The U.S. Meals and Drug Administration (FDA) has issued a warning concerning the danger of anaphylaxis, a uncommon however extreme allergic response related to glatiramer acetate, a drugs used to deal with relapsing types of a number of sclerosis (MS).
Anaphylaxis can happen at any time throughout therapy, even years after the preliminary dose, and should lead to hospitalization or, in uncommon instances, dying. A brand new Boxed Warning highlighting this threat has been added to the drug’s prescribing info and affected person guides.
Additionally Learn: Teva Challenges Drug Worth Legislation’s Impression On Innovation, Generics
Glatiramer acetate, bought below the model title Copaxone by Teva Prescribed drugs Industries Ltd TEVA and as generics like Glatopa, is an injectable treatment designed to scale back the frequency of MS relapses.
Whereas efficient, the FDA noted 82 instances of anaphylaxis reported worldwide between 1996 and 2024, with six leading to fatalities. Most incidents occurred inside one hour of injection, underscoring the significance of recognizing early signs equivalent to problem respiration, facial swelling, hives, and extreme rash.
Sufferers are suggested to hunt rapid medical consideration if signs of anaphylaxis happen. Early indicators might overlap with a much less extreme, widespread response referred to as an instantaneous post-injection response, which generally resolves by itself inside 15–half-hour.
Nonetheless, in contrast to post-injection reactions, anaphylaxis signs usually worsen over time and require pressing intervention.
The FDA recommends that sufferers discontinue the treatment and keep away from restarting it if anaphylaxis happens except one other trigger for the response is recognized.
Healthcare suppliers are inspired to coach sufferers about distinguishing between gentle injection reactions and probably life-threatening anaphylaxis.
Suppliers also needs to monitor for indicators of anaphylaxis throughout therapy and keep away from reinitiating the drug in affected sufferers with out additional analysis.
This warning serves to make sure affected person security and immediate recognition of significant allergic reactions, significantly as anaphylaxis can develop even after long-term use of glatiramer acetate.
Worth Motion: TEVA inventory is down 2.07% to $21.56 on the final test of Thursday.
Learn Subsequent:
Picture by way of Teva Pharmaceutical Industries
This content material was partially produced with the assistance of AI instruments and was reviewed and revealed by Benzinga editors.
Market Information and Knowledge delivered to you by Benzinga APIs
© 2025 Benzinga.com. Benzinga doesn’t present funding recommendation. All rights reserved.
