Weight-loss drug Orlistat to go over-the-counter
By Lilian Anekwe
A lower-dose version of the weight-loss drug orlistat is set to become available over the counter after a decision by European medicines regulators.
The Committee for Medicinal Products for Human Use (CHMP), part of the European Medicines Agency, has approved the sale of orlistat as a non-prescription product.
The drug will now be proposed for final approval by the European Commission, and marketing authorisation - allowing manufacturer GSK to market orlistat for sale OTC - could be granted within a few months.
The 60mg dose of the product – half the dosage available in the UK under prescription – will be licensed for adults with a BMI of 28 kg/m2 or more.
The CHMP said it had concluded the switch to OTC could be recommended as orlistat 60mg was effective in helping patients lose weight when taken in conjunction with dieting, its side-effects were milder than the 120mg dose and the product information would guide patients to use it correctly.
Dr Ian Campbell, a GP in Nottingham and former chair of the National Obesity Forum, said: ‘There's enough evidence to show orlistat is safe for people to buy OTC, with some guidance from pharmacists, and the results are almost as good as the 120mg dose.
‘But the patient's motivation to lose weight is what makes the difference – without information about lifestyle changes it won't work. It would be a shame if people think they can just pop a pill and lose weight.'
GSK said clinical trials had shown orlistat 60mg, in conjunction with dieting, could help people lose 50% more weight than dieting alone. It has been available without prescription in the US sine June 2007.
Dr David Haslam, a GP in Watton-at-Stone, Hertfordshire and clinical director of the NOF, said he welcomed the move with 'some provisos'.
'It's the first time a weight loss drug that really works will be made available OTC, and in the context of pharmacists doing more primary care work, it's to be expected. It's giving GPs a helping hand in managing obesity because it's a big problem.
'But my reservations are that I would want to be reassured that the care they receive, particularly if they have other conditions like diabetes that often occur with obesity, that the level of care they receive would be the same that I would provide. I don't want for patientswith underlying health conditions to be missed because they are on these drugs.'Obesity drug orlistat to go over-the-counter