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Cefoxitin Pregnancy and Breastfeeding Warnings

Brand names: Mefoxin

Medically reviewed by Drugs.com. Last updated on Feb 16, 2024.

Cefoxitin Pregnancy Warnings

Use is recommended only if clearly needed and the benefit outweighs the risk.

AU TGA pregnancy category: B1
US FDA pregnancy category: Not assigned.

Risk Summary: Malformative risk with use of this drug in pregnant women is unlikely.

Animal studies have failed to reveal evidence of fetotoxicity, fetal harm, or teratogenicity at doses up to 7.5 times the maximum recommended human dose; however, there was increased incidence of abortion at levels reaching maternal toxicity. There are no controlled data in human pregnancy.

AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Cefoxitin Breastfeeding Warnings

Caution is recommended.

Excreted into human milk: Yes

Comments:
-The American Academy of Pediatrics considers this drug as compatible with breastfeeding.
-Maternal doses of cephalosporins have resulted in reports of neonatal diarrhea and thrush.
-Some experts state that patients should consider alternative feeding arrangements for infants.

See references

See also

References for pregnancy information

  1. (2002) "Product Information. Mefoxin (cefoxitin)." Merck & Co., Inc
  2. Cerner Multum, Inc. "Australian Product Information."
  3. TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee (2010) Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregnancy. http://www.tga.gov.au/docs/html/medpreg.htm

References for breastfeeding information

  1. (2002) "Product Information. Mefoxin (cefoxitin)." Merck & Co., Inc
  2. Cerner Multum, Inc. "Australian Product Information."
  3. United States National Library of Medicine (2013) Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
  4. Briggs GG, Freeman RK. (2015) "Drugs in Pregnancy and Lactation." Philadelphia, PA: Wolters Kluwer Health

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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