Rubber And Steel Fragments Found Inside Medication

The FDA has sent a warning to biotech company Genzyme after particles of rubber, steel, and fibers were found in vials of five of their injectable medications. The contamination occurred during the manufacturing process, and the FDA is concerned because doctors could be, y’know, injecting garbage fragments into their patients.

The affected medications are for patients with relatively rare enzyme disorders.

Genzyme sent letters to healthcare providers reminding them that product labels advise visual inspection of the drug vials and filtration of Cerezyme, Fabrazyme, Myozyme and Aldurazyme to detect foreign particles.

Genzyme notified the FDA about the contaminated drugs through required product quality reports.

Potential health affects from injections of the contaminated products include pain, swelling and inflammation, the FDA said. Potential reactions from intravenous infusions of the affected products could be more serious, including damaged blood vessels, embolisms and allergic reactions.

The same plant that produced these contaminated products was briefly shut down earlier this year after products were contaminated with a virus. That incident raised questions about the company’s processes—this one will surely raise more.

FDA warns Genzyme [Boston Herald]
Genzyme virus exposes vulnerable plant processes [Reuters] (Thanks, Kyle!)

(Photo: kate at yr own risk)

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  1. CaptZ says:

    I can only same one thing about how rubber, steel, and fibers can get into a line of medications……WTF?

    • RickRussellTX says:

      I’m guessing that a belt shredded in their facility and dropped garbage into liquid medication, and the floor workers were afraid to report it.

      If a worker reports a safety or quality problem and is rewarded, then you get better products. If they report a safety or quality problem and get castigated, you get workers afraid to report anything.

      • u1itn0w2day says:

        @RickRussellTX: That sounds the most plausible to me .

        My only question if this is a liquid wouldn’t all mixing and filling of viles be through a seal or cover of somekind ?

        They wouldn’t let liquid filled viles or bottles roll on a belt open top would they ?

        I’m wondering if a belt got damaged which in turn threw a needle or injector off which itself was in turn damaged. You’d figure if one part of the process screws up wouldn’t the entire process shut down til an alarm of somekind was checked ? Would it take ALOT of grinding to get the debris small enough to fit in a vile,iv tube or needle ? -But I guess that goes back to ‘ keep your mouth shut ‘.

      • hills says:

        @RickRussellTX: I think it’s more of an underlying issue – not a one time thing like a shredded belt – these meds are produced at different times (like, weeks/months…), so for the problem to be in 1% of each one of their medicines means there’s an explanation across the board and not a single occurrence.

  2. hills says:

    I know this looks bad, but Genzyme really is a good company – I get enzyme replacement therapy with one of the drugs mentioned above, and they have provided it free of charge for a couple years now… The good news is that the IVs have filters, and no one has reported any side effects. I really hope Genzyme can get it together – they are the only option for a lot of people with rare diseases that other companies have no interest in treating.

    • TheObserver says:

      @hillsrovey: From one of the articles my understanding is that doctors usually use a 0.22 micron filter anyhow when administering this drug- supposedly enough to filter out these contaminants in question. Not sure if a filter is supposed to be used or is recommended.

  3. Paladin_11 says:

    So… where were these drugs produced? If they were produced domestically the FDA has no excuse for not shutting them down immediately pending a thorough investigation. Curious that they have not done so…

  4. premek says:

    Who informed who? the beginning of the article (also the title of Boston Herald article) says that FDA warned Genzyme, but later in both articles it is said that Genzyme warned FDA after testing … I’d say the Boston Herald title is wrong and it should be “FDA warned ABOUT Genzyme…”

  5. Laura Northrup says:

    @hillsrovey: Yeah, title’s been changed. I had an amusing mental picture of the Springfield Tire Fire when I wrote it but the word isn’t accurate.

  6. twophrasebark says:

    “The FDA has sent a warning to biotech company Genzyme after particles of rubber, steel, and fibers were found in vials of five of their injectable medications.”

    Yeah but it was their now with rubber, steel and fiber formulation.

  7. Shoelace says:

    This sounds like it involves a problem with the vials and/or the procedure used to put medication in the vials, but where would fibers (of what?) come from?

    • soloudinhere says:

      @Shoelace: Potentially from the clean room attire of the persons involved in manufacturing. While tyvek is mostly particle-free, that’s not guaranteed, and while the operators are very careful, minute amounts can get in there.

      I gather that Genzyme already knows this about their manufacturing process since these drugs include statements to use filters while administering the drug, so it must be something legitimate in the way they’re manufactured that could potentially introduce inert foreign material.

  8. chrisdag says:

    Genzyme is a good company and nothing about their manufacturing process seems out of the ordinary or unusual for domestic biotech pharmaceutical production.

    As much as some competitors may be gloating right now (I have a friend who works for a company that makes an alternative to one of the popular Genzyme drugs and their sales are expected to skyrocket …) I bet there are many biotech/pharma production people right now trying to find out if something similar is possible in their own facilities.

  9. GadgetsAlwaysFit says:

    Let me understand better here. Based on this comment:
    “Genzyme sent letters to healthcare providers reminding them that product labels advise visual inspection of the drug vials and filtration of Cerezyme, Fabrazyme, Myozyme and Aldurazyme to detect foreign particles.”
    So they are trying to pass the blame to the physicians for not visually inspecting the vials for BITS OF TRASH FLOATING IN THEM!!!! Oh yeah, that absolves them of any responsibility here. If you have been told there could be garbage, which is what debris is, in the meds I cannot believe that no one picked up the phone and called the FDA at that exact moment. Wouldn’t that qualify as some sort of red flag?!?

    • soloudinhere says:

      @GadgetsAlwaysFit: Since the label advises filtration, I imagine that there is something in the manufacturing process that is known to potentially introduce inert material. Might be the only way to make these valuable drugs. If it’s injected via the recommended .22 filter, there is no way any of those particles will even make it out of the syringe.

  10. katia802 says:

    At least they came out in public with it instead of taking the stroller company tact. Let’s wait till 12-15 people are injured then admit to it. Not condoning the sale of contaminated meds, but at least the company is putting out some kind of warning.