Australia's drug regulator has rejected claims made over the weekend that it had called for obesity drug sibutramine to no longer be prescribed.
Reports in News Ltd publications alleged that doctors were ordered to stop prescribing sibutramine, marketed in Australia as Ectiva or Reductil, after a clinical trial found it could be potentially fatal.
In a statement to Pharmacy News, however, the Therapeutic Goods Administration (TGA) said the allegations were "incorrect".
"A 'Dear Doctor' letter was circulated by Abbott Australasia, the sponsor of sibutramine, on 24 December, 2009 advising doctors of the changes to the sibutramine PI [product information]," the TGA statement said.
"This letter was sent in consultation with the TGA. Prescribing of the product has not been restricted and it has not been withdrawn from the market."
The regulator revealed that it received 192 suspected adverse reactions to sibutramine since March, 2002, and 54 in the past 3.5 years.
The trial referred to in the News Ltd reports was a study, dubbed SCOUT, released in November last year that showed more cardiovascular events were reported in sibutramine patients than those taking a placebo.
According to Abbott, most of the 10,000 people in the SCOUT study would not have been eligible for sibutramine because of an underlying cardiovascular disease.
"The communication to GPs followed preliminary results from the SCOUT study and reinforced already-existing information in the PI stating that Reductil is not intended or recommended for use in patients with cardiovascular disease and inadequately controlled hypertension," Abbott spokeswoman Jennifer Stevenson said.
The TGA said it was continuing its safety audit of the drug and would be reviewed at the inaugural meeting of the Advisory Committee on the Safety of Medicines, which replaced the Adverse Drug Reactions Advisory Committee.