The U.S. Food and Drug Administration (FDA) has issued a warning about severe allergic reactions, including anaphylaxis, that can occur with certain multiple sclerosis medications, such as Teva’s Copaxone and the generic Glatiramer acetate. The FDA is adding a new boxed warning to alert healthcare providers and patients that serious allergic reactions can happen at any time after starting these drugs.
The drugs are used to treat relapsing forms of multiple sclerosis, a chronic condition affecting the central nervous system. Copaxone, developed by Teva, has been linked to 82 reported cases of anaphylaxis from December 1996 through May 2024, including 19 cases occurring more than a year after starting the medication. Many patients experienced severe symptoms requiring hospitalization or died within weeks.
Symptoms such as wheezing, breathing difficulties, swelling, and hives can progress to life-threatening conditions like shock. Patients should seek immediate medical attention if they experience severe, worsening symptoms that do not improve quickly. The FDA emphasized that these drugs pose a significant risk of anaphylaxis compared to alternative treatments.
For more details, contact the companies directly as they did not respond immediately to the request for comment.
Source: https://www.reuters.com/business/healthcare-pharmaceuticals/fda-warns-serious-allergic-reactions-with-multiple-sclerosis-drugs-2025-01-22