Shire Recalls Gaucher Disease Drug Due to Steel Particles

Shire Pharmaceuticals is recalling three lots of Gaucher disease drug Vpriv after finding stainless steel and barium sulfate particles in a small number of vials.

The particulates were discovered in a single batch that was packaged into three lots of Vpriv (velaglucerase alfa), Shire said. A third-party supplier’s fill finish process was the source of the problem, the company added.

Shire said the safety risk to patients is low and that it had not received any adverse event reports or customer complaints associated with the three lots of the drug. However, if a drug containing barium sulfate particles is infused into a patient it could lead to rare, but serious, adverse events, Shire said.

Shire believes that any health risk can be mitigated by the package insert’s “required visual inspection of the reconstituted Vpriv product and by administration of Vpriv through an in-line low protein-binding filter.”

Shire has initiated several CAPAs in response to the problems, and it has established new standard operating procedures for managing reported product deviations, spokesperson Gwen Fisher said March 17. The drugmaker is also setting up a particulate management team to focus on implementing process improvements, she added. Fisher declined to name the supplier that Shire faults for the Vpriv problem.

The drug was approved as a long-term enzyme replacement therapy for pediatric and adult patients with type 1 Gaucher disease.

The recall is the latest involving particulates; the FDA has encouraged industry to focus on the issue of particulates through manufacturing equipment upgrades and establishing stronger supplier audit programs.

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