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Safety-issue drugs sold in China
By Ding Yining |
July 10, 2012, Tuesday
|
Print Edition
Print Edition
FOUR drugs made by Swiss drug maker Roche that are under investigation by the European Medicines Agency for safety issues are currently sold in China.
The agency, a body of the European Union, said in a June 21 statement that it is looking into the deficiencies in the medicine-safety reporting system of Roche.
The Daily Mail has reported that eight drugs were involved, including Herceptin, Avastin, Tarceva and Pegasys, all of them available to Chinese patients, among which three are for cancer patients and one for treating hepatitis B, according to Roche China's official website.
Four others include drugs such as Actemra and Rituxan.
Roche China said it is looking into the matter together with its overseas headquarters and is trying to find out if there is any adverse effect reports in China related to these medicines, an official with the company told Shanghai Daily yesterday.
The non-assessment and non-reporting of these adverse events was not intentional, Roche said in a statement, according to the Daily Mail report.
The investigation was triggered by a routine inspection by the UK medicines watchdog that found Roche failing to disclose some 15,161 deaths of patients as well as more than 65,000 cases of suspected side effects reported by patients in the US.
The agency, a body of the European Union, said in a June 21 statement that it is looking into the deficiencies in the medicine-safety reporting system of Roche.
The Daily Mail has reported that eight drugs were involved, including Herceptin, Avastin, Tarceva and Pegasys, all of them available to Chinese patients, among which three are for cancer patients and one for treating hepatitis B, according to Roche China's official website.
Four others include drugs such as Actemra and Rituxan.
Roche China said it is looking into the matter together with its overseas headquarters and is trying to find out if there is any adverse effect reports in China related to these medicines, an official with the company told Shanghai Daily yesterday.
The non-assessment and non-reporting of these adverse events was not intentional, Roche said in a statement, according to the Daily Mail report.
The investigation was triggered by a routine inspection by the UK medicines watchdog that found Roche failing to disclose some 15,161 deaths of patients as well as more than 65,000 cases of suspected side effects reported by patients in the US.
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