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China's drug watchdog and the Ministry of Health (MOH) have suspended the production and sale of methotrexate and cytarabin hydrochloride, two drugs often used to treat acute leukemia and rheumatoid arthritis, made by Shanghai Hualian Pharmaceutical Co., Ltd.
The State Food and Drug Administration (SFDA) and the MOH took the decision after the National Center for Adverse Drug Reaction Monitoring reported that the drugs had caused adverse reactions including difficulty in walking and retention of urine in some leukemia patients. Several children suffering from leukemia in three hospitals of Guangxi Zhuang Autonomous Region and Shanghai felt pain in their legs and some had difficulty in walking after being injected with the methotrexate drug made by the Shanghai company in early July. The SFDA and the MOH said in a notice jointly issued on Wednesday that the decision was made to ensure drug safety for the public and to prevent similar incidents from occurring. The SFDA earlier suspended the sale of the two drugs made by the Shanghai company about a week ago. According to WHO statistics, there have been more than 12,500 reports of adverse reactions to methotrexate world wide.
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