Sterilisation fears prompts recall of cancer drugs

By Admin
Three cancer drugs have been recalled by the European Medicines Agency amid fears of shortcomings in the manufacturing process. The European Medicines...

Three cancer drugs have been recalled by the European Medicines Agency amid fears of shortcomings in the manufacturing process.

The European Medicines Agency has issued precautionary recalls for Busilvex, Velcade and Vidaza and is also warning that no new patients should be treated with Caelyx.

All four of the drugs are manufactured in the US at the Ben Venue Laboratories, but an inspection of the Ohio-based facility found weaknesses in quality assurances and good manufacturing processes (GMP).

The quality management system relating to the aseptic filling process was identified as the main problem at the lab, particularly in Ben Venue’s North facility.

To read the latest edition of Healthcare Global, click here

Following the inspection, which was carried out by medicine agencies from the UK, France and the US Food and Drug Administration (FDA), Ben Venue agreed to halt the manufacture and distribution of its medicines.

Out of all four of the medicines, Caelyx is the only one solely manufactured by Ben Venue and the European agency recognised that it was essential for patients already taking the drug as part of their treatment.

However, in an attempt to be frugal with the supplies of the drug, they said it was essential it is not prescribed to any new patients.

Meanwhile, to dispel any potential panic or concerns about the recall causing drug shortages, the agency reassured people that the supply would not be affected because there are alternative suppliers manufacturing Busilvex, Velcade and Vidaza.

Ben Venue has pledged to investigate the shortcomings identified during the GMP inspection and the European Medicines Agency has said it will issue updates concerning the recall as and when they occur.

Our magazine is now available on the iPad. Click here to download it.

Share

Featured Articles

Philips Future Health Index Report: AI to Cut Waiting Times

Healthcare technology leader Philips says virtual care and AI is turning in an effort to cope with demand in its Future Health Index Report 2024

HCLTech and Olympus Advance AI into the Healthcare Industry

Giants HCLTech and Olympus Corporation, have developed their partnership to utilise technology and AI to transform the healthcare industry.

Cancer Vaccines Breakthrough a Glimpse of Healthcare Future

As the UK's NHS becomes the first healthcare provider to launch a cancer vaccine testing programme, we explore this groundbreaking oncological treatment

Change Healthcare Cyberattack Fallout Continues

Health Insurance & Finance

McKinsey: National E-health Initiatives on the Rise

Technology & AI

Edwards Lifesciences: a Profile of the Heart Tech Specialist

Medical Devices & Pharma