ONE OF Ireland’s foremost authorities on obesity has questioned a decision by the European Commission to make a slimming pill available over the counter.
Alli (Orlistat) was licensed as a non-prescription drug by the European Commission last week following a decision by the US Food and Drug Administration (FDA) to also approve it as a non-prescription drug despite concerns that such availability could be open to abuse. It is the first prescription medicine for obesity that has gone on to be available over the counter.
Orlistat, under the trade name Xenical, has been available in a prescription dose of 120mgs for 10 years. The over-the-counter dose will be half that. The drug works by preventing fat absorption.
Dr Donal O’Shea, a consultant endocrinologist and director of the Weight Management Clinic at St Columcille’s Hospital in Loughlinstown, said he would have preferred had the drug not been licensed as an over-the-counter medicine because of the need for detailed medical advice beforehand.
“My concern is that patients will start on it without being aware of the strict diet and lifestyle changes necessary and, if they don’t know that, it either won’t work or they will get side effects,” he said.
However, GlaxoSmithKline (GSK), the manufacturers, said the drug would be available only in pharmacies and each pharmacist would be trained on the advice they need to give to patients who request it.
Alli will be given only to people with a body mass index of more than 28 and not to those under the age of 18.
The drug retails at about $2 (€1.55) a dose in the US, and a similar price is expected here when it is launched in three months. It must be taken three times a day for up to six months.
GSK head of regulatory and external affairs Niall O’Shea said: “People who request it will have to talk to pharmacists and we intend to have a comprehensive training programme for pharmacists so that those who request it have proper information about how the drug works as part of a low-fat diet.”
He said those who cheated using the drug could suffer from nasty side effects, including diarrhoea and flatulence.
Clinical trials have shown that Alli increases weight loss by 50 per cent in clinical trials.
The Irish Medicines Board said it was bound through its membership of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) to license the drug as an over-the-counter medicine.
A statement from the board said the committee was reassured that patients taking Alli 60mg would be encouraged to continue seeing healthcare professionals for weight-related issues, such as blood pressure checks or tests for diabetes.
Consultant psychiatrist Dr Patricia Casey said she believed that drugs such as Alli should be available only on prescription. “I think there is a huge potential for abuse by people who are either over-eating or under-eating,” she said.
However, Dr John Griffin, medical director of the Eating Disorder Programme at St Patrick’s Hospital in Dublin, said he did not anticipate that the drug would be used by anorexics to boost weight loss.
“I think that anybody who has tried these type of pills have found that they don’t work very well.”
