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CENTER FOR DRUG EVALUATION AND RESEARCH
DIVISION of DRUG INFORMATION
Your source for the latest drug information. Know the moment it happens.
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FDA Warns of Rare But Serious Allergic Reaction With a Multiple Sclerosis Medicine
Today, FDA released a Drug Safety Communication warning patients and health care professionals of the risk of a rare but serious allergic reaction (anaphylaxis) with glatiramer acetate (Copaxone, Glatopa), used to treat multiple sclerosis.
Anaphylaxis can occur at any time during treatment. For most people who experienced anaphylaxis while using glatiramer acetate, symptoms appeared within one hour of injection. In some cases, anaphylaxis resulted in hospitalization and death.
Initial symptoms of anaphylaxis might overlap with immediate post-injection reactions, which are transient and self-limited reactions that can happen shortly after an injection of the medicine into the skin. This could lead to a delay in recognizing and treating an anaphylactic reaction.
If you are taking glatiramer acetate, talk to your health care professional about the risks and benefits of receiving it and discuss any questions or concerns you may have, including about possible alternative treatments.
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