A joint inspection by UK, French and US regulators two weeks ago found shortcomings in the quality-management system related to the aseptic filling process at the Ohio plant. The European Medicines Agency (EMA) has responded by recalling three oncology drugs and restricting use of a fourth.
“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”, the EMA wrote.
In deciding to recall Busilvex (busulfan), Velcade (bortezomib) and Vidaza (azacitidine) the EMA took supply issues into consideration. Alternative suppliers are available for all three drugs and as such the EMA thinks patients in Europe will continue to receive treatment despite the recall.
Velcade, a multiple myeloma treatment marketed by Millennium Pharmaceuticals and Janssen-Cilag, was among the drugs Health Canada allowed Ben Venue to continue to import despite quality fears. In November 2010 Velcade was recalled by Janssen and Millennium after white particles were found in vials.
Since Health Canada took the action in August scrutiny of Ben Venue has intensified. Ben Venue has now suspended manufacture, a decision the EMA says the CMO (contract manufacturing organisation) made during the November inspection by UK, French and US regulators.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) is talking to manufacturers to identify affected batches. At this time it is unclear which batch numbers are affected. The MHRA is only recalling Busilvex and Velcade as affected batches of Vidaza are not available in the UK.
Doxil dodges recall
A fourth oncology drug, Caelyx (doxorubicin hydrochloride), will only be given to patients already receiving the medication. In the US Caelyx is marketed by Johnson & Johnson (J&J) as Doxil and is in short supply.
Ben Venue is the only supplier of Caelyx and as such the EMA opted against a recall. In September the EMA advised physicians to consider alternatives for patients not already receiving Caelyx. With the shortage predicted to worsen the EMA has reiterated and strengthened this message.
The EMA has told Janssen, which markets Caelyx, to ask healthcare professionals to be extra vigilant and report and suspected adverse reaction or complaints that could be linked to quality failings. The EMA will continue to review the situation.
Remaining supplies of a fifth drug, Gilead’s Vistide (cidofovir), will stay on the market as the EMA thinks the terminal sterilisation process it undergoes lowers risk contamination will harm patients. Alternative manufacturers of Vistide are now supplying Europe.