Obesity Drug Reductil (Sibutramine) has licence suspended
Anti-obesity drug sibutramine (Reductil) has had its licence suspended and GPs are being asked not to issue any new prescriptions for the drug. The suspension follows a review of the drug’s safety by the European Medicines Agency (EMEA) on the basis of data from the Sibutramine Cardiovascular Outcomes study.
This follows the suspension of the marketing authorisation for Accomplia (Rimonabant) in October 2008. The EMEA decided that the benefits of Acomplia, no longer outweighed its risks.
This leaves Orilstat (Xenical) which acts by reducing the body’s ability to absorb fats as the only major drug left in the GP’s armoury when attempting to manage obesity through conservative (non-surgical) means, although many patients find some of the side-effects of this drug unpleasant and/or embarrassing.
The review which brought about the suspension of Reductil concluded there was an increased risk of non-fatal heart attacks and strokes with sibutramine. The EMEA said that this risk outweighed the benefits of weight loss, which was modest and may not have been sustained in the long term after stopping treatment.
Prescribers are being advised by the MHRA not to issue any new prescriptions for sibutramine and to review the treatment of patients taking the drug. Pharmacists are asked to cease dispensing the medicine.
People who are currently taking sibutramine are advised to make a routine appointment with their doctor to discuss alternative measures to lose weight
Last year, 86,000 people were prescribed sibutramine on the NHS. The drug was licensed for as adjunctive therapy within a weight management programme. Its indication was limited to patients with either nutritional obesity and a BMI of at least 30 or nutritional excess weight and a BMI of at least 27 in those with obesity-related risk factors.
Surgical intervention for weight loss is, or should be, only considered for patients with a BMI of at least 40, or a BMI of at least 35 if they have other weight-related severe medical problems. For patients whose obesity is still a significant problem, but who do not qualify for surgery, the Intragastric Balloon is a procedure worth considering. It is designed to remain in the body for 6 months and enable the patient to lose (on average) between 10 and 30 KG, though careful management and long term dietary change must be part of the programme.
For further information on the Balloon and on Surgical solutions to Morbid Obesity please visit http://www.cosmeticbliss.co.uk/p/weight-loss-surgery
