By THOMAS GRYTA
Amgen Inc. is recalling certain lots of anemia drugs Epogen and Procrit, sold by Johnson & Johnson, because they may contain "extremely thin" glass flakes that are barely visible.
The recall includes about 200 lots of Epogen, Amgen spokeswoman Emma Hurley said, but shouldn't disrupt the supply of the drug to patients, nor will it have a material financial impact on the company.
Both drugs are the same product, epoetin alfa, which Amgen produces and markets as Epogen for kidney-failure patients on dialysis and has licensed other uses of the drug to J&J, which sells it as Procrit.
Amgen said the problem with the flakes occurs as a result of the interaction of the medications with glass vials over the shelf life of the product. In response, Amgen is reducing the shelf life of Epogen to 12 months, from 36 months, for single-dose vials and 15 months for multiple-dose vials.
Furthermore, the company will begin using glass vials from one of its manufacturers "that doesn't exhibit the issue before the expiry date," Ms. Hurley said. The company uses multiple suppliers to provide glass vials, but it couldn't immediately comment on the source of the problematic vials.
J&J spokeswoman Lisa Vaga wouldn't comment on the financial impact of the recall, but she said the company will do "everything we can to ensure customers and patients continue to have access to Procrit."
Amgen's sales of Epogen in the U.S. last year were $2.6 billion. Johnson & Johnson had global sales of Procrit, and a similar product called Eprex, of $2.2 billion last year.
J&J has had a series of product recalls since late last year because of quality problems, which have tarnished its image and hurt its financial results. The company has battled the problems by improving quality-control measures and is refitting one of its plants related to the problems.
The recall is being conducted in cooperation with the Food and Drug Administration.
The glass flakes are barely visible in most cases, and the companies "found a low potential to impact patients who may have received the affected product" and have received no reports of problems that "can be directly attributed" to the problem.
Regardless, the companies warn that particles in an injectable product can cause serious side effects. Amgen and J&J are sending letters and other communication to health-care professionals, distributors, wholesalers and pharmacies, with instructions for returning the products.
Affected lot numbers and expiration dates can be found at the drugs' websites, www.epogen.com and www.procrit.com.
Seriously, though what's the plan now to keep it up (your hgb ;) that is) with the big Epo/Procrit recall?
Were you able to get any more, or what's the team's plan B for you? Wondering what your tx folks are saying -- I'm still waiting to hear what plan B is here if hubby's hgb goes below 10 again with no Procrit. ~eureka
being in the 9s is much better on the way up then the way down
Yup! You got that right! It takes a drop down to 8 or so to make you appreciate the free wheeling glory of the 9's.
Ouch I hated being in the 9s but compared to where you have been yes I bet it does feel so much better going up rather than down......(I can hear the boys making something out of that statement but you know what I mean on all sides there ;)
At hgb at nine-something, I don't think I was up to cuddling, and certainly not very conversant. Glad you are feeling better.
It went up too 9.8 and then a week later 9.2. I feel a lot better. I can't believe the difference after 4 once weekly injections. I feel like I am alive again. being in the 9s is much better on the way up then the way down as I think you mentioned in one of your posts I've read. I guess it's all relative.
Thanks for asking!
Dave what is your hemo up to now?
Awww :). It's nice to see you guys showing your 'tender' side (be it cuddly or talkative). lol
But gosh, fellas, at least in this bed, be it my side or his, it's a lot of things, but never an obligation! :|
“When I have a "headache" I still feel obliged to say yes, even when all I really want is to cuddle”
You forgot the talking part. There are times when all we want is to cuddle and talk (LOL). But we sacrifice and fulfill our obligations
When I have a "headache" I still feel obliged to say yes, even when all I really want is to cuddle!
Maybe it is to come clean and explain to her that full time nooky was the deal. SICKNESS OR HEALTH. Actually the nooky should be registered in your name. If it is registered, you own it.
Headaches before or after! Not a lot of progress for a million years of evolution. Looks like women be doomed to have headaches.
With hgb at seven you'd lose consiousness as soon as you rose to the occassion. Only enough red corpuscles for one head at a time, I think.
Yeah. But when the ladies be in my cave, the ladies bemoaning. They know impotent when they see it.
"Ambien and roofies -- so easy, even a caveman can do it..." :o)
'Tis a counter-productive technology if the improvement in clubbing method still has the little lady bemoaning of headaches... less lumps for her, but still lumps for you.
FLguy: Never in the right place but always more than needed.
Are you sure that's your punctuation? Sounds more like good use of the ol' stromboli to me.
Merry: a little effort will raise your white count....
More likely to raise the ol' white stromboli, if you ask me.
Eureka: "the use of ambien and roofies is by men with no skill,
'tis simply technology's improvement on the caveman and the club. Yeah, so you still get the headache, but fewer lumps to deal with.
"you'd have ask the wife how she feels about vinyl menage. "
LMAO, you're giving FLGuy and Goofy a run for their money!
RGlass....ROFL!!!! You're very generous ;)
spectda: It could go something like this. (If you leave the part about you being bored with your wife. We all know she's a saint for putting up with the backhair 'do)(ok...it might not be anything like this...but it just struck me as funny--spectda and his hand-me-down friend from Glass)
http://www.youtube.com/watch?v=QVdhZwK7cS8
Omgoodness....y'all have made my day. Thanks for the laugh.
"are they mutually exclusive?"
-----------------
Not if the shoe (or doll) fits.
Of if you mean wife vs inflatable, you'd have ask the wife how she feels about vinyl menage.
R Glass: LOL
Yeah, yeah, we see right through you...
nooky...........haven't heard that since high school
“R Glass-
Very thoughtful of you!”
I’m here for you Brother.
Wait!!!!!! That didn’t come out the way I meant it.LOL
Isobella-
So the inflatable doesn't need any ambien? Does it want coffee and chocolate?
R Glass-
Very thoughtful of you!
Eureka-
"the use of ambien and roofies is by men with no skill, lacking in imagination, or those who never grew out of the desire for the inactivity of inflatables."
are they mutually exclusive?
Merry-
"besides, a little effort will raise your white count....another good thing."
The less neupogen needed argument, good thinking!
- Dave
"You call it "nooky"?
That may be part of the problem. "
Well we have the medhep version and the other version...
"I vote you save the ambien and go with the inflatable"
I can send him mine, I just bought a new one. She’s a little old but she cleans up well.