Medliorate

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IBS Drug Approved

Posted by medliorator on May 4, 2008

The Food and Drug Administration on Tuesday approved the first U.S. drug to treat irritable bowel syndrome with constipation (IBS-C) in adult women, a medicine marketed by Takeda Pharmaceutical Co and its developer, Sucampo Pharmaceuticals Inc.

The drug, Amitiza, was approved for women over 18 years old, but not for men, because its effectiveness was not conclusively demonstrated, the FDA said in a statement.

The safety and effectiveness of Amitiza was established in two studies involving 1,154 patients diagnosed with IBS-C, the agency said. More than 90 percent of patients in the studies were women.

The drug was found to have some side effects, such as nausea, diarrhea, and abdominal pain, the FDA said.

FDA approves irritable bowel drug [Reuters]

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