Multiple Sclerosis Drug Copaxone Gets FDA “Black Box Warning” After Deaths From Allergic Reactions

Following a half dozen patient deaths, federal drug regulators have added a “black box” warning to the label for the multiple sclerosis drug Copaxone and its generic version, Glatopa.

The U.S. Food and Drug Administration (FDA) announced the new warnings in a drug safety communication (PDF) issued on January 22. The agency called for the “black box” warning for the multiple sclerosis (MS) drugs after patients reported experiencing severe allergic reactions, known as anaphylaxis. The FDA has received 82 reports of patients suffering serious adverse health effects, including six reported deaths.

A “black box” warning is the FDA’s most serious type of warning it issues for medications. It is placed in the “Warnings and Precautions” section of the prescribing information of the drug box to indicate the drug may pose a serious risk of side effects, including death.

Copaxone (glatiramer acetate), manufactured by Teva Pharmaceuticals, was first approved in 1996 to treat relapsing forms of MS. It is also sold under the generic name Glatopa, made by Sandoz Group.

The drugs reduce the immune system’s abnormal attack on nerves in the brain and spinal cord to help decrease the number of relapses. The medications can be administered daily or three times per week.

The agency warned that there may be more cases of anaphylaxis from taking the drugs since the total only reflects the cases reported directly to the FDA.

Anaphylaxis occurs when the body experiences a severe response to an allergen. It requires medical attention, and patients who suffer the condition must be treated by a doctor. Symptoms tend to worsen over time and include wheezing, rash, nausea, vomiting, abdominal pain, swelling of the face, lips or throat, and hives. Symptoms can become more serious and include difficulty breathing, low blood pressure, rapid heart rate, loss of consciousness and shock.

The agency received 82 reports of anaphylaxis due to use of Copaxone or Glatoma from 1996 to May 2024. Of those cases, 19 occurred more than one year after the patient began taking the medication.

Most patients experienced anaphylaxis within one hour of taking the medication, but some occurred much later, weeks to months after they began taking the medication. The FDA highlighted the danger that anaphylaxis can occur at any time while being treated with the drug, urging patients to watch out for the symptoms.

The agency warns that anaphylaxis symptoms can resemble those of an immediate post-injection reaction, which is temporary and occurs only right after receiving the medication. This reaction typically resolves within 15 to 30 minutes and may include rash, hives, chest pain, palpitations and shortness of breath.

Patients experiencing symptoms of anaphylaxis should stop taking the drug and seek immediate medical attention by going to the emergency room or calling 911. Patients who have experienced anaphylaxis should not take the drug again.

Anyone who has experienced anaphylaxis or serious side effects from taking Copaxone or Glatopa should contact their doctor and report the side effects to the FDA’s MedWatch Adverse Event Reporting program.