A manufacturer of an obesity drug linked to increased cardiovascular side effects has downplayed the significance of the study that prompted regulators to embark on a safety review.
The Therapeutic Goods Administration confirmed yesterday that it would follow US and European counterparts in reviewing 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.
According to Reductil manufacturer Abbott, most of the patients in the SCOUT study of 10,000 people would not have been eligible for the therapy.
"The clear majority of the SCOUT study – 90 per cent – actually had a history or an underlying cardiovascular disease which is a contraindication for Reductil already," Abbott spokeswoman Jennifer Stevenson told Pharmacy News.
"We don't think the data indicates a change in the safety profile of sibutramine when it used in the approved patient population."
The drug's Australian product information already advises against its use for patients with a history of a number of cardiovascular diseases and warns of possible increases in blood pressure.
"The point of that whole study was to look at the high risk population and it just highlights that the people in that study don't really match the approved labelling for the product anywhere else in the world," Ms Stevenson said.