FDA warns of risk of death associated with multiple sclerosis drugs
The U.S. Food and Drug Administration (FDA) has warned the public about a rare but serious allergic reaction associated with popular multiple sclerosis drugs.
The risk of anaphylaxis is associated with glatiramer acetate, sold under the brand names Copaxone and Glatopa. In some cases, the negative reaction can be life-threatening and some patients have been hospitalized or died after taking the drugs, which are typically administered as an injection.
The FDA said it identified 82 worldwide cases of anaphylaxis associated with glatiramer acetate, occurring from December 1996 through May 2024, all found either through reports submitted to the agency or a review of the literature. Perhaps most concerning, 19 cases are linked to patients who had been on the medication for more than a year.
Given the delayed onset of allergic reactions, the FDA is asking providers to educate patients on symptoms of anaphylaxis, including flushing, chest pain, palpitations, anxiety, shortness of breath, rash and hives.
In the case of glatiramer acetate, a serious allergic reaction is typically seen within an hour after injection. However, identifying signs is complicated by normal post-injection side effects that mirror a histamine reaction, yet dissipate on their own in 15-30 minutes, the FDA said.
If the symptoms last longer, however, they could progress into shock. Medical intervention is then necessary, due to a high risk of death.
Despite the risks, the FDA is not questioning the general safety and efficacy of these drugs. Rather, it is simply warning that there could be life-threatening side effects for a small number of patients, as is the case with many medications.
The agency said it intends to add a warning label to the products to increase awareness among providers and patients.
The full notice can be found here.
Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.