The Department of Health (DOH) said yesterday that pharmaceutical companies selling slimming pills containing sibutramine are required to submit a risk assessment and control plan within one month so that the DOH can decide whether to ban the products from the local market.
Despite reports that weight-loss drugs containing sibutramine might increase the risk of cardiovascular disease, a committee on drug safety under the DOH did not reach an agreement on Thursday on withdrawing such products from the local market.
Tai Hsueh-yung (戴雪詠), section chief of drug safety assessment under the Food and Drug Administration, said nearly 75 percent of people who take sibutramine are not considered obese because they have a body mass index (BMI) value of less than 30.
“What concerns us is that healthy and slim people are taking these drugs, which might increase their cardiovascular disease risk,” Tai said.
Sales of the drug have been suspended in the EU, while the US Food and Drug Administration has not reached a consensus on withdrawing the drugs.
In Taiwan, 14 drugs containing sibutramine have received regulatory approval, including Reductil, Sytramee, Losfat, Moi-Allison, Sibutil, Shapedesign and Controkilo.
According to health authorities, the drugs should only be taken by obese people with a BMI value higher than 30, or those with a BMI higher than 27 who also have a history of type 2 diabetes or hyperlipidemia.
The DOH might also class the drugs as prescription only, Tai said.
Tai said the Taiwan Medical Association for the Study of Obesity has argued that removing sibutramine from the market would only limit the already sparse selection of weight-loss medications, which would make businesses more likely to illegally promote their weight-loss products and exaggerate their therapeutic effects.
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