Two drugs used to treat bone marrow cancer are being recalled over a theoretical risk of blood poisoning, a government agency said today.
Some batches of Busilvex and Velcade will be recalled in what the Medicines and Healthcare Products Regulatory Agency (MHRA) described as a “precautionary measure”.
Eight batches of Velcade and nine batches of Busilvex will be returned by hospitals, pharmacies and wholesalers.
The drugs are made in the US by Ben Venue and their recall follows an inspection of a US manufacturing site by the MHRA and French regulator Affsaps earlier this month.
An MHRA spokesman said the inspection had highlighted “several quality assurance problems in the sterilisation process” that presented a “theoretical risk” of sepsis - infection of the blood.
He added: “At this moment in time, we have no evidence to suggest that any patient taking the medicines had any adverse reactions.
“It’s a precautionary measure at the moment.”
Caelyx, an anti-tumour agent used to treat breast cancer, is also manufactured by Ben Venue but patients who are already being treated with it will continue to receive the chemotherapy drug.
The MHRA said the drug is not manufactured by any other firm so will not be prescribed to new patients to preserve stocks but will continue to be prescribed to existing patients as “the benefits still outweigh any potential risks”.
Patients are urged to speak to their GP if they have any questions.
The affected batch numbers and their expiry dates are:
- Velcade: 9AZSY00 (December 2011), 9CZTF00 (February 2012), AGZSH00 (June 2013), AGZSH01 (June 2013), AIZTY00 (August 2013), AIZTY01 (August 2013), BAZS100 (December 2013), BAZS101 (December 2013).
- Busilvex: 055597B (March 2013), 025212B_1 (August 2012), 013019B (May 2012), 013019B_3 (May 2012), 852753B_A (February 2012), 852752B (February 2012), 852752B_1 (February 2012), 797783B_2 (December 2011), 797783B (December 2011).