Order to remove products with sibutramine off the shelves

The Drug Control Authority has issued orders to remove health products containing sibutramine from the market, as it was found to increase the risk of adverse cardiovascular effects such as heart attack and stroke.

Health director-general Tan Sri Dr Mohd Ismail Merican, in a statement, said the decision to recall and suspend the regisration of products containing the substance was based on a Sibutramine Cardiovascular Outcomes study conducted by Abbot Laboratories on the product, Reductil.

"The study revealed that sibutramine could increase the risk of adverse cardiovascular effects on obese and overweight patients, compared to those who have enough exercise and watch their diet," he said.

Registration holders are ordered to stop all sales of products containing sibutramine and take these products out of the market within 30 days.

Sibutramine is registered in Malaysia as an additional therapy to diet and exercise for obese patients who risk diabetes, hypertension and dyslipidemia, but its consumption is prohibited for those with a history in coronary artery disease, congestive heart failure, peripheral artery disease, heart arrhythmia, stroke and uncontrollable hypertension.

Some of the products found to contain Sibutramine are Reductil, Slenfig, Sibutramine Sandoz, Fenslim and Sibutrim.