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EMA recalls cancer drugs made by Boehringer Ingelheim unit

24.11.2011

London – The European Medicines Agency has recalled all batches of the cancer drugs Busilvex, Velcade and Vidaza manufactured at Boehringer Ingelheim’s Ben Venue Laboratories facility in Bedford, Ohio, from the European market. Following a site inspection earlier this month, the agency, together with inspectors from France and the FDA, identified shortcomings with aseptic filling that are still under review.“The potential risk of batch contamination due to the shortcomings in quality management means that only medicines can be used which are absolutely essential to meet patients’ needs and which are currently not available from another source,” said a spokesman of the EMA’s CHMP. For Caelyx, for which Ben Venue is the only manufacturing source, the CHMP considered the product to be essential only for patients already on treatment. The Committee recommended that supplies should be available to maintain these patients on Caelyx but no new patients should be started on treatment with Caelyx until further notice. However, the EMA noted that, to date, there have been no complaints or reports of adverse reactions that would indicate a lack of quality assurance.

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