FDA Warns Of Severe Allergic Reaction Risk With Teva's Multiple Sclerosis Drug

The U.S. Food and Drug Administration (FDA) has issued a warning regarding the risk of anaphylaxis, a rare but severe allergic reaction associated with glatiramer acetate, a medication used to treat relapsing forms of multiple sclerosis (MS).

Anaphylaxis can occur at any time during treatment, even years after the initial dose, and may result in hospitalization or, in rare cases, death. A new Boxed Warning highlighting this risk has been added to the drug's prescribing information and patient guides.

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Glatiramer acetate, sold under the brand name Copaxone by Teva Pharmaceuticals Industries Ltd TEVA and as generics like Glatopa, is an injectable medication designed to reduce the frequency of MS relapses.

While effective, the FDA noted 82 cases of anaphylaxis reported worldwide between 1996 and 2024, with six resulting in fatalities. Most incidents occurred within one hour of injection, underscoring the importance of recognizing early symptoms such as difficulty breathing, facial swelling, hives, and severe rash.

Patients are advised to seek immediate medical attention if symptoms of anaphylaxis occur. Early signs may overlap with a less severe, common reaction called an immediate post-injection reaction, which typically resolves on its own within 15–30 minutes.

However, unlike post-injection reactions, anaphylaxis symptoms often worsen over time and require urgent intervention.

The FDA recommends that patients discontinue the medication and avoid restarting it if anaphylaxis occurs unless another cause for the reaction is identified.

Healthcare providers are encouraged to educate patients about distinguishing between mild injection reactions and potentially life-threatening anaphylaxis.

Providers should also monitor for signs of anaphylaxis during treatment and avoid reinitiating the drug in affected patients without further evaluation.

This warning serves to ensure patient safety and prompt recognition of serious allergic reactions, particularly as anaphylaxis can develop even after long-term use of glatiramer acetate.

Price Action: TEVA stock is down 2.07% to $21.56 at the last check of Thursday.

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Image via Teva Pharmaceutical Industries