FDA: Anaphylaxis Risk Prompts Boxed Warning for MS Drug

Reports of anaphylaxis associated with the use of glatiramer acetate have prompted the Food and Drug Administration (FDA) to add a Boxed Warning to the prescribing information.

Marketed under the names Copaxone and Glatopa, glatiramer acetate is indicated for the treatment of relapsing forms of multiple sclerosis (MS). Worldwide, there have been 82 cases of anaphylaxis reported with glatiramer acetate use since December 1996, though additional cases have likely gone unreported, according to the FDA. Most of these patients experienced anaphylaxis within 1 hour after injection and required emergency room visits or hospitalization for treatment; 6 of these individuals died.  

Though the incidence of glatiramer-associated anaphylaxis appears rare, the FDA has added the Boxed Warning to the product labeling in order to make clinicians and patients aware of the potential risk. Specifically, patients should be educated on the signs and symptoms of anaphylaxis and how they differ from common immediate post-injection reactions. Anaphylaxis can occur at any time during treatment. Among the 82 reported anaphylaxis cases, 19 occurred more than 1 year after initiating the medication.

The FDA recommends that patients who experience symptoms of an anaphylactic reaction after administering glatiramer acetate should seek immediate medical attention. Clinicians are advised not to restart the medication unless an alternative cause for the anaphylaxis has been identified. 

Adverse events involving glatiramer acetate should be reported to the FDA’s MedWatch program.

This article originally appeared on MPR