China warns against cancer-fighting medication
Updated: 2011-12-09 05:18
BEIJING - China's State Food and Drug Administration (SFDA) on Thursday warned of safety risks related to the use of the AIDS-related cancer-fighting medication Caelyx and Velcade, drugs used for treating myeloma and lymphoma.
The warning came after European Medicines Agency gave interim recommendations to deal with shortcomings in the quality of the two medications produced at Ben Venue Laboratories.
The agency launched a precautionary recall for the remaining batches of Velcade and stopped new patients from being treated with Caelyx after an inspection found several shortcomings in relation to the aseptic filling process.
The inspection was launched by medicine regulatory bodies from Britain, France and the United States from Nov 7 to 11 this year at the Ben Venue facility.
The SFDA has ordered the Xi'an-Janssen Pharmaceutical Ltd, the import agent of the two products, to recall all Caelyx on the market and to stop selling Velcade.
The SFDA is requiring the company to inform doctors and patients of the potential risks and advise patients to replace Caelyx with alternatives.