Covid-19 vaccines accounted for just five per cent of all adverse reactions to medicines reported in Ireland last year.
New figures published by the Health Products Regulatory Authority show that 400 incidents of people suffering adverse reactions to Covid-19 vaccines were recorded during 2023.
The HPRA said it was a decrease on the heightened number of reports received the previous year when 2,852 such incidents were recorded, accounting for 26% of all reports of side effects to medicines.
Overall, a total of 7,793 adverse reactions incidents across all medicines were reported to the HPRA last year – the second lowest annual total in the past five years and an annual decrease of 29 per cent.
By comparison, almost 18,000 suspected adverse reactions to Covid-19 vaccines were recorded in 2021 which represented approximately 70 per cent of all such incidents that year.
The surge in reports of reactions to various Covid-19 vaccines in 2021 resulted in a trebling of the overall level of adverse reactions compared to 2020.
The HPRA said submission of reports of suspected side effects enables regulators to monitor the safety of vaccines and to take the most appropriate action required should new safety-related information become available.
The latest figures show approximately half of all adverse reaction reports last year related to what are classified as antineoplastic medicines which are used in the treatment of cancer.
They include immune-modulating medicines, monoclonal antibodies and endocrine medications.
Overall, there were 3,954 adverse reaction reports in relation to antineoplastic medicines in 2023.
The second largest category for such reports was vaccines, accounting for 607 of the total, of which 400 related to Covid-19 vaccines.
The other main classification of medicines for which several hundred incidents of adverse reactions were recorded included psycholeptic medicines used for calming patients (527 cases) ; medicines for the treatment of Parkinson’s Disease (497); anti-infective medicines including antibacterials and antivirals (457) and medicines for obstructive airway diseases (268).
The HPRA revealed that 140 patients were reported to have died following treatment with a suspect medicine of which 16 related to vaccines.
However, the regulatory body stressed that the number of reports received cannot be used as a basis for determining the incidence of a reaction as neither the total number of reactions nor the number of patients using the medicine is known.
In relation to Covid-19 vaccines, the HPRA said it “continues to closely monitor reports of suspected side effects received, particularly those that describe a fatal outcome.”
It pointed out that it published summary information about suspected side effects reported in Ireland following Covid-19 vaccination throughout 2023.
The latest figures showed 60 patients died who had suffered an adverse reaction to antineoplastic medicines, while 26 deaths were among patients who had experienced side effects to psycholeptic medicines.
The HPRA also noted: “It can be expected that fatalities due to progression of underlying disease or natural causes will continue to occur during or after treatment with medicines. This does not mean that the medicine caused the death.”
It stated that individual reports alone are rarely sufficient to establish causation and that it is essential that the totality of data about a medicine is examined.
The HPRA pointed out that in many fatalities, the patient concerned was described as having significant underlying illness and were treated with multiple medicines and/or surgery.
In its latest annual report, the HPRA – which was previously known as the Irish Medicines Board – said 84 per cent of adverse reactions reports were filed by the marketing authorisation holders with eight per cent of cases submitted by members of the public and seven per cent by healthcare professionals.
The HPRA said most reports received from marketing authorisation holders would have initially been notified to them by healthcare staff or members of the public.
A total of 1,267 cases of defects in the quality of medical products were recorded last year, of which 332 were classified as “high risk”, while 59 medicines were recalled during 2023.
The HPRA also recorded the seizure of 874,945 doses of falsified or illegal medicines last year – down nine per cent on 2022 levels.
The products detained included sedatives (34 per cent), anabolic steroids (29 per cent), erectile dysfunction medicines (10 per cent) and analgesics (five per cent).
Enforcement activity by HPRA officials also resulted in the amendment or shutdown of 2,348 websites, e-commerce listings or social media pages associated with the sale of falsified or illicit medicinal products last year.
