|Date:||22 November 2011|
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The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended a recall of three drugs used in cancer therapy following an inspection of a US manufacturing site that highlighted several quality assurance problems in the sterilisation process.
Two of the drugs, Busilvex and Velcade (used for the treatment of bone marrow cancer), manufactured by Ben Venue in the United States, are available in the United Kingdom and some batches are being recalled as a precaution due to a theoretical risk of contamination. Alternative manufacturers of these products are supplying the EU and UK market and shortages are not anticipated. Patients should continue their treatment.
Vidaza, used to treat some forms of leukaemia, is also being recalled although affected batches of this product are not available in the UK.
A fourth drug, Caelyx, an antitumour agent used to treat breast cancer, is also manufactured by Ben Venue but is not currently manufactured by any other company. Therefore to preserve existing stocks for those currently on this therapy, the product is not to be prescribed to any new patients. However those already on this treatment will continue to receive it because the benefits still outweigh the risk.
If patients have any questions they should talk to their GP or healthcare professional.
At the moment, the affected batch numbers of the UK stock is unknown. The MHRA is liaising with manufacturers to identify the affected batches and Drug Alerts will be issued tomorrow once this information has been supplied.
Notes to Editor
- The joint inspection was carried out by the Medicines and Healthcare products Regulatory Agency (MHRA) and the French regulator AFFSAPS during 7-11 November 2011.
- Further information can be found on the EMA’s website:
EMA press release: European Medicines Agency gives interim recommendations to deal with shortcomings in quality assurance at Ben Venue Laboratories (external link)
- The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks. We keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem. We encourage everyone – the public and healthcare professionals as well as the industry – to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action. www.mhra.gov.uk