FDA issues anaphylaxis warning on multiple sclerosis treatment

The FDA has advised health care professionals and patients with multiple sclerosis that treatment with glatiramer acetate is associated with a risk for anaphylaxis and issued a new boxed warning, according to a drug safety communication.

All patients on glatiramer acetate (Copaxone, Glatopa), as well as health care professionals, should know of this rare serious allergic reaction as the FDA said it can happen following a first dose or following doses given years since the start of treatment.

Notably, within 1 hour of injection is the typical time frame in which symptoms of anaphylaxis — “wheezing or difficulty breathing, swelling of the face, lips or throat and hives” — occur, according to the safety communication.

The FDA also noted overlap between initial anaphylaxis symptoms and immediate post-injection reaction and recommended “immediate medical attention if the symptoms [of a reaction after receiving glatiramer acetate] are more than mild, get worse over time or do not go away within a brief time.”

Hospitalization and death are possible outcomes among patients who experience anaphylaxis, emphasizing the significance of quick action when symptoms are present, the safety communication stated.

The FDA wrote that this addition to the boxed warning on glatiramer acetate is based, in part, on the discovery of 82 worldwide cases of anaphylaxis between December 1996 and May 2024 that have been linked to the treatment. Death occurred in six of the 82 patients.

The safety communication also advised physicians to educate their patients about the signs and symptoms of immediate post-injection reactions and of anaphylaxis, with instructions to stop taking glatiramer acetate and go to an ED or call 911 when anaphylaxis occurs.

Health care professionals and patients who experience side effects when using medication should report them to the MedWatch Adverse Event Reporting program, the FDA said.