United States: The U.S. Food and Drug Administration now highlights rare severe allergic reactions that can happen with MS drugs such as Teva’s (TEVA.TA) Copaxone.
Anaphylaxis Risk with MS Treatment
The FDA’s top warning mechanism now requires medicines to display that severe allergic reaction called anaphylaxis may develop during or after long-term use of the drug starting from the first dose, as reported by Reuters.
The medication glatiramer acetate treats patients with relapsing forms of multiple sclerosis who have this chronic disease of the central nervous system.
FDA Adds a Boxed Warning on Rare, Serious Allergic Reaction to Glatiramer Acetate (COPAXONE, GLATOPA) Product Labeling pic.twitter.com/hhzEDznDWd
— Pyrls (@PyrlsApp) January 23, 2025
Teva offers Copaxone as a brand drug while Sandoz (SDZ.S) produces the generic edition called Glatopa.
Both companies chose not to reply to our comment requests.
According to the FDA report most patients who received anaphylaxis injections showed symptoms within the first hour of treatment. The FDA added some patients needed hospitalization and died.
Reported Cases and Outcomes
The health regulator recorded 82 worldwide cases of anaphylaxis that developed in patients who received Copaxone from December 1996 to May 2023 including 19 users who experienced anaphylaxis more than one year after starting the medicine.
Multiple Sclerosis Drug Copaxone Gets FDA “Black Box Warning” After Deaths From Allergic Reactions#Copaxone #Glatopa #Anaphylaxishttps://t.co/h0Lf5afVAh
— AboutLawsuits.com (@AboutLawsuits) January 23, 2025
Under FDA documents patients required hospital stays or emergency rooms because of medical problems that ended in the deaths of six patients.
Teva and Sandoz Decline Comment
Some patients develop wheezing and breathing troubles with facial swelling that could cause throat or lip swelling alongside hives. These symptoms lead to life-threatening shock, which starts as a severe rash, as reported by Reuters.
Teva's multiple sclerosis stalwart Copaxone gets FDA boxed warning for anaphylaxis risk https://t.co/iin7njJDKs
— FiercePharma (@FiercePharma) January 23, 2025
Visit an emergency room immediately when side effects following treatment persist beyond a short duration or worsen according to FDA recommendations.
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