Health Canada warns of severe allergy risk with some MS products
Warning follows 14 cases of anaphylaxis tied to use of glatiramer acetate
Health Canada is warning that glatiramer acetate products, used in the country to treat relapsing-remitting multiple sclerosis (MS), may cause a severe allergic reaction called anaphylaxis, which can be life-threatening.
The warning follows 11 reported cases of anaphylactic reactions linked to Copaxone — the original brand name of glatiramer acetate — and three reactions from other glatiramer acetate products.
That’s according to an agency press release, stating “Issue: Health products — Product safety, new safety information,” which has this warning:
“If you experience anaphylactic reaction symptoms, stop taking glatiramer acetate and seek immediate medical help by calling 9-1-1. … Do not restart taking glatiramer acetate unless your healthcare provider has identified another clear cause for the anaphylaxis.”
The Canadian prescribing information for Copaxone has already been updated to reflect this new safety risk, and Health Canada is working with other manufacturers, including the makers of Glatect and Mylan glatiramer acetate injection, to update their respective labels, per the agency.
Patients using glatiramer acetate who develop symptoms such as difficulty breathing, swelling of the face or throat, dizziness, or a rapid drop in blood pressure should seek emergency medical care immediately, according to Health Canada.
These reactions can occur at any point during treatment, from as soon as patients receive the first dose to after months or years on the medication. Symptoms generally appear within one hour of injection.
While no fatal cases of anaphylaxis have been reported in Canada, some patients required treatment with epinephrine and other medical interventions, per the agency. Epinephrine injection, commonly known as an EpiPen, is the first-line, emergency treatment for severe allergic reactions.
The regulatory agency has already informed healthcare providers, including neurologists, emergency room physicians and staff, nurses, and pharmacists, about these safety risks.
Glatiramer acetate sold as Copaxone, in other products for MS
Healthcare providers are advised to inform patients about the symptoms of anaphylactic reactions and note that symptoms can be similar to immediate post-injection reactions. Such reactions may occur shortly after injection and spontaneously resolve within 15 to 30 minutes. Anaphylaxis symptoms, however, are typically more severe and worsen over time.
Patients should also be instructed to seek immediate medical care if they experience symptoms of anaphylaxis, and to discontinue treatment if an anaphylactic reaction occurs. The therapy shouldn’t be restarted if the reaction is confirmed to be related to glatiramer acetate.
This safety information was prepared by Health Canada in collaboration with Teva Canada Innovation, Copaxone’s developer, and is being communicated to healthcare providers and Canadians via the Recalls and Safety Alerts Database. It will also be distributed through an email notification system.
In a section titled “What healthcare professionals should do,” the public advisory says clinicians should “inform patients and/or caregivers of the signs and symptoms of anaphylactic reactions, which may overlap with those of an immediate post-injection reaction.”
New boxed warning of allergy risk also added to US product labels
In the U.S., glatiramer acetate products — including Copaxone — are approved for relapsing forms of MS: clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS.
Earlier this year, the U.S. Food and Drug Administration also added a new boxed warning to the labels of glatiramer acetate products after identifying 82 cases worldwide of anaphylaxis related to the medication.
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