MS drug glatiramer acetate given warning over allergic reaction risk
FDA recommends patients, providers be educated about anaphylaxis
The U.S. Food and Drug Administration (FDA) has added a new boxed warning to the prescribing information for glatiramer acetate, an approved injection therapy for relapsing forms of multiple sclerosis (MS) that’s sold under the brand name Copaxone and is also available as generic products.
A boxed warning is the highest safety-related warning the FDA can assign to a medication. It’s intended to alert healthcare providers and patients about the increased risk of certain serious side effects.
The new warning notes that, in rare cases, glatiramer acetate can cause a a serious allergic reaction called anaphylaxis. This can occur at any point during treatment — after the first injection, or after months or years on the medication. In some cases, the anaphylaxis has led to hospitalization and death.
Symptoms of anaphylaxis can include trouble breathing, swelling of the face or throat, and hives. These can progress to more serious symptoms like severe rash and shock. The FDA is recommending patients and providers be educated about the risks of anaphylaxis and instructed on how to identify warning signs that should prompt immediate medical attention.
Patients who’ve had anaphylaxis related to glatiramer acetate have usually seen the allergic reaction became apparent within an hour after injecting the drug.
What should patients do if they have an allergic reaction?
Glatiramer acetate was first approved under the brand name Copaxone in 1996, but generic versions such as Glatopa and glatiramer acetate injection are also widely available. The medication is given via injections subcutaneously, under the skin, that can be self-administered by patients at home.
The FDA noted the symptoms of anaphylaxis can be similar to immediate post-injection reactions, which usually appear shortly after the injection and then resolve on their own within 15-30 minutes. But anaphylaxis tends to get worse over time and the symptoms are usually much more severe.
Patients who have any reaction after injecting glatiramer acetate should contact their healthcare provider as soon as possible and should wait to take additional injections until told to do so. If symptoms indicative of anaphylaxis are getting worse and aren’t going away, the FDA advises patients to seek immediate emergency medical treatment. The therapy shouldn’t be restarted in patients who have anaphylaxis related to glatiramer acetate.
The decision to add the new warning comes after the FDA identified 82 cases worldwide of d anaphylaxis related to glatiramer acetate, with most cases occurring within one hour of taking the medication. In 19 cases, patients had been taking the medication for more than a year before having a reaction.
Glatiramer acetate is commonly used, so the available data suggest that anaphylaxis related to the medication is very rare. Still, because some patients had severe outcomes that included death, the FDA judged it necessary to add the new warning.
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