Beijing:
China has banned 15 slimming products containing the drug sibutramine by ordering their recall across the country due to concern that the diet pills could lead to an increased risk of heart disease.
The State Food and Drug Administration (SFDA) made an announcement banning the production, sale and use of all anti-obesity medications containing sibutramine, the state-run China Daily reported today.
The ban on sibutramine in China follows the US Food and Drug Administration's decision in early October to remove the drug from the market after tests established that it raised blood pressure and posed a risk to patients' cardiovascular systems.
The European Union, Australia and Canada also pulled products containing the drug earlier this year.
According to data released by the SFDA, from 2004 to 2010 Chinese hospitals received 298 reports on side effects of sibutramine, with symptoms such as cardiopalmus, or palpitations of the heart, constipation, dizziness and insomnia.
China's drug watchdog made the decision based on the latest research on sibutramine, which revealed that the risks of using these medications, including heart disease and strokes, outweighed the potential benefits to obese patients, the official media said.
Sibutramine is a chief ingredient in anti-obesity medication that alters a patient's appetite and metabolism. It was introduced as an anti-obesity medication in the United States in 1997 and received approval from the SFDA in China in 2000.
The SFDA named 15 weight-loss products that contain sibutramine, including Qumei capsules, which account for about half of the diet drugs on the Chinese market, and Aoquqing, another popular choice for consumers.
As a result of the announcement, producers are required to recall and destroy products containing the drug.
Lu Changlin, a cardiologist at the Beijing Tongren Hospital, said sibutramine would not impair a patient's health over a short period, but the drug could harm cardiac muscles and valves if it is taken for over 12 months.
"And the damage is irreversible," he added.
The Taiji Group, which produces Qumei, said its sales revenue exceeded 5 billion yuan ((USD 749.57 million) since the weight-loss product went on sale in 2000.
An official statement by the group said Qumei was voluntarily recalled on Oct 25 and customers can return the product directly to drug stores, or by calling their hotline: 400-887-7698.
The State Food and Drug Administration (SFDA) made an announcement banning the production, sale and use of all anti-obesity medications containing sibutramine, the state-run China Daily reported today.
The ban on sibutramine in China follows the US Food and Drug Administration's decision in early October to remove the drug from the market after tests established that it raised blood pressure and posed a risk to patients' cardiovascular systems.
The European Union, Australia and Canada also pulled products containing the drug earlier this year.
According to data released by the SFDA, from 2004 to 2010 Chinese hospitals received 298 reports on side effects of sibutramine, with symptoms such as cardiopalmus, or palpitations of the heart, constipation, dizziness and insomnia.
China's drug watchdog made the decision based on the latest research on sibutramine, which revealed that the risks of using these medications, including heart disease and strokes, outweighed the potential benefits to obese patients, the official media said.
Sibutramine is a chief ingredient in anti-obesity medication that alters a patient's appetite and metabolism. It was introduced as an anti-obesity medication in the United States in 1997 and received approval from the SFDA in China in 2000.
The SFDA named 15 weight-loss products that contain sibutramine, including Qumei capsules, which account for about half of the diet drugs on the Chinese market, and Aoquqing, another popular choice for consumers.
As a result of the announcement, producers are required to recall and destroy products containing the drug.
Lu Changlin, a cardiologist at the Beijing Tongren Hospital, said sibutramine would not impair a patient's health over a short period, but the drug could harm cardiac muscles and valves if it is taken for over 12 months.
"And the damage is irreversible," he added.
The Taiji Group, which produces Qumei, said its sales revenue exceeded 5 billion yuan ((USD 749.57 million) since the weight-loss product went on sale in 2000.
An official statement by the group said Qumei was voluntarily recalled on Oct 25 and customers can return the product directly to drug stores, or by calling their hotline: 400-887-7698.
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