The European Medicines Agency suspended the licence of Reductil, used by obese patients to aid weight loss.
The move comes after Australia’s regulator proposed extra precautions to doctors in updated product information about Reductil circulated last month by manufacturer Abbott Laboratories, as reported by The Sunday Telegraph last week.
The letter warned sibutramine, marketed as Reductil, must not be prescribed to patients with a history of cardiovascular disease and/or inadequately controlled hypertension.
It also warned the drug should be discontinued in patients who don’t respond adequately within three months or who experience elevations in blood pressure.
The TGA said last week the product was not restricted or being withdrawn in Australia.
But yesterday a TGA spokeswoman said it was aware of the European decision and its review of the safety of the drug was ongoing A spokeswoman said: “The TGA is currently examining the EMA recommendation to determine if further regulatory action is warranted.”
Safety concerns were raised after the Sibutramine Cardiovascular OUTcome Trial or SCOUT study released late last year that found an increased risk of heart attack. Doctors said they were concerned about the drug and the study’s findings because many obese patients had undiagnosed cardiovascular disease.
GP and Australian Medical Association federal vice-president Dr Steve Hambleton said doctors expected the TGA to look at the drug urgently and advise whether practitioners should continue to prescribe it.
He said: “If the overseas agencies have taken this step then the AMA would be keen for Australia to have a very close look at this product to see which group of people it can be safely used in, and if that’s none then we should hear about it as quickly as possible.
“I would be much more anxious and unlikely to start anybody on it until I had further advice from the experts.”
Reductil’s manufacturer, Abbott, said discussions with the TGA about the product’s safety were continuing.
Royal Australian College of GPs president Dr Chris Mitchell added: “[Being] overweight is clearly a risk factor for heart disease so there may well be a large number of people with undiagnosed heart disease who are in the risk groups and may be on those medications.
“GPs need to be quite vigilant about that … I would urge caution.”
Since Reductil became available in Australia, the TGA has received almost 200 reports of adverse reactions and it has been linked to the death of a 19-year-old.
And if Reductil is subject to a ban, the only other weight loss drugs to be sold here would be Duromine – which doctors prescribe reluctantly – and the over-the-counter medication Xenical.