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Consumer Update |
On April 29, 2008, the Food and Drug Administration (FDA) approved Amitiza (lubiprostone) for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in adult women aged 18 and over. With this approval, Amitiza becomes the only FDA-approved medical treatment for IBS-C available in the United States.
As a treatment for IBS-C, Amitiza should be taken twice a day in 8 microgram doses with food and water. Patients and their health care professionals should periodically assess the need for continued therapy.
The safety and effectiveness of Amitiza were established in two major studies involving 1,154 patients diagnosed with IBS-C. Most of the patients studied were women (approximately 8% were men). The effectiveness of Amitiza in men was not conclusive for IBS-C. More patients treated with Amitiza reported that their IBS symptoms were moderately or significantly relieved over a 12-week treatment period than patients who received placebo (inactive substance).
Common side effects of Amitiza include nausea, diarrhea, and abdominal pain. Other rare side effects include urinary tract infections, dry mouth, fainting (syncope), swelling of the extremities (peripheral edema), difficulty breathing (dyspnea), and heart palpitations.
Amitiza is manufactured by Sucampo Pharmaceuticals, Bethesda, Md., and Takeda Pharmaceuticals America, Inc., Deerfield, Ill.
FDA Press Release
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01828.html
Irritable Bowel Syndrome
http://digestive.niddk.nih.gov/ddiseases/pubs/ibs/
Date Posted: May 1, 2008