Voluntary Limited VELCADE Recall

This is from the Millennium Pharmaceuticals web site. Just a snippet here, with the URL so you can read more. Chances are good you’ve already heard about this if you’re on Velcade.

As a precautionary measure, Millennium is voluntarily recalling a limited number of lots of VELCADEĀ® (bortezomib) for Injection 3.5mg/vial due to the possibility that small white polyester particles may be observed upon reconstitution of VELCADE drug product.

Millennium is undertaking this recall in consideration of the potential for safety issues if the affected product is administered to patients including local injection site reactions, inflammatory responses and thromboembolic events.

The VELCADE Package Insert (Section 2.7) and Investigator Brochure have specific guidelines recommending visual inspection for particulate matter or discoloration prior to administration. Do not use the reconstituted product if you observe particulate matter or discoloration.

The U.S. Food and Drug Administration (FDA) has been informed of this voluntary limited recall.

This action is limited to the VELCADE lots listed below, produced by one of our manufacturers before certain process improvements were implemented.

http://www.mlnm.com/velcade_recall.asp

I was in a trial once, and got a letter about there being some particles found in my drug, too. I wonder how polyester and other things get into our drugs?

2 Comments

  1. pat allen

    My husband received several cycles of Velcade from July thru September, 2010. His last cycle was cut short by his oncologist due to increasing symoptoms of neuropathy. A neurologist diagnosed severe neuropathy which has not eased in the eight months following his last Velcade dose. Could this be one affect of the contaminated vials?

    • Beth

      I don’t think the contamination caused any more side effects. I’m not really sure. You could contact Millennium about it.

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