CONTROVERSIAL fat-busting drug Reductil will continue to be sold in Malaysia -- for now.
The Health Ministry, in a statement yesterday, said the Drug Control Authority (DCA) had received information regarding suspension of products containing Sibutramine (the active ingredient in Reductil) by European medical regulators.
The decision was made based on the results of the Sibutramine Cardiovascular Outcome Trial (Scout), conducted by Reductil's maker Abbott, to evaluate cardiovascular safety in high-risk patients with a history of cardiovascular disease.
The six-year study, which involved 10,000 overweight and obese patients who had a history of heart disease and/or diabetes, indicated that about 11.4 per cent of those who took the drug had a heart attack or stroke compared with about 10 per cent who took a placebo.
In Malaysia, there have been a total of 35 adverse drug reports for Sibutramine to date. Four were related to cardiovascular problems. Three of them were of palpitations and one was of a non-fatal myocardial infarction.
"The DCA will instruct all Sibutramine product registration holders to circulate a 'Dear Health Care Professional' letter to all prescribers in Malaysia regarding this new information as well as adding the description of the Scout study in the product insert, to further strengthen its safety information," the ministry said.
It added that all nine drugs containing Sibutramine sold in Malaysia have warnings for patients with a history of coronary artery disease, congestive heart failure, tachycardia, peripheral arterial occlusive disease, arrhythmia or cerebrovascular disease and inadequately controlled hypertension.
The DCA will continue to monitor the situation and assess any new information regarding Sibutramine for further regulatory action.
The ministry's decision was described as "a sensible move" by National Heart Association vice-president Datuk Dr Azhari Rosman.
He said that though many clinical trials had taken place, they had their limitations.
He added that it "is good practice" to have feedback from many parties before deciding to yank medicines off shelves.
Reductil, according to its maker Abbott, is prescribed to over 15 million patients in 80 countries.
It works as a weight loss drug by blocking nerve cells that release and reabsorb the hormone serotonin, a chemical neurotransmitter in the brain that affects moods and appetite.
As the level of serotonin in the body rises, people feel fuller, eat less and, as a result, lose weight.
The Scout findings set alarm bells ringing in Europe and the United States.
Last Thursday, the European Medicines Agency conducted a safety review of medicines containing sibutramine and concluded that the risks of the medicines outweighed their benefits.
It recommended suspending marketing authorisations for sibutramine and removing drugs with the chemical from all markets in the European Union.
Medicines that contain sibutramine include Reductil, Reduxade and Zelium.
The same day the US Food and Drug Administration requested the manufacturer of the drug to add a new contraindication to the existing warning for the sibutramine drug label. Reductil is sold in the United States as Meridia.
The new warning will indicate that patients who have uncontrolled high blood pressure, heart arrhythmias, peripheral vascular disease, or those who have had a personal history of heart attack or stroke, should not use the drug for weight loss.
Australia's Therapeutic Goods Administration (TGA), on the other hand, confirmed that there would be no restrictions placed on the drug.
The drug has also been widely used in India since 1999. However, the Drug Controller General of India (DCGI) has now decided to take the matter to an expert group.
"If experts see a problem in the drug, the manufacturers would be asked to immediately stop its production," DCGI Surinder Singh told The Indian Express.
http://health.asiaone.com/Health/News/Story/A1Story20100127-194763.html
