Sterilisation fears prompts recall of cancer drugs

Three cancer drugs have been recalled by the European Medicines Agency amid fears of shortcomings in the manufacturing process.

The European Medicines Agency has issued precautionary recalls for Busilvex, Velcade and Vidaza and is also warning that no new patients should be treated with Caelyx.

All four of the drugs are manufactured in the US at the Ben Venue Laboratories, but an inspection of the Ohio-based facility found weaknesses in quality assurances and good manufacturing processes (GMP).

The quality management system relating to the aseptic filling process was identified as the main problem at the lab, particularly in Ben Venue’s North facility.

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Following the inspection, which was carried out by medicine agencies from the UK, France and the US Food and Drug Administration (FDA), Ben Venue agreed to halt the manufacture and distribution of its medicines.

Out of all four of the medicines, Caelyx is the only one solely manufactured by Ben Venue and the European agency recognised that it was essential for patients already taking the drug as part of their treatment.

However, in an attempt to be frugal with the supplies of the drug, they said it was essential it is not prescribed to any new patients.

Meanwhile, to dispel any potential panic or concerns about the recall causing drug shortages, the agency reassured people that the supply would not be affected because there are alternative suppliers manufacturing Busilvex, Velcade and Vidaza.

Ben Venue has pledged to investigate the shortcomings identified during the GMP inspection and the European Medicines Agency has said it will issue updates concerning the recall as and when they occur.

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