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Author Topic: EpiPen Serious Manufacturing Violations  (Read 356 times)

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Offline spacecanada

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EpiPen Serious Manufacturing Violations
« on: September 07, 2017, 03:30:37 PM »
Just go ahead now and swallow some hot sauce; it might help make this go down easier.   :rant:

http://www.marketwatch.com/story/fda-warns-of-serious-manufacturing-violations-in-letter-to-epipen-manufacturing-facility-2017-09-07-141034838

Now I'm really wishing Allerject would return.  I know Canadian EpiPens are made by another company (Pfizer), but I have no doubt they get their parts from similar places, if not the exact same source. 

A good reminder to always carry two - and from two different lot numbers if possible.

anaphylaxis to tree nuts, peanuts, and potatoes; severe dairy intolerance; vegan (preference)
family members allergic to dairy, egg, peanut, sesame, shellfish

Offline rebekahc

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Re: EpiPen Serious Manufacturing Violations
« Reply #1 on: September 07, 2017, 03:56:05 PM »
 :rant: :rant: :rant:  As if I needed another reason to be disgusted with Mylan!

Just go ahead now and swallow some hot sauce; it might help make this go down easier.   :rant:

http://www.marketwatch.com/story/fda-warns-of-serious-manufacturing-violations-in-letter-to-epipen-manufacturing-facility-2017-09-07-141034838

Now I'm really wishing Allerject would return.  I know Canadian EpiPens are made by another company (Pfizer), but I have no doubt they get their parts from similar places, if not the exact same source. 

A good reminder to always carry two - and from two different lot numbers if possible.


Actually, I think they're the same probably even in Canada.  :-/ It may be that Pfizer gets to keep their name on the box there.

http://www.biospace.com/News/what-you-dont-know-pfizers-connection-to-mylan-and/430408

From the above link:
Quote
Although Mylan manufactures and sells the actual EpiPen device, Pfizer manufactures the drug the device administers. And although the financial deal between the two companies isn’t completely clear, Pfizer has shown increased revenues related to EpiPens for the last few years.


And from the MarketWatch link:
Quote
The Food and Drug Administration described “significant violations of current good manufacturing practice” in a warning letter to a Pfizer Inc. unit that manufactures Mylan NV’s EpiPen allergic reaction treatment.
TX - USA
DS - peanut, tree nut, milk, eggs, corn, soy, several meds, many environmentals. Finally back on Xolair!
DD - mystery anaphylaxis, shellfish.
DH - banana/avocado, aspirin.  Asthma.
Me - peanut, tree nut, shellfish, banana/avocado/latex,  some meds.

Offline GoingNuts

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Re: EpiPen Serious Manufacturing Violations
« Reply #2 on: September 07, 2017, 04:02:15 PM »
I just came on tonpost this.  Livid doesn't even begin to describe what I feel right now.   :rant:
"Speak out against the madness" - David Crosby
N.E. US

Offline PurpleCat

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Re: EpiPen Serious Manufacturing Violations
« Reply #3 on: September 07, 2017, 04:42:27 PM »
It was on my Facebook Feed today.   :rant: :rant: :rant: :rant:

Offline spacecanada

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Re: EpiPen Serious Manufacturing Violations
« Reply #4 on: September 07, 2017, 05:11:36 PM »
I'm just beyond words right now.  I figured it was all the same somehow: Mylan and Pfizer.   :rant:

Copying what I wrote in my local allergy group:

Allerject had similarly reported (though never publicly confirmed) dosing defects and recalled every single unit in North America, completely re-engineered their manufacturing process, and came back to market with a more reliable device (in America only). But, if EpiPen did that, we'd have nothing but phials and syringes like AnaKits before - not a situation anyone wants to be in. I'd rather have two devices with a 99% efficiency rate than a phial and syringe.

I just want to cry.  Seriously.  Like I need more anxiety over my allergies right now.  Allerject needs to come back to Canada.  Or we need a miracle cure.  Where can I get one of those?  :'(
« Last Edit: September 07, 2017, 05:13:19 PM by spacecanada »
anaphylaxis to tree nuts, peanuts, and potatoes; severe dairy intolerance; vegan (preference)
family members allergic to dairy, egg, peanut, sesame, shellfish

Offline CMdeux

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Re: EpiPen Serious Manufacturing Violations
« Reply #5 on: September 07, 2017, 08:26:44 PM »
 :grouphug:


Just a reminder to... as another poster mentioned upthread-- carry two from different lot numbers if you possibly can.

This is something that most of us old-timers have done for a couple of decades now, since the LAST big kerfuffle and recall back way before Mylan owned the brand, even.  It's a rescue med, and without it operating flawlessly... yeah-- bad, bad things happen.

If a device CANNOT fail you when you need it... plan accordingly.

It'd just really really be nice if we as consumers and patients had a little bit of help-- heck, even just "transparency" I'd settle for that-- from the manufacturers.

 :disappointed:
Resistance isn't futile.  It's voltage divided by current. 

