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First Drug Approved for IBS-C
(May 8, 2008) - The Food and Drug Administration (FDA) has given the OK to the first drug to treat irritable bowel syndrome with constipation. (Read about "Irritable Bowel Syndrome") FDA approved Amitiza (lubiprostone) for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in adult women aged 18 and over. There is currently no prescription drug therapy for IBS-C. With this approval, Amitiza becomes the only FDA-approved medical treatment for IBS-C available in the United States.
Irritable bowel syndrome is a disorder characterized by cramping, abdominal pain, bloating, constipation, and diarrhea. IBS causes a great deal of discomfort and distress to its sufferers. It affects at least twice as many women as men.
"For some people IBS can be quite disabling, making it difficult for them to fully participate in everyday activities," said Julie Beitz, M.D., director of the Office of Drug Evaluation III, Center for Drug Evaluation and Research, FDA. "This drug represents an important step in helping to provide medical relief from their symptoms."
Amitiza is not approved for use in children and men. The drug was approved only for women because the clinical trials that led to its approval did not involve enough men to show that it was effective in men.
Amitiza, like most prescription medications, is accompanied by some side effects. Common side effects of Amitiza include nausea, diarrhea and abdominal pain. Other rare side effects include urinary tract infections, dry mouth, syncope (fainting), peripheral edema (swelling of the extremities), dyspnea (difficulty breathing) and heart palpitations. (Read about "Urinary Tract Infections" "Oral Health" "Syncope")
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