EMA recalls cancer drugs manufactured by Ben Venue
Inspection revealed problems in aseptic filling process at Ohio plant in the US
Four cancer drugs and the antiviral medicine Vistide have been recalled owing to problems in the sterilisation process at Ben Venue Laboratories, a US contract manufacturer.
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recalled bone marrow cancer drugs Busilvex and Velcade, which are produced by Ben Venue in Ohio, as a precaution.
Alternative manufacturers of these products are supplying the EU and UK market and shortages are not anticipated, said EMA.
The drugs regulator has also recalled Vidaza, used to treat some forms of leukaemia.
Breast cancer drug Caelyx, which is also manufactured by Ben Venue, will not be prescribed to preserve stocks.
A joint GMP inspection of the site, by the UK and French medicines regulatory agencies together with the US FDA on 7–11 November highlighted several shortcomings in the quality management system, particularly in relation to the aseptic filling process in the North Complex of the Ben Venue facility.
During the inspection, Ben Venue decided to cease all manufacture and distribution of medicines from its site, which has been the object of increased GMP surveillance, and to investigate the GMP issues identified.
The affected batch numbers of the UK stock is as yet unknown. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is liaising with manufacturers to identify the affected batches and drug alerts will be issued shortly.
