UK. An update on suspected adverse drug reactions reported in association with sibutramine (Reductil) is presented in the September 2003 issue of the bulletin: Current Problems in Pharmacovigilance. Since sibutramine was licensed in Europe in May 2001, approximately 130 000 patients in the UK have been prescribed the agent. The most commonly reported adverse reactions include headache, hypertension, tachycardia, palpitations, chest pain, dizziness, insomnia, depression, anxiety and minor gastrointestinal symptoms. Prescribers are reminded of the recommended protocol blood pressure (BP) and heart rate (HR) monitoring in patients receiving sibutramine, and that treatment should be discontinued in patients who have a persistent increase in resting HR of ≥ 10 beats/min or BP of ≥ 10mm Hg.
Reference: Current Problems in Pharmacovigilance, September 2003. Available from URL: http://www.mca.gov.uk