Last month the EMA (European Medicines Agency) called for the recall of some drugs manufactured by Ben Venue Laboratories. Vistide (cidofovir) was excluded as it undergoes sterilisation, which the EMA said lowers the risk of patient harm, but since then new inspection information has emerged.
“The GMP (good manufacturing practice) inspection has now revealed a possible contamination with particles and the CHMP concluded that the sterilisation at the end of the manufacturing process could not guarantee the absence of particles in the vial”, the EMA said.
Gilead has secured an alternative supplier and as such the precautionary recall of one batch of the antiviral Vistide is expected to have minimal impact on its availability in the European Union (EU).
The EMA is reviewing all drugs produced by CMO (contract manufacturing organisation) Ben Venue at its Ohio, US plant. An initial batch of recommendations was published in November and the EMA has followed this up with further recalls.
Last week the EMA recommended the recall of 14 batches of Ecalta (anidulafungin), an antifungal drug sold by Pfizer. An alternative version of Ecalta, without a diluent, is already available in the EU.
Hong Kong is also recalling Ecalta, sold there as Eraxis, after uncovering new information. Pfizer told the Department of Health Eraxis sold in Hong Kong came from other sources, the regulator said, but the big pharma has since said it imported 2,000 boxes manufactured by Ben Venue in February 2010.
The EMA also called for the recall of a batch of Luminity, an ultrasound contrast agent sold by Bristol-Myers Squibb. Luminity is not essential, the EMA said, so is being recalled as a precautionary action.
A second Pfizer drug, Torisel (temsirolimus), will stay on the market. Ben Venue is the only source of the diluent of the advanced renal cell carcinoma drug and to ensure patients can access the medicine the EMA has opted against a recall.
The same logic has kept Ceplene (histamine dihydrochloride), an acute myeloid leukemia treatment, on the market. Sweden-based Meda sells Ceplene in Europe as part of a licensing deal with EpiCept. Before administrating Ceplene or Torisel physicians should check vials for the presence of particles.
Ben Venue also manufactures drugs for Gilead, Takeda, Alexion Pharmaceuticals, Astellas Pharma and The Medicines Company but no actions will be taken at this time.
“The CHMP does not recommend any precautionary measures since they are either not marketed within the EU, no batch manufactured at the affected Ben Venue facility is currently on the EU market or the medicines undergo filtration prior to administration”, the EMA said.