FDA Adds Anaphylaxis Warning to MS Drug Glatiramer Acetate

The US Food and Drug Administration (FDA) has added a boxed warning to the label of multiple sclerosis drug glatiramer acetate about the risk of anaphylaxis.

From December 1996 through May 2024, 82 cases of anaphylaxis associated with glatiramer acetate were reported to the FDA Adverse Event Reporting System.

Anaphylaxis associated with glatiramer acetate can occur at any time while on treatment, after the first dose or after doses administered months or years after starting the medicine, the FDA said in a drug safety communication. 

In fact, 19 of the reported cases occurred more than 1 year after starting the medication. The median time to onset of anaphylaxis from starting glatiramer acetate was 5 months.

Of the 82 patients, 51 were hospitalized for anaphylaxis; of those 51, 13 required intensive care and 6 died.

Initial symptoms of anaphylaxis associated with glatiramer acetate can overlap with those of immediate post-injection reactions. 

“While immediate post-injection reaction is common, anaphylaxis is rare and its symptoms are typically more severe, worsen over time, and require treatment,” the FDA noted. 

The FDA calls on health care professionals to educate patients on the signs and symptoms of anaphylaxis and immediate post-injection reactions. Patients should be advised to seek immediate medical attention if they experience any symptoms of anaphylaxis.

The 82 cases of anaphylaxis with glatiramer acetate include only reports submitted to FDA and found in the medical literature, “so there are likely additional cases about which we are unaware,” the agency said.