Important Safety Information
- Lialda tablets are indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. Safety and effectiveness of Lialda beyond 8 weeks have not been established.
- Lialda is contraindicated in patients with hypersensitivity to salicylates (including mesalamine) or to any of the components of Lialda. Caution should be exercised when treating patients with pyloric stenosis or those allergic to sulfasalazine. Mesalamine has been associated with an acute intolerance syndrome (3% of patients in clinical trials with mesalamine or sulfasalazine) that may be difficult to distinguish from a flare of inflammatory bowel disease. If acute intolerance syndrome is suspected, prompt withdrawal is required. Mesalamine-induced cardiac hypersensitivity reactions (myocarditis and pericarditis) have been reported. Reports of renal impairment have been associated with mesalamine medications. In patients with renal impairment, caution should be exercised, and Lialda should be used only if the benefits outweigh the risks. No information is available for patients with hepatic impairment.
- Lialda is generally well tolerated. The majority of adverse events in the double-blind, placebo-controlled trials were mild or moderate in severity. In clinical trials (N=535), the most common treatment-related adverse events with Lialda 2.4 g/day, 4.8 g/day and placebo were headache (5.6%, 3.4% and 0.6%, respectively) and flatulence (4%, 2.8% and 2.8%, respectively). Pancreatitis occurred in less than 1% of patients during clinical trials and resulted in discontinuation of therapy with Lialda.
