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DIR Return to: COPAXONE, GLATOPA (glatiramer acetate)
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#Post#: 4484--------------------------------------------------
New warning about glatiramer acetate
By: agate Date: July 14, 2024, 1:05 pm
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The EMA is the source of the information in this article:
HTML https://bit.ly/3zG7cfr
From Medscape (July 14, 2024)--"EMA Warns of Anaphylactic
Reactions to MS Drug":
HTML https://bit.ly/3zQS6n5
When I first started on Copaxone (2007) I was concerned about
the immediate post-injection reaction (IPIR) some people were
having. The people at the support line, Shared Solutions,
assured me that it was always temporary and usually required no
medical attention. When I asked if this was an allergic
reaction, the answer was that it would be impossible to have an
allergic reaction to this drug, but that the IPIR was "like an
allergic reaction."
Nevertheless, over the years some people have been saying
they've had an allergic reaction to glatiramer. And now it seems
that there can indeed be an allergic reaction to it, even
anaphylaxis--and apparently even fatal anaphylaxis though this
part of the article isn't entirely clear:
[quote]
[font=proxima_nova_rgregular]Cases involving the use of
glatiramer acetate with a fatal outcome have been reported, PRAC
[the EMA's Pharmacovigilance Risk Assess Committee]
noted.[/font][font=proxima_nova_rgregular]The committee
cautioned that because the initial symptoms could overlap with
those of postinjection reaction, there was a risk for delay in
identifying an anaphylactic
reaction.[/font][font=proxima_nova_rgregular]PRAC has sanctioned
a direct healthcare professional communication (DHPC) to inform
healthcare professionals about the risk. Patients and caregivers
should be advised of the signs and symptoms of an anaphylactic
reaction and the need to seek emergency care if this should
occur, the committee added. In the event of such a reaction,
treatment with glatiramer acetate must be discontinued, PRAC
stated.[/font]
[/quote]
[font=proxima_nova_rgregular]So does this mean that everyone
using glatiramer who has an IPIR should get medical attention
for it? It sounds as if patients are going to be carefully
instructed in how to differentiate an anaphylactic reaction from
an "ordinary" IPIR. This could be tricky when someone is in the
midst of an IPIR.[/font]
#Post#: 4506--------------------------------------------------
Changes in the way glatiramer acetate is being presented
By: agate Date: August 5, 2024, 6:35 pm
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I ran across this material about Copaxone recently. Interesting
that the IPIR that was previously always described as "not an
allergic reaction but like an allergic reaction" is now being
called an allergic reaction. And instead of the previous advice
about how anyone having an IPIR should just calm down and let it
pass has been replaced by advising people to seek immediate
medical attention.
From HealthCentral newsletter (July 31, 2024)--"What are the
side effects of Copaxone for multiple sclerosis?"
HTML https://www.healthcentral.com/condition/mulitple-sclerosis/copaxone-for-ms-side-effects
#Post#: 4688--------------------------------------------------
FDA adds boxed warning to GA over risk of rare serious reaction
By: agate Date: January 23, 2025, 12:49 pm
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Now glatiramer acetate will have a boxed warning. Over 80
people have had genuine anaphylactic shock reactions to this
drug, 51 were hospitalized, 13 required intensive care, and 6
have died. The reaction is rare but it does happen.
From PharmacyTimes (January 23, 2025)--"FDA adds boxed warning
to glatiramer acetate over risk of rare, serious allergic
reaction::
HTML https://www.pharmacytimes.com/view/fda-adds-boxed-warning-to-glatiramer-acetate-over-risk-of-rare-serious-allergic-reaction
This information was picked up by at least 10 online reporting
sites in the last couple of days. It is probably regarded as
important news from a business standpoint. Glatiramer has often
been touted as the safest of the MS drugs.
Reading message board posts over the years, though, I was struck
by the number of posts describing "immediate post-injection
reactions" that sounded far more serious than described by the
drug company. It is easy to shrug off message board posts as
possibly coming from someone who is exaggerating. My guess is
that at least some of those posts weren't exaggerated
statements.
#Post#: 4701--------------------------------------------------
FDA's boxed warning of anaphylaxis risk
By: agate Date: February 5, 2025, 2:09 pm
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The recently added boxed warning has been getting considerable
attention, and here is some more.
From Neurology Advisor (February 5, 2025)--"FDA: Anaphylaxis
risk prompts boxed warning for MS drug":
HTML https://www.neurologyadvisor.com/news/fda-anaphylaxis-risk-prompts-boxed-warning-for-ms-drug/
This reaction is possible at any time during treatment as the
article notes.
[quote][font=montserrat]Anaphylaxis can occur at any time during
treatment[/font][font=montserrat]. Among the 82 reported
anaphylaxis cases, 19 occurred more than 1 year after initiating
the medication.[/font][/quote]
#Post#: 4974--------------------------------------------------
(Abst.) Anaphylaxis and glatiramer acetate
By: agate Date: October 29, 2025, 1:35 am
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More on this.
From PubMed (October 28, 2025), abstract of an article by
authors at the US Food and Drug Administration--"Anaphylaxis and
glatiramer acetate":
HTML https://pubmed.ncbi.nlm.nih.gov/41139841/
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