Ethambutol Pregnancy and Breastfeeding Warnings
Brand names: Myambutol
Medically reviewed by Drugs.com. Last updated on Apr 5, 2024.
Ethambutol Pregnancy Warnings
This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.
AU TGA pregnancy category: A
US FDA pregnancy category: C
Animal studies have revealed evidence of teratogenicity (cleft palate with/without hare lip, exencephaly, monophthalmia, shortened right forearm with bilateral wrist joint contracture, vertebral column abnormalities, including minor abnormalities of the cervical vertebra) when given high doses during pregnancy. A slight but not significant (P greater than 0.05) increase in fetal mortality, decrease in fertility, and decrease in litter size were observed. There are no controlled data in human pregnancy.
AU TGA pregnancy category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.
US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Ethambutol Breastfeeding Warnings
The WHO recommends stopping or changing the drug (if possible) in breastfed infants who develop significant jaundice. Artificial/formula feedings should be considered if this is not possible.
Benefit should outweigh risk.
Excreted into human milk: Yes
Comments:
-The WHO considers this drug compatible with breastfeeding; breastfed infants should be monitored for jaundice.
-The American Academy of Pediatrics considers this drug compatible with breastfeeding.
-The US Centers for Disease Control and Prevention, Infectious Diseases Society of America, American Thoracic Society, and the National Foundation for Infectious Diseases recommend that breastfeeding not be discouraged in women taking this drug.
See also
References for pregnancy information
- Product Information. Myambutol (ethambutol). Lederle Laboratories. 2002;PROD.
- Cerner Multum, Inc. Australian Product Information.
- TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee. Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregnancy. http://www.tga.gov.au/docs/html/medpreg.htm 2010.
References for breastfeeding information
- Product Information. Myambutol (ethambutol). Lederle Laboratories. 2002;PROD.
- American Academy of Pediatrics. Red Book Online. http://aapredbook.aappublications.org/ 2013.
- United States National Library of Medicine. Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT 2013.
- Department of Adolescent and Child Health and Development. UNICEF. World Health Organization. Breastfeeding and maternal medication: recommendations for drugs in the eleventh Who model list of essential drugs. http://whqlibdoc.who.int/hq/2002/55732.pdf?ua=1 2014.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
