Abbott Laboratories has announced it will voluntarily withdraw Reductil (sibutramine) from the South African market after discussions with the Medicines Control Council.
It is recommended that patients taking Reductil make an appointment with their doctor at the next convenient time to discuss alternatives for losing weight. Patients who wish to stop treatment before seeing their doctor can do so at any time. Patient and doctors questions can be directed to the following people at Abbott: Dr X Mabaso +27 (0) 11 858 3037 or Ms G Partridge +27 (0) 11 858 2034 until a toll-free number has been set-up.
The Medicines Control Council's recommendation was based on a review of results from the SCOUT study (Sibutramine Cardiovascular OUTcome Trial), which became available in November 2009. The approximately 10 000-patient, six-year SCOUT study was requested by European regulatory authorities as a post-marketing commitment to evaluate cardiovascular safety in high-risk patients. The majority of the patients in the SCOUT study had underlying cardiovascular disease and were ineligible to receive sibutramine under the current labelling and prescribing information.
Reductil (sibutramine) is approved in South Africa for weight loss in patients who are either obese or overweight, have no previous history of cardiovascular disease and have been unable to lose weight through diet and exercise.
About Abbott
Abbott is a global, broad-based health care company committed to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs approximately 90 000 people and markets its products in more than 130 countries.
The company's news releases and other information are available at www.abbott.com.
