EU Recalls Cancer Meds Made By Boehringer Unit

EU Recalls Cancer Meds Made By Boehringer Unit

November 28th, 2011 // 1:15 pm @

The manufacturing problems engulfing the troubled Boehringer Ingelheim unit have just grown worse. The European Medicines Agency has just issued a ‘precautionary’ recall for the remaining batches of three cancer meds – Busilvex, Velcade and Vidaza – that were manufactured at its Ben Venue Laborartories facility in Ohio. And no new patients are to be treated with yet another med, Doxil.

The move comes just four days Ben Venue disclosed plans to “voluntarily and temporarily” suspend production and distribution at its Bedford, Ohio, plant, and one month after reluctantly putting a halt to its contract manufacturing activities, exacerbating shortages of various life-saving meds for which alternate sources are not always available (read here).

The EMA took this step following a joint inspection by regulators from the EU and France, as well as the FDA, earlier this month, which obviously precipitated the decision to halt production at the Bedford plant. The inspection “highlighted several shortcomings in the quality-management system,” according to the EMA, which is reviewing “all centrally authorized medicines that are manufactured at the site.”

“The potential risk of batch contamination due to the shortcomings in quality management at the North complex (which is part of the Bedford facility) means that only medicines which are absolutely essential to meet patients’ needs can be used and which are currently not available from another source,” according to the EMA’s Committee for Medicinal Products for Human Use.

The recalls are the latest blow to the Boehringer unit, which publicly blamed capacity constraints for chronic shortages until we reported last June that inspectors from both the EMA and FDA had visited its facilities and cited Ben Venue for various deficiencies that contributed to production slowdowns. At the time, a spokesman insisted the inspections did not cause a change in production capability (see this).

As for doctors and patients, the EMA is concerned about side effects that may result due to treatment with Doxil, which is made by Johnson & Johnson and marketed as Caelyx in Europe. Ben Venue is the only supplier for the drug, and J&J has so far been unable to offer alternatives. For this reason, the EMA opted against a recall; alternate supplies do exist for the other cancer meds.

“The CHMP advised that healthcare professionals should monitor treated patients intensively and immediately notify any relevant safety concerns that could be evidence of a quality assurance problem (particularly any cases of sepsis or suspected sepsis, such as acute pyrexia),” according to the EMA .


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