AnonymousNovember 25, 2011 at 11:06 am
The FDA maintains a current list of blood-product recalls on its site. Look under Biologics and then recalls near the middle of page. http://www.fda.gov/cber/recalls.htm There you will find the IVIg products which have been recalled.
The brand I initially received was recalled and so I was given a different brand the last couple of years …
If starting down this path and nervous about it, Kelly is correct where she states (in a different post) that the manufacturers really stay on top of this. I didn’t miss a beat and have not contracted anything from the massive quantities of IVIG I took prior to my stem cell transplant. However, there are possible complications and if going to the above website, you will see numerous IVIG recalls each year.
All treatments currently available for CIDP come with potential serious side effects. But since there are not many options, I chose to stay as informed as possible!
AnonymousNovember 25, 2011 at 1:38 pm
[FONT=”Microsoft Sans Serif”]Additionally, while IVIG works wonders for some, it should be clearly noted that it does absolutely nothing for others. I was one of the latter.
And with all blood products, there always exists unforeseen risks, albeit rare due to the diligence of how blood products are handled post the onset of HIV. Since HIV was unknown in the 70’s, HIV was not screened by the blood banks since, obviously, they did not know to do so. Hence, folks were getting exposed to it via routine transfusions. The question comes to mind, “what if there is currently an unknown, unidentified virus lurking in human blood that will manifest in 10 or 30 years from now?”
That goes for all blood products– I received 4 bags of red blood in 10 days during my hospitalization for stem cell transplant. I actually had to sign a waver accepting the use of blood transfusions.
So whether it is IVIG, red blood or platelets, there is always a risk.
One example that comes to mind with IVIG is my friend Jim D who has posted here briefly during his SCT. He is the one Sophie and I went to Chicago to help out during his treatment. Jim tested positive for Hepatitis B core antibodies after several (ineffective) treatments of IVIG. Blood tests prior showed he had none. Although these antibodies are considered “dormant,” the doctors did have to administer extra antiviral medications to prevent them from becoming “active,” once his immune system was knocked down by the chemotherapy. It was, and will always be, an extra consideration for him.
Just food for thought and words of caution. [/FONT]
November 25, 2011 at 6:29 pm
Thank you, Linda and Alice for addressing the very fears that have kept me idle in respect to proceeding with IVIG. I must admit, however, that I am more confused and scared out of my mind than ever before. I have a great deal to consider, ponder, and pray upon. Not that I haven’t already.
If CIDP has affected my autonomic nervous system than I know I have to do more for myself than take the natural approach for fear that I will lose my life.
If I wasn’t a mom to a young child there’s no question I would have started the infusion therapy the moment I was diagnosed. But I’m scared out of my wits that I will contract a disease that will take my life sooner and, therefore, leave my daughter without a mother.
All along I’ve been assuring her that CIDP will not kill me. I’ve remained optimistic and repeatedly reminded her that while it’s an inconvenience, I can still do most things I did before; but differently. This is how I’ve approached the disease. I’ve thought all along that it was about pain, which I’ve been able to manage with natural products, and an inconvenience not being as mobile as before. I truly did not believe it could take my life, though. So my reasoning was, why risk even the remotest possibility of being infected with diseases that can come along with IVIG?
I won’t pretend to know anything about stem cell transplants because I don’t. But, wouldn’t I need to have been infused with IVIG before they even consider me for an evaluation? What are the risks that come along with these transplants? Has anyone ever died from one?
While I strongly want to walk on the streets of Paris as we’ve done in the past, my greatest desire is to live for many more decades to be around for my daughter. Can’t I do both???
I guess I need to be evaluated to see if the CIDP has actually compromised my autonomic system, and take it from there.
For all of you out there who have made a decision, regardless of the approach you’ve chosen, your courage to go forward with it is so enlightening and encouraging to me.
My sincerest thanks to you, and to all those who continue to teach me about this mean-spirited disease. I wish you all the best life possible!
AnonymousNovember 26, 2011 at 9:23 am
There are risks associated with each type of treatment that is currently used for CIDP, so I read all I can about any type of treatment.
My doctor chose to start me on IVIG since his research showed him the long term benefits far outweighed possible risks. He also told me the IVIG had the least long term complications. Many have great results from the IVIG – even children. Emily’s success is one that comes to mind! I did initially – felt like my old self, working full time, gardening, out dancing 3-4 nights a week again, etc – but my CIDP became more progressive and the IVIG became less effective.
But that is my story – yours could (and probably will) be much different. I did not seek the stem cell transplant until after I gave other options a chance to work (and that is also the criteria to be accepted into the program – that conventional treatments are not working). The most excellent thing about the IVIG is that, while on it and since it boosts the immune system, I never got sick once! Not even a sniffle. And remember, my brand of IVIG was one that was recalled … but, again and as shown on the recall website, the manufacturers do stay on top of all blood products, and I have no complications from its use. It just quit working for me … so onto the next option.
