About 17,000 people have taken Reductil in New Zealand. Photo / Herald on Sunday
The weight-loss drug Reductil should be withdrawn from the New Zealand market, a ministerial committee has recommended.
The Medicines Adverse Reactions Committee (MARC), says consent to distribute sibutramine, known in New Zealand under the brand Reductil, should be revoked due to its health risks.
"We have concluded that the risks
of using sibutramine outweigh any benefit from the very modest weight loss observed when using the medicine," Medsafe's principal clinical advisor Dr Enver Yousuf said.
Medsafe and MARC reviewed sibutramine after preliminary results of a major study, the Sibutramine Cardiovascular Outcomes trial or SCOUT, of 10,000 patients found the drug raised the risk of heart attacks and strokes.
New Zealand medical professionals had already been advised against the use of sibutramine in patients with a history of heart conditions or stroke even before the study's results were released, Mr Yousuf said.
Dr Yousuf advised doctors not to issue any new prescriptions for the drug.
People taking Reductil should see their doctor if they had any concerns and seek advice on alternative weight-loss methods, he added.
Phamaceutical company Abbott had voluntarily decided to withdraw sibutramine effective from today.
In a statement Abbott said results of the SCOUT study did not change its view that sibutramine had a "positive benefit/risk profile when used appropriately in the approved patient population".
It said the majority of the patients in the study had underlying cardiovascular disease and were ineligible to receive sibutramine.
Sibutramine has also recently been withdrawn from sale in Australia, Canada and the United States, and the European Medicines Agency suspended sale of the drug earlier this year.
- NZPA
