23 Jan 2010

Weight-loss drug reviewed by safety authority

5:48 pm on 23 January 2010

The Medical Association says doctors and patients should review their use of the popular weight loss drug Reductil following new research linking it with heart problems.

Sibutramine, which is marketed as Reductil, has been pulled off the market in Europe, after a study found an increased risk of heart problems.

The Health Ministry is reviewing Reductil, and reminding doctors it should not be prescribed to people with heart disease.

However, the company which makes sibutramine insists the medicine is safe if taken as intended.

Medical Association chairperson Dr Peter Foley says he has always been concerned about patients seeing the drug as a quick fix.

He says every drug has risks and benefits and any patients who are worried about Reductil should ask to be reassessed by their GP.

Dr Foley says increasing use of direct-to-consumer advertising of drugs like Reductil has led to patients putting pressure on doctors to prescribe them.

Research on Reductil

The European Medicines Agency removed Reductil from sale following its six-year study of 10,000 patients, which concluded that the risk of the medication is greater than its benefits. The United States Food and Drug Administration has put additional restrictions on the use of the drug.

The Government's medicines safety authority, Medsafe, is waiting to see the European findings and seeking information on adverse reactions in New Zealand.

In the mean time, Medsafe is reinforcing its warning that people with a history of heart disease or strokes should not be taking Reductil.

Medsafe's director, Dr Stewart Jessamine, says it has sent out information to doctors reiterating the warning and reminding them that Reductil is a short-term treatment only.

"If doctors follow the rules when they prescribe it, really the risk to patients is minimal," he says. "The problem is assessing what actually happens in the real world."

Safe if used according to guidelines - manufacturer

Reductil's maker, Abbott Pharmaceuticals, says the drug is approved for use by patients who are obese but have no pre-existing heart problems, and its benefits outweigh the risks when it is used appropriately.

The company says 90% of patients who took part in the European study were already at high risk of heart disease and strokes, and would have been ineligible under current labelling.

None were managed according to the guidelines, it says, which recommend patients don't take the medicine for more than a year.