Over the counter for the overweight

The EU Medicines Directive has decided that Orlistat, a weight-loss drug, can go on sale over the counter. You’ll be able to buy it without a prescription from pharmacies, and online. The difference between the over-the-counter version and the prescription variety will be the dose: the usual prescription strength is 120mg three times a day – the OTC product will be 60mg.

Is patient choice and increased availability a good thing? All drugs have side effects, and Orlistat – or Alli as the OTC version is to be called – is no exception. The side effects are mainly to do with bowels and incontinence – I will spare you any more detail. Still, it seems to suit some people, and there is evidence of benefit. How much benefit? The majority of studies on Orlistat have used the 120mg dose. Most trials also involved people being given stringent dietary and exercise advice. In trials, people taking Orlistat – with these provisos in place – have lost about 2kg-5kg more than people taking a placebo.

The problem is that we won’t know if this OTC development will work or not. As far as I can see, no one is looking into whether it will make a measurable and effective difference to people’s weight under these lower-dose and real-world conditions.

The other problem is fragmentation of care. The fact that more people are becoming involved with a patient’s healthcare without shared notes makes me concerned that we are creating problems-in-waiting. Shouldn’t we get this sorted out before even more drugs obtain an OTC licence?

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