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FDA Approves Delzicol for the Treatment of Ulcerative Colitis

Delzicol (Mesalamine) Capsules To Replace Asacol Tablets

Warner Chilcott recently announced that the FDA has approved its new product, Delzicol (mesalamine), for the treatment of mildly to moderately active ulcerative colitis (UC) and for the maintenance of remission of UC.

Delzicol, a delayed-release 400-mg capsule, contains the same active ingredient and works in the same way as Asacol, which also is indicated for the treatment and maintenance of remission of UC. Delzicol offers the same efficacy and safety profile as Asacol, but comes in a capsule formulation. (Asacol was formulated as a tablet but is no longer being manufactured, according to the product website.)

According to the Delzicol website, “patients (N=331) preferred capsules versus coated and uncoated tablets of the same size and shape; capsules were also perceived as easier to swallow compared to tablets” (www.delzicol.com).

Common adverse effects associated with Delzicol include stomach pain, diarrhea, constipation, headache, back pain, tiredness, vomiting and fever. Reports of liver failure also have been associated with mesalamine-containing products like Delzicol in patients who have or have had liver disease, according to the safety information issued by Warner Chilcott. Mesalamine also may increase the risk for kidney problems when used with nonsteroidal anti-inflammatory drugs and may increase the risk for blood disorders when used with azathioprine and 6-mercaptopurine.

 

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