In November 2002, alosetron HCl (Lotronex, GlaxoSmithKline Research Triangle Park, NC, USA) was re-introduced to the US marketplace for women with severe diarrhoea-predominant irritable bowel syndrome. In support of the re-introduction, a risk management programme was implemented, which included a patient follow-up study in which all users of alosetron could participate. We report on the methods used and the effectiveness of key elements of the risk management programme. Patients voluntarily enroled in the study and completed questionnaires at baseline, after 5 and 10 weeks, and quarterly thereafter. Questions focussed on patient eligibility, knowledge of risks and benefits, and adherence to the recommended programme elements for education, prescribing and dispensing. Between December 2002 and 2004, 4803 patients enrolled in the study, and < 3% were lost to follow-up. The average follow-up time was approximately 6 months, and the response rate for each assessment was > 95%. A total of 90% of patients at baseline met the full clinical criteria recommended for the treatment. Patient adherence to the risk management programme was > 87%. Using the Lotronex risk management programme, patients met clinical criteria, were knowledgeable about treatment risks and benefits, and were adherent to the process elements of the programme. These patients seemed to engage in active dialogue with their physicians about symptoms and use of alosetron.