Clipping Board » Drug Poisoning ─ It is necessary to be aware of the toxic side effects before taking medication.
January 23, 2010, China Times [Reported by Zhong Yujie and Zhu Liqun]
The weight-loss drug "Reductil" contains the ingredient "sibutramine," which has been found in European and American studies to increase the risk of heart attacks and strokes. On the 21st, the European Medicines Agency (EMA) under the European Union temporarily revoked Reductil's marketing license.
Taiwan's Food and Drug Administration (TFDA) followed suit yesterday, announcing an immediate ban on doctors prescribing weight-loss drugs containing "sibutramine" for patients with cardiovascular diseases. Including "Reductil," there are nine drug licenses in Taiwan that contain this ingredient. So far, no cases of cardiovascular events caused by "sibutramine" have been reported.
The European Commission will further deliberate on whether to revoke Reductil's sales license. However, Abbott voluntarily halted its sales in Europe on the 22nd.
The EMA also urged doctors and pharmacists to stop prescribing and selling weight-loss drugs containing "sibutramine," including Reductil, Reduxade, and Zelium, stating that the health risks of these drugs outweigh their benefits.
The U.S. Food and Drug Administration (FDA) has required Abbott to include stronger warnings on Reductil's labeling, indicating that it is unsuitable for patients with coronary artery disease, congestive heart failure, hypertension, arrhythmia, or a history of stroke.
A large-scale multinational clinical trial spanning six years found that those taking Reductil had a 16% higher risk of heart attack and stroke compared to those taking a placebo. Among the 10,000 participants, most were over 55 years old and had cardiovascular diseases.
Since its approval in the U.S. in 1997, Reductil has been approved in over 70 countries worldwide, with more than 18 million users. Since 2001, around 17 deaths in the UK have been suspected to be related to Reductil, with six cases involving heart attacks or strokes.
Pharmaceutical companies estimate that 90% of those relying on weight-loss drugs in Taiwan take Reductil. Wang Dejing, manager of Abbott Taiwan, estimated that since its launch in Taiwan in 2002, three million people have used the drug.
Lü Lifu, head of the Drug Safety Evaluation Division at TFDA, stated that the agency has officially requested pharmaceutical companies to upgrade the "warning" for cardiovascular patients to a "contraindication," temporarily banning its use for such patients. The TFDA has also notified major medical associations to prohibit prescribing "sibutramine" to weight-loss patients with cardiovascular diseases.
Zou Meijun, head of the Drug Division at TFDA, stated that the agency recommends doctors thoroughly assess patients' cardiovascular conditions before prescribing. The TFDA is currently gathering international data and will submit it to the Drug Advisory Committee for reevaluation. If experts conclude that the drug indeed increases the risk of stroke and cardiovascular death in weight-loss patients, the TFDA may follow the EU's lead and require drugs containing "sibutramine" to be withdrawn from the Taiwanese market.
Source: http:/ / news. chinatimes. com/ 2……0501+112010012300137,00. html
EU Revokes Approval for Sibutramine
The weight-loss drug "Reductil" contains the ingredient "sibutramine," which has been found in European and American studies to increase the risk of heart attacks and strokes. On the 21st, the European Medicines Agency (EMA) under the European Union temporarily revoked Reductil's marketing license.
Taiwan's Food and Drug Administration (TFDA) followed suit yesterday, announcing an immediate ban on doctors prescribing weight-loss drugs containing "sibutramine" for patients with cardiovascular diseases. Including "Reductil," there are nine drug licenses in Taiwan that contain this ingredient. So far, no cases of cardiovascular events caused by "sibutramine" have been reported.
The European Commission will further deliberate on whether to revoke Reductil's sales license. However, Abbott voluntarily halted its sales in Europe on the 22nd.
The EMA also urged doctors and pharmacists to stop prescribing and selling weight-loss drugs containing "sibutramine," including Reductil, Reduxade, and Zelium, stating that the health risks of these drugs outweigh their benefits.
The U.S. Food and Drug Administration (FDA) has required Abbott to include stronger warnings on Reductil's labeling, indicating that it is unsuitable for patients with coronary artery disease, congestive heart failure, hypertension, arrhythmia, or a history of stroke.
A large-scale multinational clinical trial spanning six years found that those taking Reductil had a 16% higher risk of heart attack and stroke compared to those taking a placebo. Among the 10,000 participants, most were over 55 years old and had cardiovascular diseases.
Since its approval in the U.S. in 1997, Reductil has been approved in over 70 countries worldwide, with more than 18 million users. Since 2001, around 17 deaths in the UK have been suspected to be related to Reductil, with six cases involving heart attacks or strokes.
Pharmaceutical companies estimate that 90% of those relying on weight-loss drugs in Taiwan take Reductil. Wang Dejing, manager of Abbott Taiwan, estimated that since its launch in Taiwan in 2002, three million people have used the drug.
Lü Lifu, head of the Drug Safety Evaluation Division at TFDA, stated that the agency has officially requested pharmaceutical companies to upgrade the "warning" for cardiovascular patients to a "contraindication," temporarily banning its use for such patients. The TFDA has also notified major medical associations to prohibit prescribing "sibutramine" to weight-loss patients with cardiovascular diseases.
Zou Meijun, head of the Drug Division at TFDA, stated that the agency recommends doctors thoroughly assess patients' cardiovascular conditions before prescribing. The TFDA is currently gathering international data and will submit it to the Drug Advisory Committee for reevaluation. If experts conclude that the drug indeed increases the risk of stroke and cardiovascular death in weight-loss patients, the TFDA may follow the EU's lead and require drugs containing "sibutramine" to be withdrawn from the Taiwanese market.
Source: http:/ / news. chinatimes. com/ 2……0501+112010012300137,00. html