2010-11-02 10:57:49　　Source：国家食品药品监督管理局

Office of the State Food and Drug Administration [2010] 432
 
October 30, 2010 release
 
In recent years, the European Union, Australia and other countries and regions to study a cardiovascular adverse events of sibutramine international multi-center clinical study showed that the drug can increase the risk of serious cardiovascular subjects. To protect the safe use of drugs, the State Food and Drug Administration experts on the use of sibutramine in the security of our country has assessed that the use of sibutramine may increase the risk of serious cardiovascular, weight loss is greater than the risk of treatment effectiveness .

According to "Drug Administration Law" and Article 42, "Drug Administration Law Ordinance," Article 41, it was decided to stop sibutramine formulations and bulk drugs in our production, sale and use of, revocation of its approval documents has been marketed drug recall by the manufacturer is responsible for the destruction.

Please food and drug administration departments at all levels immediately notify the relevant drug production within its jurisdiction, operation and use of units, and supervise the implementation of the requirements.

                 


State Food and Drug Administration
October 30, 2010