Australia's drug regulator will review new evidence that links a prescription obesity drug to increases in cardiovascular events, following similar moves in the United States and Europe.
The US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) are analysing preliminary results of a recent study which found that patients taking sibutramine, marketed in Australia as Ectiva or Reductil, suffered a higher rate of heart attacks, strokes, resuscitated cardiac arrests and deaths.
Data from the study of 10,000 overweight people older than 55 years, dubbed SCOUT, showed that cardiovascular events were reported in 11.4 per cent of sibutramine patients, compared to 10 per cent of patients using a placebo.
"This difference is higher than expected, suggesting that sibutramine is associated with an increased cardiovascular risk in the study population," the FDA said in a statement.
According to the Therapeutic Goods Administration (TGA), sibutramine product information warns that the drug should not be used by patients with "a history of cardiovascular disease, congestive cardiac failure, tachycardia, peripheral arterial occlusive disease, arrythmia or cerebrovascular disease (stroke or TIA) or inadequately controlled hypertension".
"Also, the Precautions [section] states that blood pressure and pulse rate should be regularly monitored in all patients using sibutramine due to blood pressure increases in some patients," a TGA statement said.