FDA Adds Boxed Warning to MS Drug Copaxone

The FDA has released a Drug Safety Communication and added a boxed warning to the prescribing information about the risk of a rare but serious allergic reaction to Teva’s Copaxone (glatiramer acetate) and its generic, marketed as Glatopa.

Copaxone was first approved by the FDA in 1996, and Glatopa was approved in 2015. Both are used to treat patients with multiple sclerosis, and they work by lessening the immune system’s abnormal attack on nerves in the brain and spinal cord. This helps decrease the number of MS relapses.

Multiple sclerosis impacts the brain and spinal cord. In patient with MS, the immune system attacks myelin, the protective layer of nerve fibers. It causes problems with vision, arm and leg movement and balance.

Anaphylaxis associated with the use of glatiramer acetate can occur at any time during treatment. For most people, symptoms appeared within one hour of injection. In some cases, anaphylaxis resulted in hospitalization and death. About 1 million people in the United States have multiple sclerosis.

In 2023, an estimated 240,000 glatiramer acetate prescriptions were dispensed and estimated 32,000 patients received a dispensed prescription from U.S. outpatient retail and mail order pharmacies, according to Symphony Health Metys.

Initial symptoms of anaphylaxis might overlap with post-injection reactions, which are transient and self-limited reactions that can happen shortly after an injection of the medicine into the skin.

FDA officials identified 82 worldwide cases of anaphylaxis associated with glatiramer acetate from December 1996 through May 2024. These cases were reported to the FDA Adverse Event Reporting System. These patients reported serious outcomes that required emergency room visits or hospitalizations for medical treatment, and six patients died. A majority of the 82 patients experienced anaphylaxis within one hour of taking the medicine.