RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

The RAPS store will be under maintenance Saturday, 13 June between 6 AM and 12 PM EST. Store functionality may be unavailable at times during this window.
We apologize for any inconvenience caused during this time.

Regulatory Focus™ > News Articles > EMA Warns of Potentially Contaminated Cancer Drug in Light of Manufacturing Deficiencies

EMA Warns of Potentially Contaminated Cancer Drug in Light of Manufacturing Deficiencies

Posted 24 August 2012 | By Alexander Gaffney, RAC 

Regulators at the European Medicines Agency (EMA) have released the results of an assessment undertaken after an inspection of California-based Pacira Pharmaceuticals uncovered good manufacturing practice violations and sterility issues.

The assessment pertains to a single drug, DepoCyte (cytarabine), used to treat patients with lymphomatous meningitis, a rare peripheral cancer affecting the spinal cord and brain tissue.

EMA officials said they had inspected Pacira's San Diego-based DepoCyte facility in July 2012, where they found, "Deficiencies in the manufacturing process of DepoCyte, relating to a lack of adequate sterility assurance."

Though officials said they have not confirmed any instances in which a non-sterile DepoCyte product has reached patients, they said the findings posed a "theoretical risk of sterility failure," and were recommending EU Member States recall the drugs if alternate treatments were available. In countries where no alternative exists, regulators said the drug may still be used, but should have close patient monitoring to ensure no unexpected adverse events occur.

Until EMA regulators have re-inspected the plant, new batches of DepoCyte will not be manufactured or released, EMA said.

Pacira did not have any statement available on its website.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.