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Drug Approved for Irritable Bowel Syndrome with Constipation

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.

IBS

• is a disorder characterized by cramping, abdominal pain, bloating, constipation, and diarrhea.
• causes a great deal of discomfort and distress.
• affects at least twice as many women as men.  

Amitiza Safety and Effectiveness

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).

Side Effects

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.

Who Should Not Take Amitiza?

• children and men
• patients suffering from severe diarrhea or patients with known or suspected bowel obstructions
• patients with kidney or liver impairment, pregnant women, or nursing mothers

Amitiza is manufactured by Sucampo Pharmaceuticals, Bethesda, Md., and Takeda Pharmaceuticals America, Inc., Deerfield, Ill.

For More Information

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

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