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Class ⬇

Antibacterial (Antituberculosis)

PREGNANCY RECOMMENDATION:Limited Human Data—Animal Data Suggest Risk (Maternal Benefit May Outweigh Any Potential Embryofetal Risk)

BREASTFEEDING RECOMMENDATION:Probably Compatible

Pregnancy Summary ⬆ ⬇

Several studies have been located that describe the use of para-aminosalicylic acid during human pregnancy. With combined data from a few larger series, the congenital birth anomaly rate is slightly higher than the expected rate, but no pattern to the defects has been described. This finding may be related to the maternal disease state. The drug will probably cross the placenta, so some fetal exposure will likely occur. Therefore, this limited human pregnancy experience prevents a complete assessment of the embryofetal risk. Animal studies did show some embryofetal toxicity with malformations in two species at doses of about equal to the RHD. However, because tuberculosis (TB), especially multidrug-resistant TB, is a serious infection, withholding the drug because of pregnancy could have adverse consequences.

Breastfeeding Summary ⬆ ⬇

Para-aminosalicylic acid was found to be excreted into human breast milk. The breast milk level was about 1.1 mcg/mL, resulting in a calculated RID that was less than 1%. Due to a concern for potential serious adverse effects that might be seen in a breastfed infant, the manufacturer recommends that women not breastfeed while being treated with this drug. Nevertheless, breastfeeding while using this drug should be based on the mother’s clinical need for treatment versus any potential infant risks that might occur. If used, the infant should be monitored for the most common reported adult side effects of nausea (leading to irritability), diarrhea, vomiting, rash, and fever.

Reference ⬆

  1. Prescribing Information. Paser. Jacobus Pharmaceutical; 2010.
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