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10,918 reported adverse reactions to medicine in 2022
HPRA director of enforcement Grainne Power Pic: Courtesy HPRA

01 May 2024 / regulation Print

10,918 reported adverse reactions to medicines

Some 956,263 dosage units of falsified and other illegal medicines were seized in 2022, the Health Products Regulatory Authority (HPRA) has stated.

Products detained included sedatives, erectile-dysfunction medicines, analgesics, and anabolic steroids.

Body image

The HPRA annual report warns of the risk to consumers in sourcing falsified medicines and unauthorised substances for “aesthetic and body-image” purposes.

The annual report details a total of 10,918 suspected cases of adverse reaction to human medicine.

This is a decrease on the number received in 2021 and during the initial mass immunisation campaigns against COVID-19.

Of the reports received in 2022, 2,852 were associated with the use of COVID-19 vaccines.

Of the reports received in 2022, 21.5% were submitted by the public, 9% by healthcare professionals, and 69% were reported by marketing authorisation holders.

Medicines subject to additional monitoring accounted for 32% of the reports submitted, of which 26% were related to COVID-19 vaccines.

A total of 529 new human medicines were authorised during 2022 while 199 medical-device economic operators were registered with the HPRA.

'Concerning' trend

The HPRA cites a “concerning” upward trend in detentions of Melanotan 2, an unregulated self-tanning aid, as well as botulinum toxin (botox) and online semaglutide and liraglutide glucose products.

The regulator warned that consumers have no guarantees as to safety, quality or effectiveness outside of the regulated supply chain.

In 2023, 14 voluntary formal cautions were issued, while 874,945 dosage units of falsified and other illegal medicines were detected, a slight drop on the previous year’s figure.

However, there was a more than 20% increase in the volume of illegal anabolic steroids detained in 2023.


HPRA director of enforcement Grainne Power said: “We believe young men in particular may be sourcing anabolic steroids for body enhancement, while being unaware of the serious health complications posed by these products.

“Anabolic steroids can cause serious physical and psychological health issues.

“The potential physical side effects alone include heart failure, liver issues, kidney damage, and infertility,” she said.

The HPRA works with the Director of Public Prosecutions in relation to the illegal supply of medicines, with two prosecution cases initiated relating to the importation or distribution of anabolic steroids.

And 2,348 websites, e-commerce listings, and social media pages were amended or shut down in 2023.

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