Life is risk! For many, the various treatment options do place the CIDP into remission. I would think trying nothing would be a bigger risk than doing everything in your power to get it under control. I wish you great success in your pursuit of the right treatment and I pray you will feel His leading – I know I did.
November 26, 2011 at 10:42 am
Thank you, Linda. I sincerely appreciate your sage advice.
The last few days have proven to be overwhelming. I wish so much that it had been my neurologist who had informed me back in May of the necessity to proceed with the IVIG. When my husband asked what those infusions would do for me, all he said was, “They’ll make her stronger.” That was it.
I had never been informed of the possibility of my condition getting worse, or that other systems of the body could be compromised. I was never even told about the related symptoms; nothing. Despite the frustration of that, though, I won’t allow myself to dwell on it. As far as I’m concerned, it would serve no purpose.
I’m ready to move forward as I know now what needs to take place. I’m grateful to Kelly and each of you for having taken the time to open my eyes. Thanks again.
Have a lovely day. But more so, a lovelier life! 🙂
AnonymousNovember 26, 2011 at 10:45 am
I checked out your link. I’m not sure where you see that IVIG products have been recalled. I only went back to 2008 but I only see 1 IVIG product that was recalled in 2010. It was recalled “To inform customers of a recent change in pH specification range.”
There have been Anty-thymocyte globulin recalls – which is rabbit plasma, given to people as an anti-rejection treatment & to people with aplastic anemia.
Perhaps I’m not seeing the correct the info? (Could be my turkey hangover, LOL)
AnonymousNovember 26, 2011 at 11:38 am
So I did more reading…
IVIG was recalled in 2004 2 times, by 2 different manufacturers, due to an increase in adverse reactions (I’m assuming rash, flu like symptoms, etc). Also in 2007 2 brands were recalled. 1 was for increased rash & the 2nd was they found glass particles in undistributed vials during routine inspection.
I didn’t see any recalls due to blood borne infection transmissions.
I was thinking about Jim C & testing positive for Hep B. I’m assuming he and/or the dr’s at Northwestern immediately contacted the manufacturers of the IVIG he was taking? I would think a full investigation would have been done by the manufacturer. I would also think Jim C may have grounds to contact a lawyer if it can be proven he tested positive from the IVIG. I know I would….just on the principle that a person shouldn’t get sick from the medicine they are taking.
I find this stuff very fascinating…I’m off to read more recalls. Interestingly, I saw quite a few immunization recalls. Which I think I need to investigate further.
AnonymousNovember 26, 2011 at 12:03 pm
Apparently I’m easily distracted today or something. I did find recalls of IVIG in 2011 & 2010.
Gammaguard was recalled in 2011 as a precautionary measure. The company that makes the glass vials found metallic particles in embedded in the glass. Octagam was recalled also due to increased risk of thromboembolic events.
But I’m still not finding any disease transmissions…which puts my mind at ease.
AnonymousNovember 26, 2011 at 12:23 pm
[FONT=”Microsoft Sans Serif”]It was Jim D who contracted the core antibodies of Hep B. And he received IVIG from a few different locations, two in california and one in Illinois (at least)– so nailing down where it may have come from would be an impossibility.
When first diagnosed, he did not test positive for these antibodies– and was told that it is not uncommon to contract something like this because it could have come from one of the thousands/millions that donate — perhaps who once had or had been exposed to a particular virus. Although not considered a tragedy as they are dormant, they were a mild concern when neutropenia was introduced. Hence the extra usage of antiviral medications as preventative.
There was another person at the same time at NW, undergoing SCT, that also tested positive for these antibodies.
In both cases, infectious disease doctors were brought on board to monitor throughout the protocol.
Claudia, please don’t be too put off by these small and few risks. IVIG helps many, many people and you may be one of them. The discussion here is to inform on all aspects.[/FONT]
AnonymousNovember 26, 2011 at 12:51 pm
SORRY! Jim C.
I told you …I have turkey hangover, LOL. I’m just not with it today. Perhaps it’s from the lack of sleep last night. Emily has a cold, which makes her cough…a lot & I’m dogsitting my mom’s dog and he likes to bark at every.single.noise he hears. Which means when my cat is roaming the house at 3am the dog is barking.
Anyway…enough of my complaining, LOL.
There is a way to track down what IVIG’s a person gets. Every single vial of IVIG has a label that includes batch & lot #’s. Any institution giving IVIG should remove those labels & the info should be recorded into the patients medical file. (And if you are like me, you request the labels for yourself to keep in your binder)
All it would take is to get copies of his medical records from any place he received IVIG to find out exactly what batches of IVIG he received.
I would think it would be medically ethical for the dr’s at Northwestern to have this info & to pass it onto the IVIG manufacturers so they can 1) Contact any patients who have received those same batches & request they be tested, 2) Find out the info on donors for that batch & test them all for Hepatitis & 3) Refine their cleaning process.
Since I’ve had experience with Baxter, when Emily had her Broviac infection, I know they would want this info.
I also did some research on Hep B because I didn’t know much about it. If anyone is interested check out these links:
Kelly (thinking of napping)
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