Safety

Asacol (mesalamine) delayed release tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)  

May 2015

Summary View

USE IN SPECIFIC POPULATIONS

Pediatric Use section edited
  • The safety and effectiveness of Asacol in pediatric patients 5 to 17 years of age for treatment of mildly to moderately active ulcerative colitis have been established over a 6-week period. Use of Asacol in these age groups is supported by evidence from adequate and well controlled studies of Asacol in adults and a single study in 82 pediatric patients 5 to 17 years of age [see Adverse Reactions (6.1), Clinical Pharmacology (12.3), and Clinical Studies (14.1)].
  • The safety and effectiveness of Asacol for the maintenance of remission of mildly to moderately active ulcerative colitis in pediatric patients have not been established. Efficacy was not demonstrated in a randomized, double-blind 26-week trial of two dosage levels for maintenance of remission of mildly to moderately active ulcerative colitis initiated in 39 patients aged 5 to 17 years. Possible factors contributing to this outcome included the dose range studied and premature termination of the trial.

 

May 2010

Summary View

ASACOL

PRECAUTIONS

Pregnancy
  • Dibutyl phthalate (DBP) is an inactive ingredient in Asacol’s enteric coating. The human daily intake of DBP from the maximum recommended dose of Asacol tablets is about 21 mg
  • ... in animal studies at doses >190 times the human dose based on body surface area, maternal DBP was associated with external and skeletal malformations and adverse effects on the male reproductive system. Asacol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

 

ASACOL HD

USE IN SPECIFIC POPULATIONS

Pregnancy
  • Dibutyl phthalate (DBP) is an inactive ingredient in Asacol HD’s enteric coating. The human daily intake of DBP from the maximum recommended dose of Asacol HD tablets is about 48 mg.
  • ...in animal studies at doses >80 times the human dose based on body surface area, maternal DBP was associated with external and skeletal malformations and adverse effects on the male reproductive system. Asacol HD should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

 

Page Last Updated: 06/12/2015
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