Fat-buster drug pulled over heart attack fear
Published 22/01/2010 | 05:00
AN ANTI-OBESITY drug taken by 5,000 Irish patients has been suspended after it was found to increase the risk of heart attacks and strokes.
The Irish Medicines Board (IMB) said patients taking a medicine that contains sibutramine and is marketed here as Reductil should cease the treatment. It urged those affected to seek advice from their doctors on other ways to lose weight.
Reductil has been on the market in Ireland for the past nine years.
Joan Gilvarry, the IMB's director of human medicines, said its decision was in line with a recommendation from the European Medicines Agency (EMA).
She said: "Sibutramine is a prescription medicine that is used to assist weight loss in... adult patients or overweight patients with other risk factors, such as type-2 diabetes."
The decision to recommend suspension followed a pan-European review of data, which showed that Reductil caused an increased risk of heart attacks or strokes in patients with cardiovascular disease.
"The risk is also considered to be applicable to patients without a diagnosis of cardiovascular disease as obesity is a risk factor for cardiovascular disease," explained Ms Gilvarry.
"In addition, when all available study data were considered, it was noted that the weight loss achieved with sibutramine treatment was modest in comparison with that obtained with a placebo."
In the interest of patient safety, the recommendation from the EMA was that the marketing authorisation for medicines containing sibutramine should be suspended across the EU.
Ms Gilvarry said such medicines had always been inadvisable for patients who were known to have cardiovascular disease.
However, following a review and assessment of recently available data from the study, which involved 10,000 people, the increased risk was also found to apply even to those with no history of cardiovascular disease.
She added: "We have a relatively small number of patients using these products in Ireland and there are alternative treatments available."