Label Changes for:
Asacol (mesalamine) 400 mg delayed-release tablets
September 2009
Changes have been made to the PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- September 2009
PRECAUTIONS
Use in Hepatic Impairment
- There have been reports of hepatic failure in patients with pre-existing liver disease who have been administered mesalamine. Caution should be exercised when administering Asacol to patients with liver disease.
Information for Patients
- (reworded) taking care not to break cut, or chew the tablets, because the coating is an important part of the delayed-release formulation.
