HPRA acts on Mayo coroner's recommendation to monitor MS drug

The Health Products Regulatory Authority has informed the Coroner of Mayo that it is updating product information of a medication used to treat multiple sclerosis that may cause an anaphylactic reaction.

The updating of the product information follows an EU-wide review of Glatiramer Acetate, a medication used to treat multiple sclerosis which found that it is associated with anaphylactic reactions.

Elaine Quinn, a mother of two, from Crillaune, Ross, Castlebar died in Mayo University Hospital on February 12, 2022, three days after administering herself with her regular medication Glatiramer Acetate, known by its brand name Copaxone.

The inquest into Mrs Quinn’s death heard that the 42 year old had an anaphylactic reaction to the medication which was administered at her home and suffered cardiac arrest.

At the conclusion of the inquest in June, Mr Pat O’Conner, the coroner for Mayo, recommended to the HPRA to continue its investigations into any possible side effects of the drug 'Copaxone' and inform the public and medical profession of its findings.

On August 14, the HPRA informed Mr O’Connor that an EU-wide review of glatiramer acetate found that anaphylactic reactions may occur shortly following the administration of the medicine and in some cases a fatal outcome has been reported.

As a result of the review, the product information of all glatiramer acetate-containing medicines has been updated by the HPRA and circulated to consultants and GPs around the country.

Anne Tobin, Pharmacovigilance Manager with HPRA stated that a EU-wide review of all available data concerning anaphylactic reactions with glatiramer acetate has concluded that the medicine is associated with anaphylactic reactions, which may occur shortly following administration of glatiramer acetate even months up to years after initiation of treatment.

Ms Tobin explained that as a result of the findings new measures will be taken and a Direct Healthcare Professional Communication (DHPC) highlighting this important safety information, is being circulated in Ireland to relevant healthcare professionals including consultant neurologists, emergency department consultants, retail pharmacies and GP practices.

The updated product information states that patients receiving treatment with glatiramer acetate and their caregivers should be informed about the signs and symptoms of anaphylactic reactions and instructed to seek immediate emergency medical care if an anaphylactic reaction occurs.

“This is particularly important given the seriousness of anaphylactic reactions and the possibility for self-administration in the home settings.

“The product for all glatiramer acetate-containing medicines will be updates with new information regarding the risk of anaphylactic reactions, including anaphylactic reactions occurring months up to years after initiation of treatment , and the new measures to be taken,” the communication to healthcare professionals states.

Mrs Quinn was found unresponsive in her home on the morning of February 9, 2022 and rushed to Mayo University Hospital where tests showed features of an anoxic brain injury. Ms Quinn failed to respond to treatment and she passed away peacefully on February 12.

The post mortem into her death found she died as a result of acute fatal cerebral ischaemia due to anaphylactic shock.

The inquest into her death heard that it is possible that her medication 'triggered an anaphylactic reaction' which led to a 'catastrophic brain injury'.

At the conclusion of the inquest in Swinford Courthouse in June, Declan Hynes, the solicitor for Mrs Quinn's husband Paul and her family said the family had used medical experts to conduct their own investigation into her death. He said that they accepted and understood the findings of her death but had concerns regarding Glatiramer Acetate and there should be ongoing vigilance of it.

“Family were adamant that there would be ongoing vigilance of this product,” he said. “They have heard and accept the evidence they feel there is something of an unknown and a lacuna there for them. They feel the medication prescribed is what ultimately led to Elaine's passing albeit medical evidence there is no known background case which has led to a fatality.”

In recording an open verdict into the death of Mrs Quinn, Mr O'Connor said that while an anaphylactic reaction triggered by taking this medication is extraordinarily unusual, it did unfortunately occur in Mrs Quinn's case and he hopes it will be taken into account by clinicians in the future.

“I think it is appropriate that I should recommend that the HPRA continues its vigilance into this particular medication and they continue to monitor as they will under their statutory obligations I am sure the clinicians who are here will echo that recommendation,” Mr O' Connor said.