FDA Approves Amitiza for Irritable
Bowel Syndrome with Constipation IBS-C
The U.S. Food and Drug Administration approved on April 29, 2008 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.
The safety and efficacy of Amitiza was established in two major studies involving 1,154
patients diagnosed with IBS-C. The majority of the patients studied were women
(approximately 8 percent were men). Patients enrolled in the studies were experiencing at
least mild abdominal discomfort or pain that was associated with at least two of the following
additional symptoms: 1) fewer than 3 spontaneous bowel movements per week (that did not
result from laxative use); 2) hard stools; or 3) moderate or severe straining with bowel
movements. In the studies some patients received Amitiza and others were given a placebo.
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. The
safety of long term treatment was assessed in a study in which all patients were treated with
Amitiza for a duration that ranged 9 to 13 months.
The efficacy of Amitiza in men was not conclusively demonstrated for IBS-C. 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.
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.
Amitiza is not approved for use in children and men. It is not to be administered to patients
suffering from severe diarrhea or patients with known or suspected bowel obstructions. Its
safety and efficacy has not been established in patients with renal or hepatic impairment,
pregnant, or nursing mothers.
Amitiza is also approved for the treatment of chronic idiopathic constipation (CIC), but the
dose for that indication is higher, 24 micrograms twice a day.
Amitiza is manufactured by Sucampo Pharmaceuticals, Bethesda, MD, and will be jointly
marketed by Sucampo and Takeda Pharmaceuticals America, Inc., Deerfield, IL.
SOURCE FDA Approves Amitiza for IBS-C, Only drug available in United States for irritable
bowel syndrome with constipation, FDA website May 2008
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