FDA Issues Alert on Life-Threatening Allergic Reactions Linked to Common Multiple Sclerosis Drugs

Washington — The U.S. Food and Drug Administration has issued a public health alert concerning severe allergic reactions linked to certain multiple sclerosis medications. The agency highlights a heightened risk of anaphylaxis connected to glatiramer acetate, commercially known as Copaxone and Glatopa, which are commonly prescribed treatments that are administered by injection.

The FDA’s recent findings reveal a troubling connection between the drugs and anaphylactic reactions, some of which have proven fatal. Reports indicate that since the drug’s launch in December 1996 until May 2024, there have been 82 registered cases of such severe reactions globally. These cases involved individuals who experienced the onset of symptoms anywhere from their initial treatment to after a year of ongoing medication use.

Medical professionals are being urged by the FDA to thoroughly educate their patients on recognizing the warning signs of an allergic reaction. Symptoms can include a combination of flushing, chest pain, erratic heartbeats, anxiety, breathing difficulties, and skin irritations such as rashes and hives.

The complexity in diagnosing these reactions stems from their similarity to less severe side effects that occur post-injection, which typically subside within 15 to 30 minutes. However, when symptoms persist, they may escalate rapidly, advancing to shock and requiring urgent medical intervention to prevent potentially fatal outcomes.

Given the gravity and potential lethality of these reactions, the FDA’s alert aims to ensure both healthcare providers and patients using glatiramer acetate are fully aware and vigilant of the risks. The push for increased awareness is critical in providing immediate care should symptoms of anaphylaxis emerge.

The agency conveyed that while the occurrence of these reactions is relatively rare, the severity necessitates an informed and prepared response to safeguard patient health. The notice also underscores the importance of careful monitoring during the administration of injections and the period following.

The FDA continues its investigation into these severe reactions associated with glatiramer acetate and commits to updating the public and healthcare communities as new data emerges. This ongoing research is part of a broader effort to ensure the safety of pharmaceutical treatments that aim to improve the lives of patients battling multiple sclerosis.