Aminosalicylic acid Pregnancy and Breastfeeding Warnings
Brand names: Paser
Aminosalicylic acid Pregnancy Warnings
This drug should be used during pregnancy only if clearly needed.
US FDA pregnancy category: C
Animal studies have revealed evidence of embryotoxicity and occipital malformations when given doses within the human dose range. Patients given this drug and isoniazid have reported an increased number of chromosomal aberrations. There are no controlled data in human pregnancy.
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.
Aminosalicylic acid Breastfeeding Warnings
Breastfeeding is not recommended during use of this drug.
Excreted into human milk: Yes
Comments:
-The effects in the nursing infant are unknown.
-Exclusively breastfed infants, especially those under 2 months, should be monitored for gastrointestinal disturbances, hemolysis, hypokalemia, jaundice, and thrombocytopenia.
Following administration of a different preparation to 1 patient, the milk Cmax was 1 mcg/mL at a Tmax of 3 hours with a half-life of 2.5 hours, and the maternal Cmax was 70 mcg/mL at a Tmax of 2 hours.
See also
References for pregnancy information
- "Product Information. Paser D/R (aminosalicylic acid)." Jacobus Pharmaceutical Company
- Cerner Multum, Inc. "UK Summary of Product Characteristics."
References for breastfeeding information
- "Product Information. Paser D/R (aminosalicylic acid)." Jacobus Pharmaceutical Company
- Cerner Multum, Inc. "UK Summary of Product Characteristics."
- United States National Library of Medicine (2013) Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
