Co-amoxiclav (Augmentin) is classified as FDA Pregnancy Risk Category B i.e., animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women. Augmentin package insert published in DailyMed states it should be used during pregnancy only if clearly needed.
The association between early maternal exposure to amoxicillin and oral clefts remains controversial. One study finds that amoxicillin use in early pregnancy may be associated with an increased risk of oral clefts. The same study did not find associations between first-trimester exposure to amoxicillin and the risk of most other major birth defects, such as cardiovascular system, central nervous system, gastrointestinal system, urinary system defects and musculoskeletal system defects.
A rational pharmacotherapy approach will be:
INDICATION: Does the mother have a condition for which co-amoxiclav is clearly indicated?
EFFICACY: Is co-amoxiclav shown to be effective for the diagnosed condition? What is the place of co-amoxiclav for the treatment of the condition?
SAFETY: What are the common side effects of co-amoxiclav? Are there safer alternatives for the management of the condition? For instance, amoxicillin vs co-amoxiclav?
COMPLIANCE: Is the mother able to take the prescribed course i.e., cost & convenience?
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Footnote (Medscape.com):
We all know to be cautious when prescribing antibiotics to women who are pregnant. A new CDC analysis looked at a commercial insurance database to assess this further.
Among almost 35,000 pregnant women treated for urinary tract infections (UTIs) in their first trimester, nearly 35% received nitrofurantoin and about 8% received trimethoprim-sulfamethoxazole (TMP/SMX).
This is despite recommendations that these antibiotics should be avoided during the first trimester unless there are no alternatives. Options thought to be safe during pregnancy are amoxicillin-clavulanate, cephalosporins, and Fosfomycin…
Further Footnote from MotherToBaby.com:
See the Q&As from Amoxicillin/Clavulanate factsheet here: https://mothertobaby.org/fact-sheets/amoxicillin-clavulanate/
References:
- DailyMed – AUGMENTIN – amoxicillin and clavulante potassium tablet, film coated AUGMENTIN – amoxicillin and clavulante potassium tablet [Internet]. [cited 2019 Jun 20]. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d567412a-e5ed-4c7f-90f0-ea3039786480
- Lin KJ, Mitchell AA, Yau W-P, Louik C, Hernández-Díaz S. Maternal Exposure to Amoxicillin and the Risk of Oral Clefts. Epidemiol Camb Mass. 2012 Sep;23(5):699–705.
- Avoid These Antibiotics in the First Trimester of Pregnancy [Internet]. Medscape. [cited 2019 Jun 20]. Available from: http://www.medscape.com/viewarticle/891799