Quality fears prompt cancer drug recalls

pharmafile | November 25, 2011 | News story | Manufacturing and Production |  Ben Venue, EU, Hong Kong, manufacturing 

Regulatory authorities around the world are recalling cancer drugs manufactured by Boehringer Ingelheim’s Ben Venue Laboratories subsidiary after an inspection uncovered quality problems at its manufacturing facility in Ohio, USA.

Inspectors from the European Medicines Agency, the FDA and the UK and French national regulatory authorities carried out a joint inspection at the plant earlier this month and found “several shortcomings in the quality management system”, according to an EMA notice.

The problems centred on the aseptic filling process in the facility, according to the EMA, which said it concerned most about products made their which did not include a terminal sterilisation process.

Ben Venue elected to close down the facility and cease distribution of medicines made there during the inspection.

The EMA ordered a precautionary recall this week for batches of Pierre Fabre’s Busilvex (busulfan), Millennium Pharmaceuticals’ Velcade (bortezomib) and Celgene’s Vidaza (azacitidine), all of which were manufactured at Ben Venue.  

The Hong Kong regulatory authority has since followed suit, issuing a recall for notice for Vidaza and quality alerts for Busulfex (the local trade name for Busilvex), Velcade and Bristol-Myers Squibb’s BiCNU (carmustine).

An investigation by the EMA’s Committee for Medicinal Products for Human Use (CHMP) concluded that “the potential risk of batch contamination due to the shortcomings in quality management at the North complex means that only medicines which are absolutely essential to meet patients’ needs can be used and which are currently not available from another source.”

Alternative supplies are available for all three recalled drugs, said the agency.

A fourth product made in the Ohio plant – Janssen Cilag’s Caelyx (liposomal doxorubicin) – escaped a recall because Ben Venue is the only manufacturing source, although the EMA said no new patients should be treated with the drug until the quality problems are resolved. Hong Kong has also issued a quality alert for Caelyx.

Phil Taylor