FDA

FDA adds boxed warning for MS drug

January 23, 2025

FDA issued a new Boxed Warning for glatiramer acetate (Copaxone, Glatopa), an injectable medication for relapsing multiple sclerosis (MS), due to the risk of anaphylaxis. This reaction can occur at any time during treatment, even years after starting the medication.

The warning is based on 82 reported cases of anaphylaxis from December 1996 to May 2024. Nineteen cases occurred more than a year after starting treatment, with a median onset of 5 months. Most reactions happened within an hour of injection, including one case of shock and sudden death after the first dose.

Health care professionals should educate patients on recognizing anaphylaxis and differentiating it from common immediate post-injection reactions. Symptoms typically appear within an hour and include wheezing, difficulty breathing, swelling of the face, lips, or throat, and hives. Severe cases can lead to hospitalization or death. FDA advises immediate medical attention if these symptoms occur and to stop the medication if anaphylaxis is suspected.

Source:

(2025, January 22). FDA. FDA adds Boxed Warning about a rare but serious allergic reaction called anaphylaxis with the multiple sclerosis medicine glatiramer acetate (Copaxone, Glatopa). https://www.fda.gov/drugs/drug-safety-and-availability/fda-adds-boxed-warning-about-rare-serious-allergic-reaction-called-anaphylaxis-multiple-sclerosis