China Revokes Licenses For Shanghai Hualian Leukemia Drugs Found Contaminated (China)
This article was originally published in PharmAsia News
Executive Summary
China revoked the license of Shanghai Hualian Pharmaceutical in the wake of an investigation that found it was marketing contaminated leukemia drugs that harmed patients. The company's license was canceled and the employees responsible have been detained, according to the State FDA. The agency accused the employees of a "systematically organized" cover-up during the government investigation of a case of several children injected with methotrexate who developed leg pains and difficulty walking. Use of the drug and another based on cytarabin hydrochloride were ordered suspended in September. The parent company, Shanghai Pharmaceutical Group, was ordered to compensate the families of the patients. (Click here for more ) "Cancer Drug Company Slammed After Probe" Shanghai Daily (China) (12/13/07)
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China revoked the license of
Shanghai Hualian Pharmaceutical in the wake of an investigation
that found it was marketing contaminated leukemia drugs that harmed
patients. The company's license was canceled and the employees
responsible have been detained, according to the State FDA. The
agency accused the employees of a "systematically organized"
cover-up during the government investigation of a case of several
children injected with methotrexate who developed leg pains and
difficulty walking. Use of the drug and another based on cytarabin
hydrochloride were ordered suspended in September. The parent
company, Shanghai Pharmaceutical Group, was ordered to compensate
the families of the patients. (Click
here for more ) |