New warning about glatiramer acetate

The EMA is the source of the information in this article:




From Medscape (July 14, 2024)--"EMA Warns of Anaphylactic Reactions to MS Drug":





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:

Cases involving the use of glatiramer acetate with a fatal outcome have been reported, PRAC [the EMA's Pharmacovigilance Risk Assess Committee] noted.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.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.

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.

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 And instead of the previous advice about how anyone having an IPIR should just calm down and let it pass has been replaced by advising people to seek immediate medical attention.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?"





https://www.healthcentral.com/condition/mulitple-sclerosis/copaxone-for-ms-side-effects

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::





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.

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":





This reaction is possible at any time during treatment as the article notes. 

Anaphylaxis can occur at any time during treatment. Among the 82 reported anaphylaxis cases, 19 occurred more than 1 year after initiating the medication.

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":