The U.S. Food and Drug Administration (FDA) has added a boxed warning, its most serious safety alert, to glatiramer acetate, a commonly prescribed medication for relapsing forms of multiple sclerosis (MS), due to the risk of anaphylaxis. This warning affects both the brand-name drug Copaxone (Teva Pharmaceutical) and its generic versions, including Glatopa (Sandoz). The FDA's decision follows a review of post-market safety data, which revealed instances of severe allergic reactions occurring even after prolonged use of the drug.
The FDA identified 82 cases of anaphylaxis worldwide over the past 28 years associated with glatiramer acetate. Although rare relative to the drug's widespread use, these reactions were serious, necessitating emergency room visits or hospitalizations in all cases. Six patients died. A majority of these reactions occurred within one hour of injection, but some occurred after patients had been taking the medication for more than a year.
Understanding the Risk
Anaphylaxis is a severe, potentially life-threatening allergic reaction that can manifest with symptoms such as difficulty breathing, swelling of the face or throat, hives, and shock. The FDA emphasizes that anaphylaxis associated with glatiramer acetate can be challenging to identify because its initial symptoms may resemble immediate post-injection reactions, a temporary and common side effect of the drug. However, anaphylaxis tends to worsen over time and presents with more severe symptoms.
The FDA advises healthcare professionals to educate patients about the signs and symptoms of anaphylaxis and to instruct them to seek immediate medical attention if they experience any concerning symptoms after injecting glatiramer acetate. Patients who have experienced anaphylaxis related to glatiramer acetate should not restart the therapy.
Context of Multiple Sclerosis Treatment
Glatiramer acetate is an injectable therapy used to reduce the frequency of relapses in patients with relapsing forms of MS, an autoimmune disorder affecting the central nervous system. Teva Pharmaceutical's Copaxone was initially approved in 1996, and generic versions have since become available. Clinical trials have demonstrated that glatiramer acetate can reduce the number of relapses by approximately 34% compared to placebo.
The new boxed warning highlights the importance of vigilance and patient education in managing the risks associated with glatiramer acetate therapy. While anaphylaxis is rare, its potential severity warrants careful monitoring and prompt intervention.
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) issued a similar notification in October 2024 regarding the risk of anaphylactic reactions with glatiramer acetate.
