Sucampo announced that it has received a supplement approval from the FDA that removes pregnancy “warnings and precautions” and clarifies information regarding the use of Amitiza (lubiprostone) by pregnant and/or nursing women. Also, the FDA expanded the labeling text of the mechanism of action section.
The following FDA-approved labeling changes are to take effect immediately:
- All pregnancy-related “Warnings and Precautions” (Section 5.1) have been removed.
- “Use in Specific Populations” (Section 8) was updated to include additional animal data and a Clinical Consideration section, with the pregnancy category remaining unchanged.
- Previous statements regarding the potential for serious adverse reactions in nursing infants have been removed. The revised label states that caution should be exercised when Amitiza is administered to a nursing mother and advises “lactating women to monitor their human milk-fed infants for diarrhea while taking Amitiza.”
- The “Mechanism of Action” (Section 12.1) of the label now reads as follows: “Lubiprostone is a locally acting chloride channel activator…activation of ClC-2 by lubiprostone has been shown to stimulate recovery of mucosal barrier function and reduce intestinal permeability (bolding added to indicate label addition) via the restoration of tight junction complexes in ex vivo studies of ischemic porcine intestine.”
Amitiza is a chloride channel activator indicated for the treatment of chronic idiopathic constipation (CIC) in adults and irritable bowel syndrome with constipation (IBS-C) in women >18 years of age.
For more information call (888) 9-AMITIZA or visit www.amitiza.com.