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

y also be allergic to Lialda or drugs that contain or are converted to mesalamine. Some patients taking Lialda or mesalamine-containing products have reported heart-related allergic reactions, such as inflammation of the heart muscle and inflammation of the lining of the heart.  Tell your doctor if you have or have had a history of myocarditis or pericarditis as this may predispose you to these types of reactions.  

Reports of liver failure have been associated with mesalamine-containing products like Lialda in patients that have or have had liver disease. Tell your doctor if you have a problem with your liver.

Tell your doctor if you have a stomach blockage, as this may delay the release of medication.

In clinical trials, common side effects reported with Lialda included ulcerative colitis, headache, gas, abnormal liver function test results, and stomach ache. Inflammation of the pancreas was reported which in some cases led to discontinuation of Lialda therapy. Other side effects may occur.  

Before starting Lialda, tell your doctor about all medications you are taking.  Mesalamine may increase the risk of kidney problems when used with non-steroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, naproxen). Mesalamine may increase the risk of blood disorders when used with azathioprine and 6-mercaptopurine.  

Please see Full Prescribing Information.

Additional information about Lialda is available at http://www.Lialda.com.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.FDA.gov/medwatch, or call 1-800-FDA-1088.

About Lialda

Lialda is indicated for the induction of remission in patients with active, mild to moderate ulcerative
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SOURCE Shire plc
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