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Olsalazine Pregnancy and Breastfeeding Warnings

Olsalazine is also known as: Dipentum

Olsalazine Pregnancy Warnings

Olsalazine has been assigned to pregnancy category C by the FDA. Animal studies have demonstrated reduced fetal weights, retarded ossifications, and immaturity of the fetal visceral organs when given to pregnant rats in doses 5 to 20 times the human dose. There are no controlled data in human pregnancy. Olsalazine is only recommended for use during pregnancy when benefit outweighs risk.

See references

Olsalazine Breastfeeding Warnings

There are no data on the excretion of olsalazine into human milk. The metabolite of olsalazine, acetyl-5-aminosalicylic acid has been detected in human milk. Harmful infant effects (diarrhea) have been observed when olsalazine was used during breastfeeding. Because of the potential for serious adverse effects in nursing infants, a decision should be made to discontinue nursing or discontinue administration of olsalazine, taking into account the importance of the drug to the mother.

In one study of a lactating woman given a single 500 mg dose of olsalazine, the parent compound and the metabolites olsalazine-S and 5-aminosalicylic acid were undetectable in breast milk for 48 hours after the dose. Acetyl-5-aminosalicylic acid was detected up to 24 hours.

One study mentioned vomiting in a breastfed infant as an adverse effect of olsalazine. No other details were given.

See references

References for pregnancy information

  1. "Product Information. Dipentum (olsalazine)." Pharmacia and Upjohn, Kalamazoo, MI.

References for breastfeeding information

  1. "Product Information. Dipentum (olsalazine)." Pharmacia and Upjohn, Kalamazoo, MI.
  2. Wright JP, O'Keefe EA, Cuming L, Jaskiewicz K "Olsalazine in maintenance of clinical remission in patients with ulcerative colitis." Dig Dis Sci 38 (1993): 1837-42
  3. Miller LG, Hopkinson JM, Motil KJ, Corboy JE, Andersson S "Disposition of olsalazine and metabolites in breast milk." J Clin Pharmacol 33 (1993): 703-6

Further information

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