BATCHES OF two drugs used to treat bone marrow cancer patients in Ireland have been recalled.
The drugs Busilvex and Velcade 3.5mg, understood to be widely used by bone cancer patients here were recalled by the Irish Medicines Board last week.
The recall comes following a site inspection of a US-manufacturer of the drugs, Ben Venue, that highlighted quality assurance problems in the sterilisation process.
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended the precautionary recall of the cancer drugs on November 22nd following the site inspection.
Recall letters from the Irish Medicines Board (IMB) to Irish hospitals in receipt of the affected batches were issued last week.
The board said replacement stocks of both drugs, manufactured at an alternative site, are available.
The IMB is advising patients taking the drug that the recall is precautionary and that no batch of any of the medicines being recalled has yet been found to be defective.
The IMB has also contacted healthcare professionals about a third drug manufactured at the Ben Venue plant called Caelyx. Used in the treatment of ovarian and other cancers, the board says that patients already receiving this treatment should continue to take it as the benefits still outweigh any potential risk of contamination.
However, as the product is not currently manufactured by any other company, the European Medicines Agency is advising that it not be prescribed to any new patients in order to preserve existing stocks for those currently on the therapy.
Two other products manufactured at the plant and also subject to recall, Velcade 1mg and Vidaza are not currently marketed in Ireland.
