More on Recall

A board to discuss the Multiple Sclerosis modifying drug Avonex

More on Recall

Postby september1968 » Fri May 21, 2004 8:58 am

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Postby Xenova » Sun May 23, 2004 3:16 pm

I just looked at my syringe stash and figured out that the last 2 boxes that I finished had been part of the recall. I wonder if this is why I've been feeling like crap lately.

FYI-lot numbers are on the syringes. Here are the recalled lot numbers:

Lot Numbers / Expiration Date:
P30027 June 2005
P30028 June 2005
P30029 June 2005
P30030 June 2005
P30031 June 2005
P30032 June 2005
P30033 July 2005
P30034 July 2005
P30036 July 2005
P30038 July 2005
P30039 August 2005
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They said everything is A-OK

Postby wilson » Sun May 23, 2004 5:44 pm

When ordering my next shipment of Avenox with the delivery company, I asked the customer service rep the status about the current inventory of Avenox. I was told that they had attended a meeting and Biogen stated that everything is all right after all.

Someone is not telling the truth. I just wish I knew who.
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Postby Shayk » Sun May 23, 2004 7:03 pm

Well, September 1968, I appreciate your making us aware of this info.

Unfortunately :( , I disposed of my first sharpie container week before last, so don't even have the syringes to look at. I had saved one "box front" with the script on it from February for medical reimbursement purposes, and sure enough it was from the recall.

I am guessing that out of the 4 1/2 months I've been on Avonex I've probably had 8-12 of the recalled jabs. Very disconcerting to say the least.

Wilson, are your side effects starting to taper off?

Hope everyone is as well as can be.

Sharon
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Postby Xenova » Mon May 24, 2004 8:22 am

If you meant to ask me and not Wilson...

I don't know if I had a sickness or if it was the avonex or if it was both. In March and April, I was extremely fatigued, had cold-like symptoms, and had no energy.

Anyway, I do feel better today. I'll see how the week goes.
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Postby Shayk » Mon May 24, 2004 7:18 pm

Well, I really meant to ask both of you. :oops:

Glad you're doing better today. It's quite the conundrum to not be able to figure out if it's the "good" Avonex making you (and me) feel bad or the "recalled" Avonex. :roll:

As for Wilson, I recalled when he first posted that he had a "whole lot of shaking" going on. So, Wilson, are you still doing a whole lot of shaking? Or, are the side effects calming down?

Take care all.

Sharon
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Postby Xenova » Tue May 25, 2004 8:10 am

I am going to call my pharmacist today to see what happened. I'm perturbed that since there is a recall, why weren't these boxes recalled? Why did the tainted solution end up in my body? Did BioGen Idec notify them to let them know? It seems like all they did was file the papers with the FDA. I hope they have a better communications procedure than this if they ever send out a more dangerous batch of Avonex.
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Postby willysnout1 » Tue May 25, 2004 12:08 pm

Shayk, a question: I just went and checked my box of Avonex, which comes to me via Nova Factor. There is no lot number on the from of the box but it was stamped on one side and on the peel-off containers on easy tray inside. How were you able to identify your Avonex as being "from the recall?" You said you got it from the box front, but it's not on the front of the box that I have.

Xenova, from what I have read this does not seems to be an issue of the drug being "tainted." It seems like they put too much of the liquid into some of the syringes. Frankly, it strikes me as quite a minor thing. It would be as if, in the powdered solution days, you mixed it with more water than they told you to. That's not the same as, say, the water being dirty or the drug being bad.

p.s.: And no, I don't own stock in Biogen and I'm not in love with Avonex. Just in case anyone is wondering. :) I'm one of these "just the facts, ma'am" kind of guys when it comes to the drugs. The issue is too important to be to be anything other than as accurate as possible in discussions.
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Postby Xenova » Tue May 25, 2004 2:18 pm

I just got off the phone with MSActive Source. They reassured me that this was not a safety issue. The recall was at the wholesale level. The FDA did not think it was necessary to recall Avonex at the retail or consumer level. It was okay if patient's used the syringes. Biogen did a voluntary recall from wholesalers so that they could replace it with a product that me their quality objectives.

I guess I was feeling bad for some other reason.

The lot number was stamped on my box and it is also on the side of the syringe.

One day, we will not have to bother with all of this.
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Postby willysnout1 » Tue May 25, 2004 2:52 pm

I posted my message on another Internet board and am told that "excess aggregates" is not the same thing as too much fluid in the syringes. I'm going to keep looking for information, but my posting about the liquid was plain wrong. Might as well say so right now. :(
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Postby Shayk » Tue May 25, 2004 6:48 pm

Well, I do wish we'd get to the bottom of this. One of my colleagues is a pharmacist. When I first learned about the recall I tried to casually inquire about how bad FDA recalls might be. :roll:

According to her, the FDA has different classes of recalls. When we looked at the FDA info she said it was a Class 1 recall which usually means that it goes all the way to the patient.

Interestingly enough however, when we went to the FDA site (last Friday), the Avonex recall was not listed on the page which supposedly contains all of the recalls within a certain period of time. We did eventually find it though through a link. :roll:

So, I'm still totally confused and befuddled by all of this.

Sharon
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very grateful for Avenox

Postby wilson » Wed May 26, 2004 4:54 pm

Hi Sharon


Thank you for the query about how I am handling Avenox. The shakes have toned down to the chills and the heavy achy feeling all now only lasts for about 20 hours. I am hoping the effects will still keep subsiding.

As for Avenox, I am very grateful that my insurance company covers the cost. I know that some folks do not have the opportunity to take Avenox due to lack or no insurance. I don't like the side effects but I do believe that a modest average reduction is worth the jabbing and effetcs

I am sure looking forwrad to the new meds coming out. Yeh?
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very grateful for Avenox

Postby wilson » Wed May 26, 2004 4:56 pm

Hi Sharon


Thank you for the query about how I am handling Avenox. The shakes have toned down to the chills and the heavy achy feeling all now only lasts for about 20 hours. I am hoping the effects will still keep subsiding.

As for Avenox, I am very grateful that my insurance company covers the cost. I know that some folks do not have the opportunity to take Avenox due to lack or no insurance. I don't like the side effects but I do believe that a modest average reduction is worth the jabbing and effetcs

I am sure looking forwrad to the new meds coming out. Yeh?
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Postby Shayk » Wed May 26, 2004 6:33 pm

Wilson, so glad to hear the side effects are less. :)

I can't remember if I mentioned this before, but your "whole lot of shakin" going on stuck with me because I identified with it 100%. My first night I actually wondered if I was having a seizure I was shaking so bad. :roll:

I have insurance too so count myself among the lucky, and yes, I will be very glad when Antegren hits the streets (assuming it will), but I have to tell you my neuro said he would add it to the Avonex, so I have the distinct impression I'll be on both Antegren and Avonex. :roll:

We'll see. Take care Wilson.

Sharon
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avonex

Postby epfcat » Thu May 27, 2004 10:35 am

Hi,

First time poster here. I've had this oh-so-UN-fun disease for about seven years now.

The side effects of the Avonex DO lessen over time, as your body gets used to it. At the beginning, I was only taking .5ml because my fevers/flu-like symptoms were so bad. After awhile, we eased up the dosage. Now I just take 1200mg of ibuprofin after injecting and things seem to be okay, so persevere if you can.

I am unusual in that I now inject twice a week- but it's been super helpful in staving off the relapses.
epfcat
 

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