Regulatory Focus™ > News Articles > French Regulators Issue Warning About Celgene's Abraxane

French Regulators Issue Warning About Celgene's Abraxane

Posted 23 January 2014 | By

French regulators on Wednesday issued a warning regarding Celgene's pancreatic cancer drug Abraxane (paclitaxel), saying that "fine protein filaments" had been observed in some drug units.

The warning, issued by the French regulatory authority Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), said that the 1-2 mm-long white and yellow filaments had been observed during visual inspections of the drug, but were not thought to be dangerous.

"On the basis of currently available data, there is no increased risk of embolic events if these filaments are inadvertently administered to patients," ANSM wrote, according to a translated version of the notice.

The filaments were reportedly caused by a reaction between albumin, a component of Abraxane, and silicone oil.

ANSM recommended that if any filaments are observed to be present in IV bags of Abraxane, the drug should be administered through a filter no more than 15 microns thick or discarded.


Editor's note: A spokeswoman from Celgene contacted Focus to clarify that the formation of the filaments did not occur as a result of the product coming into contact with silicone oil during the drug's manufacture. We regret the implication.

 

ANSM Statement (22 January 2014)


Tags: France, EU

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