The Health Sciences Authority (HSA) updates its advisory on sibutramine (Reductil®, Abbott), an anti-obesity drug, to include information on the recently completed review by the central European Committee for Proprietary Medicinal Products (CPMP).
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Background
In March 2002, the Italian regulatory authority temporarily suspended the sale of sibutramine due to the occurrences of adverse drug reactions including 2 reports of death in Italy suspected to be associated with sibutramine. The Italian authority also initiated a request to the CPMP to reassess the efficacy and safety of sibutramine.
Pending CPMP's outcome of the review, HSA reviewed the safety data of sibutramine in March 2002 and concluded that the risk benefit profile of sibutramine remains positive and it would not be necessary to take similar regulatory action to suspend the marketing approval of the drug.
Pending CPMP's outcome of the review, HSA reviewed the safety data of sibutramine in March 2002 and concluded that the risk benefit profile of sibutramine remains positive and it would not be necessary to take similar regulatory action to suspend the marketing approval of the drug.
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Completion of CPMP's review
The CPMP has recently finalised its view on sibutramine in June 2002. The Committee considers that the risk-benefit profile of sibutramine remains positive. The CPMP will continue to keep the product under regular review. The opinion of the CPMP was supported by analysis of data that included clinical studies of sibutramine, dating back to 1989 in about 12,000 obese patients.
To-date, none of the other regulatory agencies including the Medicines Control Agency, UK, the Food & Drug Administration, USA and the Therapeutics Goods Administration, Australia has taken any regulatory actions against the marketing authorisation of the drug.
To-date, none of the other regulatory agencies including the Medicines Control Agency, UK, the Food & Drug Administration, USA and the Therapeutics Goods Administration, Australia has taken any regulatory actions against the marketing authorisation of the drug.
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HSA's advisory to healthcare professionals
Physicians are reminded that Reductil® should only be prescribed to patients who have a body mass index (BMI) equal or greater than 30 kg/m2 or patients with BMI equal or greater than 27 kg/m2 with obesity related risk factors such as type II diabetes and dyslipidaemia who have not responded adequately to an appropriately designed weight reduction programme. Treatment must also be discontinued if a 5% weight reduction is not achieved within 3 months. In addition, Reductil® should only be administered as a component of a therapeutic approach to weight loss on the long-term, under the supervision of a physician experienced in obesity treatment. The drug has been approved for treatment of obesity for up to 1 year only.
Reductil® can cause elevations of blood pressure and heart rate in some patients. Hence it is necessary to monitor the blood pressure and pulse rate regularly, especially during the initiation of therapy. The drug should be discontinued if blood pressure levels exceed 145/90 mmHg at 2 consecutive readings. Reductil® is contraindicated in patients with inadequately controlled hypertension and in patients with history of heart diseases such as congestive heart failure and irregular heart rhythms. Detailed information regarding the use of Reductil® can be found in the product information leaflet.
All healthcare professionals are encouraged to report any adverse drug reactions suspected to be associated to Reductil® to the Pharmacovigilance Unit.
Reductil® can cause elevations of blood pressure and heart rate in some patients. Hence it is necessary to monitor the blood pressure and pulse rate regularly, especially during the initiation of therapy. The drug should be discontinued if blood pressure levels exceed 145/90 mmHg at 2 consecutive readings. Reductil® is contraindicated in patients with inadequately controlled hypertension and in patients with history of heart diseases such as congestive heart failure and irregular heart rhythms. Detailed information regarding the use of Reductil® can be found in the product information leaflet.
All healthcare professionals are encouraged to report any adverse drug reactions suspected to be associated to Reductil® to the Pharmacovigilance Unit.
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