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September 11, 2010

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Home » Metro » Health and Science

FDA joins probe into eye medicine

Shanghai's food and drug administration is cooperating with health authorities to investigate the use of Avastin at local hospitals after 61 patients suffered adverse reactions to Avastin injections for macular degeneration and other eye disorders.

Avastin, produced by pharmaceutical giant Roche, is only approved by China's State Food and Drug Administration as a treatment for colon cancer.

It is not approved to treat eye diseases by domestic authorities.

The Ministry of Health is also investigating in conjunction with the state FDA.

Avastin, which was approved by the United States Food and Drug Administration in 2004, blocks the growth of new blood vessels in cancer and other diseases.

The medicine, approved by many countries for cancer treatment, entered the Chinese mainland market this year.

Though it is not officially approved for the treatment of macular degeneration, hospitals in many countries have used it on patients and consider it an effective treatment which is cheaper than officially approved medicine, according to insiders.

Li Weiping, deputy director of the Shanghai Health Bureau, said yesterday that the bureau is still investigating the cause of the eye infection which sickened dozens of patients at the Shanghai No. 1 People's Hospital.

By yesterday morning, 61 patients were in hospital after adverse reactions from receiving Avastin injections.

A total of 116 patients received Avastin injections on Monday and Wednesday at the hospital.

All the 61 patients with adverse reactions like red eyes and poor vision were among the 116 patients receiving Avastin by two batches, Li said.

Fifty-six patients had undergone treatment by last night, while another five were under observation, he said. No one had lost their sight.

Li said 17 patients with serious infections had undergone eye surgery, while the rest received injections to treat internal eye infections.

All patients were in stable condition and the 56 patients undergoing treatment were recovering. "Some patients will be discharged soon," he said.

One patient told reporters that her left eye was injected with Avastin on Wednesday. She received another injection to deal with the infection but, although the pain had gone, her vision was still impaired.


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