Pretoria - Abbott Laboratories has agreed to withdraw the drugs Ectiva and Reductil from the South African market.
The medicines, which contain Sibutramine, were registered in 1999 for weight loss and weight loss maintenance in obese patients. Patients with a Body Mass Index of 30kg/m2 or higher were considered obese and as well as those with a Body Mass Index of 27kg/m2 or higher in the presence of hypertension, diabetes and dyslipaedimia.
In a statement by the Medicines Control Council, a post marketing study was recently conducted as part of the registration requirements of the European Medicines Agency (EMA) to look at cardiovascular safety of Sibutramine.
"The results of the SCOUT study have shown that patients using Sibutramine have a higher risk of cardiovascular events such as heart attack, stroke, resuscitated cardiac arrest or death compared with placebo treated patients," said the council.
It said on this basis, the council entered into discussion with Abbott Laboratories on ways to mitigate risks. Abbott has since decided to withdraw the drugs and the council will take appropriate action in this regard.
The use of Sibutramine, which is also available in generic forms, is contraindicated for patients with a presence of, or history of coronary artery disease, congestive heart failure, tachycardia, peripheral arterial occlusive disease, arrhythmia or cerebrovascular disease and uncontrolled hypertension.
"Members of the public including patients taking Sibutramine are advised to consult their doctors for any concerns regarding this matter," said the council.
