Sucampo has accepted the following FDA-approved labeling changes, which will be effective immediately:
- All pregnancy-related Warnings and Precautions (Section 5.1 of the label) have been removed. This includes deletion of the sentence: “Women who could become pregnant should have a negative pregnancy test prior to beginning therapy with AMITIZA and should be capable of complying with effective contraceptive measures.”
- Section 8 of the product labeling, “Use in Specific Populations,” was updated to include additional animal data and a Clinical Consideration section, with the pregnancy category remaining unchanged.
- Previous labeling 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 (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.”
A recent study suggests that one of the contributing factors to abdominal pain in IBS may be increased intestinal permeability induced by disruption of the tight junctions. It has been previously established that activation of the ClC-2 chloride channel specifically, but not CFTR chloride channel, mediates reduction in intestinal permeability. Lubiprostone is the only product approved for use in IBS-C which includes a mechanism of action for reducing intestinal permeability.
About AMITIZA (lubiprostone) for Chronic Idiopathic Constipation (CIC) and Irritable Bowel Syndrome with Constipation (IBS-C)AMITIZA is a chloride channel activator indicated for the treatment of CIC (24 mcg twice daily) in adults and for IBS-C (8 mcg twice daily) in women 18 years of age and older.
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