Family of Castlebar woman call for more vigilance into MS drug

The family of a 40-year-old mother of two have called for more vigilance regarding the side effects of a drug used to manage Multiple Sclerosis, which they believe contributed to her death.

Elaine Quinn, a mother of two, from Crillaune, Ross, Castlebar died in Mayo University Hospital on February 12, 2022 after she suffered cardiac arrest shortly after administering herself with her regular medication Glatiramer Acetate, known by its brand name Copaxone, used to manage her Multiple Sclerosis (MS).

She was found unresponsive in her home on the morning of February 9 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 concluded in Swinford Courthouse yesterday (Monday) and heard that it is possible that her medication 'triggered an anaphylactic reaction' which led to a 'catastrophic brain injury'.

Glatiramer Acetate has been commonly used in the management of MS for more than 20 years and the inquest heard it is 'regarded as an extremely safe form of MS immunomodulatory treatment' with no significant side effects.

Concerns

However, Declan Hynes, the solicitor for Mrs Quinn's husband Paul and her family said that while they accepted and understood the findings of her death they still have concerns regarding Glatiramer Acetate.

“The family were adamant that there would be ongoing vigilance of this product,” he said. “They have heard and accept the evidence [but] 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 shows there are no known background cases which have led to a [similar] fatality.”

Dr Michael Hennessy, Consultant Neurologist, who treated Mrs Quinn's condition, informed the Coroner Pat O'Connor that such a reaction as suffered by Mrs Quinn must be considered to be extremely rare.

“I can certainly find no prior examples of anaphylaxis causing death in a patient in this form of treatment,” he wrote in correspondence to Mr O'Connor.

Mr O'Connor informed the inquest that he wrote to the Health Protection Regulatory Authority seeking information on the drugs and whether there was any history to recorded reactions to Glatiramer Acetate in Ireland.

In a response to Mr O'Connor's queries, Anne Tobin, Pharmacovigilance Manager with the HPRA, explained that they were notified of 14 reports of suspected anaphylactic reactions but the majority of the patients did not require hospital treatment and no other cases are known to have resulted in a fatal outcome.

Ms Tobin also confirmed that Dr Tomas Nemeth, Consultant Pathologist who performed Ms Quinn's post mortem, has submitted a 'suspected adverse reaction report' to the HPRA and this information is being fully considered as part of ongoing safety monitoring for Glatiramer Acetate in Ireland and at EU level.

“The regulatory procedure through which the assessment is being undertaken has not yet concluded and is expected to be finalised in the coming months. It is possible that an update to the approved product information may be recommended,” she wrote in correspondence to Mr O'Connor.

Unnatural causes

Dr Nemeth told the inquest that it was his opinion that the death of Mrs Quinn was due to unnatural causes as medication should be safe and not cause death. He accepted that there are cases of people dying after taking prescribed medication which is regarded as safe and it was his opinion Mrs Quinn's death was unnatural.

Mr Fiarchra Breathnach, counsel for staff at Mayo University Hospital asked Mr O'Connor to consider recording a narrative verdict or an open verdict into the death of Mrs Quinn.

In recording his verdict, Mr O'Connor said that he hopes that the HPRA learns from the death of Mrs Quinn and there will be some benefit to the public in the future from these learnings. He said it won't allay the grief suffered from Mrs Quinn's family but they may take some comfort from lessons learned into her death.

Mr O'Connor recorded an open verdict into Mrs Quinn's death as the most appropriate finding.

“The reality is there are no other fatalities of this nature which were brought to my attention by the extensive research so it is appropriate that an open verdict be recorded,” he said.

Mr O’Connor added 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. He said he is recommending that the HPRA continues to monitor the drug into 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,” he said.

Mr O'Connor expressed his sympathies to Mrs Quinn's husband, Paul and her two children, Seán and Amy and her mother Maureen and siblings on their untimely death in unfortunate circumstances.

Mr Hynes said he also wished to pass on the family's thanks and extreme gratitude to the staff at MUH for the care they gave Elaine in her final hours. They also wished to thank Dr Nemeth for the interest he showed in the case and to Mr O'Connor for the sensitive way he handled the inquest.