Teva Pharmaceutical Industries Ltd.’s (TEVA) Cephalon unit has recalled one batch of its Treanda cancer drug, after the discovery of glass fragments in a single vial.
Israel-based Teva recalled the batch for potential safety risks. Treanda is administered intravenously, and the presence of particulate matter in such medicines could disrupt blood flow, causing tissue or organ damage, or emboli (blood clots), especially in vulnerable patients such as those undergoing surgery, immunosuppressed individuals, and the elderly, as well as patients with macro or microvascular disease, such as heart or kidney disease, who may be more at risk since their blood vessels and organs are already compromised.
Treanda is approved to treat chronic lymphocytic leukemia and non-Hodgkin’s lymphoma in certain conditions.
The batch of Treanda recalled by Teva was distributed to wholesalers and distributors in the U.S. between March 22nd and October 5th, 2011. The customers who received the affected batch were notified of the recall on November 18, 2011 via overnight notification. “We’ve received no adverse event reports on the lot,” said Teva spokeswoman Denise Bradley.
(The damaged batch is lot TB30111)
As though it isn’t horrible enough to be going through this treatment for leukemia, or non-Hodgkin’s lymphoma, some very unfortunate patients had glass being fed through their veins. Now they have to be fearful that the very treatment that is supposed to be helping them heal is making them sicker. Hopefully, this was corrected and will never happen again.
It’s pretty baffling, not to mention appalling, to find out, either via the company, or word of mouth, or even from this blog post, that something like this could happen today. Shards of GLASS in a vial of medication!!! As I was writing this article, I found myself reading, and then re-reading what I had written, and every time I had chills running down my spine. Disregarding the negligence and irresponsibility of the drug company, I just pictured myself administering this treatment and feeling shards of glass enter my bloodstream. Thankfully, Teva caught their mistake before anyone was injured. But regardless, would you trust a drug company that can’t even instill an effective quality control procedure that could (and SHOULD) catch an error like this, before their product is released into the stream of commerce? Is this justice?
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