than 6 months of age and suggest it may be safe (see below)

However, we are not recommending using ibuprofen in this age group less than 6 months of age unless directed by pediatrician or neonatologist for specific reasons

Walsh P, Rothenberg SJ, Bang H. Safety of ibuprofen in infants younger than six months: A retrospective cohort study. PLoS One. 2018 Jun 28;13(6):e0199493. doi: 10.1371/journal.pone.0199493. PMID: 29953460; PMCID: PMC6023220

Ziesenitz VC, Zutter A, Erb TO, van den Anker JN. Efficacy and Safety of Ibuprofen in Infants Aged Between 3 and 6 Months. Paediatr Drugs 2017 Aug;19(4):277-290. doi: 10.1007/s40272-017-0235-3. PMID: 28516288

Thank you for the comment

Sean Nordt

Kimmie Won

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CorePendium Spotlight: Drugs in Pregnancy Full episode audio for MD edition 9:34 min - 12 MB - M4A