This is not good news for thyroid cancer patients who rely on the drug Thyrogen (thyrotropin alfa). The Food and Drug Administration (FDA) has announced that they have found small particles of steel, rubber and fiber -- trash basically -- in vials of their drugs, including the thyroid drug Thyrogen. They also reported that this contamination could cause serious health effects for patients.This is the second time just this year that Genzyme has been cited by the FDA for contamination of their products. In June of this year, Genzyme had to shut down a key production facility due to viral contamination. (Read FDA press release in PDF format, and Genzyme release.)
In addition to Thyrogen, other Genzyme drugs affected by the current contamination issue include Cerezyme, Fabrazyme, Myozyme, and Aldurazyme.
The FDA is not removing the products from the market, because they say that there are few alternatives to these drugs. The FDA is recommending, however, that practitioners take the following actions:
- Discuss with patients and families the potential for foreign particle contamination and development of adverse events, taking into account the clinical necessity of these products, and the risks associated with untreated illness.
- Visually inspect the powder in the vial for the presence of particles, before reconstitution.
- Visually inspect the reconstituted powder (in solution) and the Aldurazyme solution for the presence of particles.
- Do not use any product with visualized particles. Return contaminated products to Genzyme Corporation (1-800-745-4447, option 2).
- Monitor for local or systemic allergic reactions after administration.
- Consider the clinical utility of levothyroxine withdrawal, an effective and well-established alternative to Thyrogen, versus the potential safety risks from administration of Thyrogen that may contain foreign particles.
- MedWatch 2009 Safety summary, including a link to the Information for Healthcare Professionals sheet
- FDA Notification, November 13, 2009
- Read the Genzyme "Dear Healthcare Practitioner" Letter (PDF format)
Image: clipart.com
The FDA has found trash particles in vials of drugs made by Genzyme but they are worried about safety & efficacy of dessicated thyroid???
I saw the original article on this. It blew me away that the reason they had not worried about it before was that so far, nobody had reported any problems. Um, what?
As the other poster stated, and they are worried about our natural thyroid? PULEASE!
Response to Dorothy,
I was about to raise the same question.as you did.
You sound like the Dorothy that provided the administrators of the FDA who created the downfall to Armour Thyroid. That information was most useful to me.
The direction the Federal Government is taking that is effecting our health is frightening, first Armour and now the Mammograms and this is just the beginning!
The government doesn’t need death panels. They just need to keep messing around with the guidelines (mammograms) and not notifying regarding trash in medicine. This is all an excuse to not have to pay for any testing, drugs, etc. after we pay for mandatory health insurance. Anyone else see a conspiracy brewing, or is it just me?
Lets see…1) visually inspect your vial for ‘trash’ that doesn’t belong there. 1a. Depending on your eye sight, you may or may not see this garbage. 1b. What about the things that are too small too see but STILL are IN the drug?
WHY isn’t the FDA concerned about WHY did this happen? Is this drug made in CHINA? Maybe this is how they are dealing with their garbage problem. Grind it up and put it in to your drugs. Not too long ago there was a recall of the drug Heparin from China because of contamination. Never mind though because the FDA thinks we’re a bunch of idiots.
Nooo…what you are to do is 1) inject this drug/garbage into your body and then 2)WATCH for adverse reactions. LOL LOL LOL…ARE THEY CRAZY????? Ridiculous!!!!!!!!!!!!!!!!!! How about they inject it into THEIR bodies and see if there are any adverse reactions? Don’t use this product people. Find an alternative.
Are you aware that the people making the decision about Mammograms are not all doctors? Three were Private Insurance Company representatives. Conspiracy? Maybe they believe health care will pass and don’t want to pay for any more tests than they have to.
I’m scared to death now…I’m supposed to get my first Thyrogen shot in February before having my body scan done…..and I just can’t think of not having it due to the awful cessation of thryoid meds during the six week pre-interval before the scan. Who wants to deal with being hypothyroid? It’s hell! So…what are we thyroid cancer people supposed to do? Is there anywhere else where they make this stuff besides the ones who are cited?
Helen,
If you switch to synthetic T3 only you can stop it in 2 days for the test, then go back on it immediately. Levothyroxin, Synthroid are T4 storage hormone meds. T3 is the active hormone. Its a little bit tricker to dose, needs to be taken 2-4 times per day but worth it. Talk about it to your doctor.
I was supposed to receive these shots last month, my insurance was questioning the 1200 dollar cost, at the time I was ticked…but now I am thankful.
I think that although going “HYPO” and stopping my synthroid will be exhausting, it sounds more natural than injecting “microscopic debris and garbage” in my body. No wonder nobody trusts big medical companies anymore. Who in their right mind would just “eyeball” a vial for debris? What if its smaller? My gosh, once again Thyroid cancer patients take a back seat. I hope all of you recover and remain strong. This is such a bigger battle than the medical community lets the world know. I had to go to an online group to find support and find answers because this field is such a hit or miss type of mentality. What does it take to make sure your medications are clean and sterile? Who makes these types of mistakes? This is exactly why we should always question when big Medicine companies tell us we NEED to vaccinate our kids with strains of things we have no idea about. Many vaccines are harvested from monkey kidneys and other animals. No wonder viruses and diseases are jumping from animal form to Human strains. QUESTION EVERYTHING and protect your kids from unecessary vaccines.
Just a Mom with three kids and thyroid cancer…
I agree this is terrible news, but it is VERY misleading to state that trash was found. The contaminates were found from the manufacturing process, not from some garbage that floated up on the beach, as your photo suggests.
Going overboard like this only gives credibility to drug companies that state their objectors are out to get them. Please just report the facts if you’re going to warn people and don’t sensationalize this important information. Thanks!
So hasn’t this company heard of quality control? I’m disgusted and will not be receiving Thyrogen again!
Why is no other DRUG Company creating thyrogen with clean
quality control? Give it up Genzyme. People try calling this company- listen the scripted response… Creative writing at cancer patients expense. NBC should pick this up!