The U.S. Food and Drug Administration (FDA) has released a new Drug Safety Communication, placing a Boxed Warning on glatiramer acetate (Copaxone, Glatopa) for its serious but uncommon risk of anaphylaxis. The injectable medication, prescribed for treating relapsing forms of multiple sclerosis (MS), has been associated with life-threatening allergic reactions in a small number of patients.Key Highlights:
Risk of Anaphylaxis:

• Anaphylaxis may follow any dose of glatiramer. It can occur even years following initiation of treatment.

• Symptoms are wheezing, trouble breathing, swelling of the face or throat, and serious rash, which can lead to shock.

FDA Measures:

• A new Boxed Warning has been included in the prescribing information and patient Medication Guide.

• The FDA is calling on patients and physicians to distinguish between typical transient post-injection side effects and the more serious symptoms of anaphylaxis.

Recommendations for Caregivers and Patients:

• Discontinue glatiramer acetate right away and call emergency medical attention if signs of anaphylaxis develop.

• Early signs such as flushing, rash, or injection-site chest pain are usually transient but must be notified to healthcare professionals.

• Do not resume the drug unless advised by a medical practitioner.

Advice for Healthcare Professionals:

• Be vigilant for the risk of fatal anaphylaxis with glatiramer acetate, even many years after starting treatment.

• Educate patients on both the symptoms and signs of anaphylaxis and immediate post-injection reactions.

• Prevent the reinitiation of the drug in patients who have anaphylaxis unless there is another etiology.

Statements of Leaders or Officials:
FDA Communication:
The signs of such unusual anaphylactic reactions can overlap with usual post-injection reactions. It is imperative to inform patients and caregivers about the signs and act quickly," the FDA underlined.The FDA urges patients and healthcare professionals to report any adverse effects on the FDA's MedWatch Voluntary Reporting Program. The warning is intended to enhance awareness and boost patient safety for patients being treated for MS with glatiramer acetate.