Can you take olsalazine while breastfeeding?

What LactMed would consider instead

LactMed ends this record by naming the drugs it would consider in place of olsalazine. Whether any of them fits depends on what you are treating — this is the database’s list, not a recommendation from us.

• Adalimumab
• Azathioprine
• Budesonide
• Certolizumab Pegol
• Infliximab
• Mesalamine
• Prednisone
• Sulfasalazine

How much olsalazine gets into breastmilk

Olsalazine is a prodrug that liberates the active drug, mesalamine (5-aminosalicylic acid; 5-ASA), in the gastrointestinal tract. Mesalamine is metabolized to N-acetyl-5-ASA, which is inactive in treating inflammatory bowel disease, but its possible effects on the breastfed infant are unknown.

Maternal Levels. A lactating woman with a long history of Crohn's disease and 2 bowel resections at her terminal ileum was given a single oral dose of olsalazine 500 mg at 4 months postpartum. She was also taking prednisone 17.5 mg daily at the time of the study. Milk samples were taken periodically from 30 minutes to 48 hours after the dose. Olsalazine and its metabolites, olsalazine sulfate and mesalamine were undetectable (<170 mcg/L) in milk at all times during the study. The inactive mesalamine metabolite, N-acetyl-5-ASA, was detectable only at 10, 14 and 24 hours after the dose in concentrations of 170, 183 and 264 mcg/L, respectively.

A woman taking olsalazine capsules 750 mg twice daily collected 5 breastmilk samples over one day at 2 to 4 weeks postpartum. Mesalamine was undetectable (<20 mcg/L) in milk. N-acetyl-5-ASA averaged 2.3 mg/L (range 1.2 to 3.8 mg/L) in the 5 samples. The highest milk level was in the 6 pm sample, but the times of the doses were not stated.

Infant Levels. Relevant published information was not found as of the revision date.

What has been seen in breastfed infants

One infant was breastfed during maternal therapy with olsalazine for Crohn's disease. After 2 and 3 weeks of therapy, no rash, wheezing, vomiting or diarrhea were noted in the infant.

The active metabolite of olsalazine, mesalamine, was probably responsible for diarrhea in a 6-week-old whose diarrhea recurred 4 times after rechallenging the mother 4 times during breastfeeding.

In a prospective telephone follow-up study, 8 nursing mothers reported taking mesalamine (dosage and route unspecified). One mother reported diarrhea in her infant. No other adverse reactions were reported in the infants by their mothers.

A case-control study compared the infants of mothers taking mesalamine (n = 117; average dose, 2065 mg daily), olsalazine (n = 2) or sulfasalazine (n = 2) to infants of matched control mothers (n = 121) who were exposed to no treatment known to be harmful to a breastfed infant. Infants were exposed to mesalamine through milk for a mean of 5.3 months (range: 3 days-24 months). Infants were breastfed for an average of about 7.4 months and were followed up at an average age of about 22 months. No difference in the frequency or characteristics of maternally reported adverse events were found between exposed and control infants.

Effects on milk supply

Relevant published information was not found as of the revision date.