FDA OKs Constipation Drug for IBS
FDA Approves Amitiza for Use in Women With Irritable Bowel Syndrome With Constipation
WebMD News Archive
April 30, 2008 -- The FDA has approved the use of the constipation drug Amitiza to
treat irritable bowel syndrome with
constipation (IBS-C) in women aged 18 and older.
Amitiza is the first FDA-approved prescription drug therapy for IBS-C. But
it isn't a new drug. The
FDA approved Amitiza in 2006 to treat chronic constipation in adults. The
Amitiza dose used to treat IBS-C is lower than the dose used to treat chronic
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, and it affects at least twice as
many women as men.
Amitiza works by increasing the secretion of intestinal fluid, which helps
ease stool passage and constipation symptoms.
"For some people, IBS can be quite disabling, making it difficult for
them to fully participate in everyday activities," Julie Beitz, MD,
director for the Office of Drug Evaluation III at the FDA's Center for Drug
Evaluation and Research, says in a news release. "This drug represents an
important step in helping to provide medical relief from their
The FDA approved Amitiza's use for treating IBS-C in women based on two
studies involving 1,154 patients diagnosed with IBS-C, most of whom were
The patients either got Amitiza or a placebo pill. More patients in the
Amitiza group than in the placebo group reported that their irritable bowel
syndrome symptoms were moderately or significantly relieved over a 12-week
The FDA didn't approve Amitiza for use in men. "The efficacy of Amitiza in men was not
conclusively demonstrated for IBS-C," says an FDA news release.
Amitiza also isn't approved for use in children, and it shouldn't be given
to patients who have severe diarrhea or known or suspected bowel obstructions.
Amitiza's safety and efficacy haven't been established in pregnant women, nursing mothers,
or patients with kidney or liver problems.
Amitiza's common side effects include nausea, diarrhea, and abdominal
pain. Other rare side effects include urinary tract infections, dry mouth,
fainting, swelling of the extremities, breathing problems, and heart palpitations.
The FDA recommends that Amitiza be taken with food and water twice daily in 8 microgram doses to treat IBS-C.
Doctors and patients should periodically assess the need for continued
Amitiza is co-marketed by Sucampo
Pharmaceuticals and Takeda Pharmaceuticals North America. Clinical trials are
under way to test Amitiza for constipation in pediatric patients, people with
liver problems, and treatment of opioid-induced bowel dysfunction.