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Diabetes drug to be monitored
By Cai Wenjun and Ding Yining |
September 27, 2010, Monday
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Print Edition
Print Edition
SHANGHAI officials are to closely monitor adverse reactions to an anti-diabetes drug following concerns over the risk of heart disease.
The use of Avandia has been significantly restricted in the United States and sales in Europe are being suspended.
Shanghai's Food and Drug Administration said it would be cooperating with local health authorities to watch out for any problems in the city.
It asks GlaxoSmithKline, the drug's producer, to collect and report on any cases of adverse reactions in the city.
The US FDA restricts the use of Avandia to patients who can't control their diabetes with any other medicine or to current users who are benefiting from the drug.
Last Thursday, the European Medicines Agency recommended suspension of marketing authorization for Avandia and another two GlaxoSmithKline anti-diabetes drugs - Avandamet and Avaglim - with the same ingredient, rosiglitazone. These medicines will stop being available in Europe within the next few months, the agency said.
Dr Jia Weiping, director of the Shanghai Diabetes Institute, said the moves had aroused the concern of the State Food and Drug Administration, which will meet today to discuss the drug's use and adverse reaction supervision across the country.
"Local patients shouldn't panic about the news of Avandia, since its dosage for Chinese patients is much lower than that for US and European patients," Jia said. "In the West, the drug is prescribed by general physicians while the drug in China is used by specialists after careful consideration of the patient's medical history and is not used for patients with cardiovascular problems."
She said Avandia was a popular diabetes drug in China and there had been no reports of serious side effects so far.
GlaxoSmithKline said it had stopped marketing Avandia in all countries including China after regulators withdrew the product in Europe and restricted its use in the US. The British drug maker had notified China's FDA of the latest situation. It will also release a notice to patients.
"We have not received any adverse reaction reports from Chinese patients yet and we suggest patients do not stop taking the medicine before seeking advice from doctors," said a GlaxoSmithKline official.
The use of Avandia has been significantly restricted in the United States and sales in Europe are being suspended.
Shanghai's Food and Drug Administration said it would be cooperating with local health authorities to watch out for any problems in the city.
It asks GlaxoSmithKline, the drug's producer, to collect and report on any cases of adverse reactions in the city.
The US FDA restricts the use of Avandia to patients who can't control their diabetes with any other medicine or to current users who are benefiting from the drug.
Last Thursday, the European Medicines Agency recommended suspension of marketing authorization for Avandia and another two GlaxoSmithKline anti-diabetes drugs - Avandamet and Avaglim - with the same ingredient, rosiglitazone. These medicines will stop being available in Europe within the next few months, the agency said.
Dr Jia Weiping, director of the Shanghai Diabetes Institute, said the moves had aroused the concern of the State Food and Drug Administration, which will meet today to discuss the drug's use and adverse reaction supervision across the country.
"Local patients shouldn't panic about the news of Avandia, since its dosage for Chinese patients is much lower than that for US and European patients," Jia said. "In the West, the drug is prescribed by general physicians while the drug in China is used by specialists after careful consideration of the patient's medical history and is not used for patients with cardiovascular problems."
She said Avandia was a popular diabetes drug in China and there had been no reports of serious side effects so far.
GlaxoSmithKline said it had stopped marketing Avandia in all countries including China after regulators withdrew the product in Europe and restricted its use in the US. The British drug maker had notified China's FDA of the latest situation. It will also release a notice to patients.
"We have not received any adverse reaction reports from Chinese patients yet and we suggest patients do not stop taking the medicine before seeking advice from doctors," said a GlaxoSmithKline official.
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