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Prucalopride in chronic constipation: poorly documented risks

FEATURED REVIEW In women complaining of chronic constipation, prucalopride appears to have more risks than benefits: its modest efficacy must be weighed against poorly documented risks, including possible cardiovascular adverse effects and teratogenicity. Prucalopride should simply be avoided in the treatment of constipation, a troublesome but not life-threatening disorder.
Full review (4 pages) available for download by subscribers.


  • Constipation is a frequent complaint, especially in women and the elderly. It is sometimes drug-induced, and is only occasionally secondary to a functional or organic disorder. The risks associated with constipation are often overestimated.
  • Prucalopride, a 5-HT4 serotonin receptor agonist, chemically related to some neuroleptics, has been authorised in the European Union for symptomatic treatment of chronic constipation in women dissatisfied with laxatives.
  • A combined analysis of 3 randomised double-blind trials in a total of 1999 patients (87.9% women) complaining of chronic constipation showed that about 36% of women considered it effective at a dose of 2 or 4 mg/day, versus 18% of women receiving placebo. Normal bowel movements resumed in respectively 23.6% and 24.7% of patients taking 2 and 4 mg/day prucalopride, versus 11.3% of patients on placebo (p<0.001). No statistically significant difference was found between the 2 doses of prucalopride.
  • Palpitations were more frequent in patients treated with prucalopride. The incidence of ischaemic cardiovascular events was 0.2% with prucalopride versus 0.1% with placebo. Increases in heart rate and blood pressure were observed in pigs and dogs treated with prucalopride.
  • Prucalopride seems to increase prolactin levels. Tumours of the liver and thyroid were observed in rats. 
  • Prucalopride also carries a risk of poorly defined pharmacokinetic and pharmacodynamic interactions. Prucalopride may reduce the efficacy of oral contraceptives.
  • Miscarriages were reported in clinical trials. Prucalopride should not be taken during pregnancy. In addition, all women of child-bearing age should use effective contraception while taking prucalopride.
  • In practice, prucalopride should be avoided. It is better to focus on lifestyle and behavioural changes, and rational use of laxatives.

©Prescrire 1 May 2011

"Prucalopride in chronic constipation: poorly documented risks" Prescrire Int 2011; 20 (116): 117-120. (Pdf, subscribers only)

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