The Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Amitiza (lubiprostone; Sucampo and Takeda) for the addition of two adverse reactions: syncope and hypotension.
Cases of syncope and hypotension have been reported with Amitiza in the postmarketing setting. Most cases have occurred in patients taking 24mcg twice daily and some occurred within an hour after taking the first dose or subsequent doses. The new label addition states that syncope and hypotension generally resolved following Amitiza discontinuation or prior to next dose, but recurrence has been reported with subsequent doses. Several cases reported concomitant use of medications known to lower blood pressure, which may increase the risk for the development of syncope or hypotension. Clinicians are advised to make patients aware of the risk; side effects such as diarrhea and vomiting may increase the risk for syncope and hypotension.
Amitiza, a chloride channel activator, is indicated to treat chronic idiopathic constipation in adults, opioid-induced constipation (OIC) (with some limitations) in adults with chronic non-cancer pain, and irritable bowel syndrome with constipation in women ≥18 years old.
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