A POPULAR weight loss drug has been withdrawn from sale following a review by Australia’s medical watchdog and research showing it could cause overweight people to suffer a heart attack or stroke.
Pharmaceutical company Abbott today announced it would immediately cease distribution of its drug sibutramine, which is sold under the brand name Reductil.
Australians now using the prescription-only medicine should make an appointment with their doctor to seek advice on an alternative, a company spokesperson said in a statement. “Abbott today announces that it has voluntarily ceased marketing and distribution of sibutramine in Australia,” the spokesperson said.
The European Medicines Agency suspended the marketing of sibutramine earlier this year, while Australia’s Therapeutic Goods Administration (TGA) moved in June to tighten the conditions under which doctors could prescribe the drug. This followed the release of preliminary results of the six-year and 10,000 patient SCOUT study, which showed the weight loss drug carried a potentially fatal cardiovascular risk.
“Analysis of the final results of the SCOUT study have since confirmed there is an increased … risk of major cardiac events such as heart attack and stroke in obese and overweight patients,” the TGA said in an update posted on its website on Friday. “… It remains unclear whether the safety of sibutramine is acceptable even in those who respond to the medicine.”
The Abbott spokesperson said the company still believed the drug had a “positive benefit/risk profile when used appropriately” although it would be pulled from sale following talks with the TGA. Other known side-effects of the drug include trouble sleeping, constipation, a dry mouth, fast heartbeat, elevated blood pressure, heart palpitations, headache, anxiety and dizziness.