REDUCTIL'S makers "respectfully" disagree with the European Medicines Agency's (EMA) recommended suspension of its product. They insist that Reductil is safe if used according to the product label.
Abbott, in an email to the New Straits Times yesterday, said its ongoing evaluation of the Sibutramine Cardiovascular Outcome Trial (Scout) data does not change its assessment that sibutramine has a positive benefit/risk profile when used appropriately in the approved patient population.
"The company believes there are many patients who benefit from sibutramine and respectfully disagrees with the committee's recommendation to suspend the medicine," communications and government affairs director Pamela Harrison said.
She said the Scout was requested by European regulatory authorities as a post-marketing commitment to evaluate cardiovascular safety in patients at high risk for cardiovascular problems.
"More than 90 per cent of patients in the Scout study were ineligible to receive sibutramine under current labelling and none were managed according to labelling guidance -- which recommends the medication be used for one to two years (vs. treatment for up to six years in Scout and requires patients to stop therapy if they do not respond to treatment (vs. continuing on sibutramine without experiencing adequate weight loss, as was done in Scout)."
She said sibutramine remains available outside the European Union and should be used according to the product label.
"The US Food and Drug Administration's (FDA) review of Scout is ongoing. FDA has initiated a label change and the product remains on the market in the United States," she said, adding that Australia's Therapeutic Goods Administration (TGA) took a similar action.
"Sibutramine remains available and should be used according to the product label in Malaysia.
"Sibutramine is approved for the treatment of patients who are obese, have no previous history of cardiovascular disease and have been unable to lose weight through diet and exercise," Harrison said.
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