Mesalamine Pregnancy and Breastfeeding Warnings
Mesalamine Pregnancy Warnings
Animal studies of mesalamine have failed to reveal evidence of fetal harm. However, dibutyl phthalate (DBP) is an inactive ingredient in the enteric coating of Asacol(R) and Asacol(R) HD tablets and in animal studies at doses greater than 190 and greater than 80 times the human dose based on body surface area, respectively, maternal DBP was associated with external and skeletal malformations and adverse effects on the male reproductive system. There are no controlled data in human pregnancy. Limited published data on mesalamine show no increase in the overall congenital malformations. Some data show an increased rate of preterm birth, stillbirth, and low birth weight; however, these adverse pregnancy outcomes are also associated with active inflammatory bowel disease. Mesalamine or 5-aminosalicylic acid (5-ASA) is known to cross the placenta. In six women, plasma concentrations of 5-ASA ranged from 0 to 3 mmol/L at delivery. Plasma concentrations in the newborn were 0.5 mmol/L or less. Plasma concentrations of N-acetyl-5-ASA were similar in the mothers and the newborns. In prospective and retrospective studies of more than 600 women exposed to mesalamine during pregnancy, the observed rate of congenital malformations was not increased above the background rate in the general population. Some data show an increased rate of preterm birth, stillbirth, and low birth weight, but it is not clear if this was due to underlying maternal disease, drug exposure, or both, as active inflammatory bowel disease is also associated with adverse pregnancy outcomes. Renal hyperchogenicity has occurred in one infant whose mother received oral mesalamine from the second through the fifth month of pregnancy. At six months of age, the infant demonstrated a creatinine clearance of 52 mL/min. A renal biopsy showed focal tubulointerstitial lesions characterized by the association of interstitial fibrosis and tubular atrophy in the absence of cell infiltration. FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women. 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.
FDA pregnancy category: B (mesalamine oral capsules, 1.2 g oral tablets [Lialda (R)], and rectal products) FDA pregnancy category: C (mesalamine 400 mg and 800 mg oral tablets [Asacol(R) and Asacol(R) HD]) Mesalamine should be used during pregnancy only if clearly needed and benefit outweighs potential risk.
Mesalamine Breastfeeding Warnings
Caution is recommended. Excreted into human milk: Yes Excreted into animal milk: Data not available Diarrhea has been reported in the nursing infant; other effects are unknown. The following should be considered: -The developmental and health benefits of human milk feeding -The mother's clinical need for mesalamine -Potential side effects in the human milk fed child due to the drug or the mother's underlying condition
Mesalamine and its N-acetyl metabolite are excreted into human milk. Watery diarrhea has been reported in a breastfed infant beginning 12 hours after the first dose of rectal mesalamine and persisting for 10 hours after the last dose. Several rechallenges reproduced the diarrhea in the infant. Following oral administration of mesalamine, the milk to plasma ratio ranges from 0.1 to 0.3. The milk to plasma ratio of N-acetyl-5-aminosalicylic acid ranges from 5.1 to 16.5. In published lactation studies, maternal mesalamine doses from various oral and rectal formulations and products ranged from 500 mg to 3 g daily. The concentrations of mesalamine and N-acetyl-5-aminosalicylic acid in milk ranged from nondetectable to 0.11 mg/L and 5 to 18.1 mg/L, respectively. Based on these concentrations, estimated infant daily doses for an exclusively breastfed infant are 0 to 0.017 mg/kg/day of mesalamine and 0.75 to 2.72 mg/kg/day of N-acetyl-5-aminosalicylic acid. Dibutyl phthalate, an inactive ingredient in the enteric coating of Asacol(R) and Asacol(R) HD tablets, and its primary metabolite mono-butyl phthalate are excreted into human milk. The clinical significance has not been established.
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