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Mesalamine Pregnancy and Breastfeeding Warnings

Mesalamine is also known as: Apriso, Asacol, Asacol HD, Canasa, Canasa Pac, FIV-ASA, Lialda, Mesasal Enteric Coated, Pentasa, Rowasa, Rowasa Sulfite Free, Salofalk

Overview

If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Mesalamine Controlled-Release Capsules while you are pregnant. Mesalamine Controlled-Release Capsules are found in breast milk. If you are or will be breast-feeding while you use Mesalamine Controlled-Release Capsules, check with your doctor. Discuss any possible risks to your baby.

Mesalamine Pregnancy Warnings

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.

Mesalamine oral capsules, 1.2 g oral tablets [Lialda (R)], and rectal products have been assigned to pregnancy category B by the FDA. Mesalamine 400 mg and 800 mg oral tablets [Asacol (R) and Asacol HD (R)] have been assigned to pregnancy category C by the FDA. 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 HD (R) 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 is only recommended for use during pregnancy when benefit outweighs risk.

Mesalamine Breastfeeding Warnings

Mesalamine and its N-acetyl metabolite are excreted into human milk. Dibutyl phthalate, an inactive ingredient in the enteric coating of Asacol (R) and Asacol HD (R) tablets, and its primary metabolite mono-butyl phthalate are also 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. The manufacturer recommends that caution be used when administering mesalamine to nursing women.

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. The clinical significance of the excretion of dibutyl phthalate and mono-butyl phthalate into human milk has not been established.

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