Six adverse reactions to new obesity drug reported to IMB

THE IRISH Medicines Board (IMB) said it has received six reports of adverse reactions associated with the anti-obesity drug alli launched here in April.

The board said it was aware of a review of the drug by the Food and Drugs Administration (FDA) in the United States.

The FDA has received 32 reports of serious liver damage, six of which resulted in organ failure.

The IMB said the complaints it received were for gastro-intestinal disorders, which were “consistent with the type of effects known to occur”. It said it had no reports of a liver-related adverse reaction.

Alli, otherwise known as Orlistat, is an over-the-counter drug which works by absorbing fat, as part of a weight-loss diet and can cause adverse reactions if taken without changes to diet or lifestyle.

Its manufacturer, GlaxoSmithKline, estimates that about 50,000 people are already using alli in Ireland since its introduction.

The drug has been available in Ireland as a prescription-only medicine called Xenical since 1998, but at twice the dose available to those who buy it over the counter.

In a statement, the IMB said it had received 50 adverse reaction reports relating to Xenical (at that higher dose), with problems of gastrointestinal disorders, vomiting, diarrhoea and flatulence.

A small number of liver-related problems was reported in patients who were taking other drugs that could affect their livers.

Alli was introduced with much fanfare to the Irish market and was endorsed by several health experts, including Prof Patrick Wall from UCD’s School of Public Health and Population Science and Dr Martin Henman from the School of Pharmacy and Pharmaceutical Science at TCD.

It also attracted its critics, with Dr Donal O’Shea, a consultant endocrinologist and director of the Weight Management Clinic at St Columcille’s Hospital in Loughlinstown, stating 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.

GlaxoSmithKline Ireland’s head of regulatory and external affairs, Niall O’Shea, said the six adverse reactions reported were actually fewer than had been expected, given the number of people taking the drug.

“We were upfront from the beginning about this. We have been saying to people that if they do not adhere to a low-fat diet while taking this drug there is the possibility of problems like diarrhoea and wind,” he said.

“It has been our experience that because we have been giving information to people, and the pharmacists have been very good in that regard, most people have been adhering to low-fat diets.

“From a positive point of view, people who maintain a low-fat diet and a fat intake of less than 15 grams per meal, will be far less likely to experience any side effects,” he said.