Western U.S.

Offline Janelle205

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Re: EpiPen Serious Manufacturing Violations
« Reply #6 on: September 07, 2017, 09:18:47 PM »
Feeling really glad I decided to bite the bullet and go with the non-Mylan generic, though who knows if that is better.

Seriously considering asking for a vial and syringes as a back up. 
Allergic to soy, egg, tomato, apple, cherry, peach, pear, nectarine, canteloupe, watermelon, severe OAS to others, insect bites (severe to horseflies), various drugs, way too many environmental allergens, and asthma.

Offline ajasfolks2

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Re: EpiPen Serious Manufacturing Violations
« Reply #7 on: September 08, 2017, 09:59:12 AM »
Likely going to drive down to son at college and take him another set -- one composed of 2 different lots.  He had 2 sets to begin with, but one is with the travelling athletic people and 1 set with him.

I see now I should get another set to him -- split up from his sister's sets.


Effing Mylan.

Is this where I blame iPhone and cuss like an old fighter pilot's wife?

**(&%@@&%$^%$#^%$#$*&      LOL!!   

name

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Re: EpiPen Serious Manufacturing Violations
« Reply #8 on: September 14, 2017, 01:07:52 PM »
There are times (like now) I feel that the weight of public health bank perseverates on an emotional lifestyle PEANUT-NO PEANUT argument. 

Meanwhile...

  • FDA has massive clusterfudge in the autoinjector market.  No prevention, no competition, all too little, too late after-the-fact.  And where are the FDA at on sesame added to FALCPA? 
  • The ACAA might be amended to allow private right of action.  Yet the social conversation is still on nut bans on planes? 
  • EMS are not remotely in sync with epinephrine administration as convention plans indicate.  Training needs a significant overhaul for the recognition of anaphylaxis (and differentiation in assisted and/or adjunctive drugs when patients have comorbid asthma) to fully implement the intention behind the legislation to allow administration of epinephrine to the most basic scope.
  • Private practice OIT receives little attention compared to FARE/Aimmune CODIT and now FDA qualified health claims are allowed on labels that are based on promising evidence in very select segments.

This is no way directed at my doc.  He lives with the same or more that we do, and he has never fallen into the "PEANUT! PEANUT! PEANUT!" tar pit.

Offline LinksEtc

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Re: EpiPen Serious Manufacturing Violations
« Reply #9 on: September 15, 2017, 08:33:43 AM »
I know that I don't post much here anymore, but I think that I will update the sesame & FDA threads a bit over the next few days.

I am going to start a blog so most of my online activity will be that & Twitter (a new acct) ... I need to write ... this has been a really tough year for me ... my non-expert self-diagnosis is that I probably had some depression ... plus some of the hurts are still raw like losing my mom ... so I need to take things slow ...

the good news is that I am starting to feel my old spark back ... I have all these new books that I'm excited to read, I have all these thoughts that I can't wait to start exploring, I made reservations to visit Yosemite ...

anyway, I have to go ... spending the day with Grandma.





Offline nyguy

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Re: EpiPen Serious Manufacturing Violations
« Reply #10 on: September 18, 2017, 10:28:00 AM »
My cousins carry EpiPen and my aunt has been hesitant to switch to Auvi-Q. I know that EpiPen is the titan in the market (market share) and has history, but these revelations are troubling. Sanofi pulled Auvi-Q completely over a couple dozen reports (all lots) and it didn't return to the market for ~18 months.

Offline spacecanada

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Re: EpiPen Serious Manufacturing Violations
« Reply #11 on: September 20, 2017, 03:13:20 PM »
Anyone hear if Mylan/Pfizer issued a response to the FDA yet?  Would such a letter be made public?
anaphylaxis to tree nuts, peanuts, and potatoes; severe dairy intolerance; vegan (preference)
family members allergic to dairy, egg, peanut, sesame, shellfish

Offline my3guys

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Re: EpiPen Serious Manufacturing Violations
« Reply #12 on: September 20, 2017, 07:50:11 PM »
This whole thing has me wondering...dangerous I know. I'm thinking back to our incident last year in FL that I posted about. The whole thing definitely appeared like a reaction...first epi relieved symptoms for few minutes. Then they came roaring back. Gave second epi. Symptoms didn't get worse...but didn't subside for a while. By that time he'd been given IV Benadryl and we were in the ambulance. I expected more relief from the epi. It makes me wonder if all the fluid dispensed. It seemed like it worked at the time... we will never know at this point. Guess I should let this go...
« Last Edit: September 20, 2017, 07:51:42 PM by my3guys »

Offline momma2boys

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Re: EpiPen Serious Manufacturing Violations
« Reply #13 on: September 20, 2017, 09:41:09 PM »
My3guys, the thing is, we shouldn't have to wonder about that!
peanut, treenut, sesame
Northeast, US

Offline my3guys

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Re: EpiPen Serious Manufacturing Violations
« Reply #14 on: September 20, 2017, 09:48:59 PM »
Completely agree momma2!!