Abbott’s weight-loss drug suspended in Europe
pharmafile | January 25, 2010 | News story | Sales and Marketing | Abbott, Reductil
Doctors have been told not to prescribe Abbott’s weight-loss treatment sibutramine after a safety review found evidence of serious cardiovascular side effects.
Marketed in Europe under a number of brand names, including Reductil, Reduxade and Zelium, European regulators have recommended its marketing authorisation should be suspended.
A six-year trial of more than 10,000 patients found the drug was associated increased risks of serious, non-fatal cardiovascular events such as stroke or heart risk.
Sibutramine is used to promote weight-loss in obese patients and in overweight patients who also have other risk factors sych as type II diabetes or dyslipidaemia (high levels of fat in the blood).
A safety review based on the Sibutramine Cardiovascular Outcome Trial (SCOUT) by the Committee for Medicinal Products for Human Use (CHMP) concluded that the risks of these medicines are greater than their benefits.
It found patients treated with sibutramine experienced a 16% increased risk of cardiovascular events such as myocardial infarction (heart attack) and stroke compared with placebo-treated patients.
The study also showed that the average weight loss achieved with sibutramine was modest, with sibutramine decreasing body weight by 3.5 kg compared with 1.6 kg on diet and exercise alone over the course of the study.
The CHMP noted that the use of sibutramine was not in accordance with the prescribing information for most of the patients enrolled in the SCOUT study, as sibutramine is contra-indicated in patients with known cardiovascular disease. Moreover, the treatment duration in the study was also longer than normally recommended.
However, because obese and overweight patients are likely to have a higher risk of cardiovascular events, the Committee said the SCOUT data was relevant for the assessing use of the medicine in clinical practice.
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