New Antiobesity Drug Regulations In UK

29 May 1997

The London, UK-based Royal College of Physicians has publishedguidelines for the management of overweight and obesity with drugs, particularly Servier's Adifax (dexfenfluramine), as this is the only drug currently licensed in the UK for the treatment of obesity beyond 12 weeks. The report was produced in response to growing concerns, voiced by the Medicines Commission, of the possibility that antiobesity drugs are being used inappropriately. The RCP hopes that these recommendations will be taken up by the General Medical Council and become part of Good Clinical Practice.

The RCP recommends that antiobesity drugs may be only be used in the treatment of the very obese (a body mass index of 30kg/m2 or greater), and then only if patients have failed to reduce weight by 10% after three months of supervised diet, exercise and general lifestyle changes. If patients are prescribed antiobesity drugs, they should be carefully monitored and their general practitioner should be notified.

More Long-Term Data Required If no response, defined as a weight loss of 10%, is achieved after a period of 12 weeks, treatment with Adifax should be discontinued, say the guidelines. If a response is noted, then treatment may continue for up to 12 months, but not beyond this time as there are no data on the long-term safety effects of this drug. The RCP calls for more long-term studies to be conducted into the safety and effectiveness of antiobesity drug therapy.

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