The US Food and Drug Administration (FDA) has approved prucalopride tablets for adults with chronic idiopathic constipation (CIC). CIC affects roughly 35 million adults in the United States. Prucalopride, a selective serotonin–4 (5-HT4) receptor agonist, enhances bowel motility by stimulating colonic peristalsis. The most common adverse reactions with prucalopride are headache, abdominal pain, nausea, diarrhea, abdominal distension, dizziness, vomiting, flatulence, and fatigue. Overall, discontinuation due to adverse events was low (5% with prucalopride 2 mg once daily vs 3% with placebo).
Cardiovascular safety was evaluated in the double-blind, placebo-controlled and open-label studies and in a retrospective observational study. The results showed no increase in the risk for major adverse cardiovascular events with prucalopride relative to polyethylene glycol. In clinical trials, suicides, suicide attempts, and suicidal ideation have been reported. A causal association between treatment with prucalopride and an increased risk for suicidal ideation and behavior has not been established.
Prucalopride is contraindicated in patients with a history of hypersensitivity to the drug. It is also contraindicated in patients with intestinal perforation or obstruction due to structural or functional disorder of the gut wall; obstructive ileus; severe inflammatory conditions of the intestinal tract, such as Crohn’s disease; ulcerative colitis; and toxic megacolon/megarectum.