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Shire plc: Lialda® (Mesalamine) Now Approved in U.S. for Maintenance of Remission of Ulcerative Colitis
Date:7/18/2011

th 6, which was similar to that seen using the comparator, mesalamine delayed-release 1.6 g/day (n=336) administered as 0.8 g given twice daily (81.5%; 95% confidence interval for difference: -3.9%, 8.1%).

Safety of Lialda in the maintenance of remission of ulcerative colitis was evaluated in three studies, one being the six-month, double-blind, non-inferiority, comparator study and two being 12- to 14-month open-label studies. The most common adverse reactions with Lialda in the maintenance arms of these three trials were ulcerative colitis, headache, abnormal liver function test and abdominal pain. The most common severe adverse reactions were gastrointestinal disorders, most of which are consistent with symptoms associated with ulcerative colitis.

In 2007, Lialda gained FDA approval for the induction of remission in patients with active, mild to moderate ulcerative colitis as a result of two eight-week, placebo-controlled clinical studies demonstrating safety and effectiveness.

Important Safety Information

You should not take Lialda if you are allergic to salicylates (including mesalamine, aspirin, or aspirin-containing products) or to any of the ingredients of Lialda.  

Reports of problems with kidney function have been associated with mesalamine-containing products like Lialda. Tell your doctor if you have or have had problems with your kidneys. It is recommended that all patients have their kidney function checked before starting Lialda and periodically while on therapy.

Products that contain mesalamine, like Lialda, have been associated with a condition that may be difficult to distinguish from an ulcerative colitis flare-up. Symptoms include cramping, stomach ache, bloody diarrhea, fever, headache, and rash. If you experience any of these symptoms, talk to your doctor immediately. Your doctor may decide to discontinue your medication.  

Tell your doctor if you are allergic to sulfasalazine, as you ma
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SOURCE Shire plc
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