Reaction by Arseus on distribution of heparin
Arseus hereby responds to media reports regarding the recall by its subsidiary Fagron of a quantity (‘charge’) of contaminated heparin it supplied to eight Dutch hospitals.
Yesterday Fagron announced that the heparin had not been administered to patients. This announcement was based on the available information that the eight hospitals had provided to the Netherlands Health Care Inspectorate (IGZ) and Fagron. On the basis of this information Fagron issued a press release.
Yesterday evening however, the Atrium Medisch Centrum Parkstad in Heerlen reported that, contrary to what it had reported to IGZ earlier, a further quality control inspection had revealed the possibility that around 50 of its patients have been administered the medicine in question.
Fagron emphasises that it properly conducted all legally required test procedures for the charge of heparin, before supplying it to the hospitals. These requirements for the quality controls of heparin are defined in the European Pharmacopoeia. Fagron executed the recall procedure of contaminated heparin in time.
Fagron took all possible actions to trace the potential contamination in the heparin after it became known that patients in the US and Germany, who had been administered heparin, suffered (severe) allergic reactions. Commonly, patients’ allergic reactions occur within 48 hours after intravenous administration.
Arseus regards the safety of patients as its highest priority and the company always fully complies with all applicable pharmaceutical quality procedures. The management of Arseus is convinced there will be no negative financial consequences as a result of this incident.
For further information about Arseus and Fagron, please contact Ger van Jeveren, CEO of Arseus, tel. +31 (0) 88 3311200.