News Category: Regulatory news
The HPRA is aware of recent reports which question whether some anti-inflammatory and anti-hypertensive medicines could worsen coronavirus disease (COVID-19). It is important for members of the public to seek advice on their medicines from official sources. Within the EU medicines regulatory network, evidence on the safe use of medicines is reviewed as it emerges and any new advice that arises is disseminated appropriately, including to the public.
In relation to prescription medicines, patients should not stop taking these on foot of media reports, which may be unsubstantiated, and should instead seek the advice of their doctor should they have concerns. The advice of pharmacists should be followed regarding use of over the counter medicines. Patients should always read the package leaflet for information on how to use their medicines correctly. The latest package leaflet for individual medicines is available on the HPRA website.
In light of recent media reports, the HPRA has issued the following guidance. The HPRA will continue to monitor this issue and will update this web page as necessary.
Anti-inflammatory medicines
Paracetamol and ibuprofen (a non-steroidal anti-inflammatory drug, NSAID) are commonly used for symptomatic treatment of pain and fever.
There is no change to the regulatory advice for use of ibuprofen in approved indications and recent reports in the media are unverified. Regarding infection, the anti-inflammatory effects of ibuprofen may mask the signs and symptoms of infection and current advice is to use these medicines at the lowest effective dose for the shortest possible period. Patients should consult a doctor if symptoms persist or worsen. Furthermore, the European Medicines Agency (EMA) safety committee is assessing all available evidence of a link between ibuprofen and worsening infection in general, and advice will be updated if necessary. This review is not specific to worsening of COVID-19 infection, for which currently there is no scientific evidence supporting a link to ibuprofen.
Regarding paracetamol, dosage instructions as described in the package leaflet should be strictly adhered to. The public are also reminded of existing warnings on the risk of overdose.
Anti-hypertensive medicines
ACE inhibitors and Angiotension II Receptor Blockers (ARBs) are antihypertensive medicines commonly used to lower blood pressure. Recent scientific articles have suggested possible links between these medicines and COVID-19 outcomes. These links are theoretical in nature, with some suggesting a risk of complication and others a protective effect for these medicines. There is currently no scientific evidence to support either claim, and patients should not stop taking their medicines on foot of these reports. The EMA’s safety committee will continue to monitor this matter, and advice will be updated if necessary.
Advice from the European Medicines Agency (EMA)
Subsequent to the above information being published by the HPRA, the EMA also published advice on the use of non-steroidal anti-inflammatories for COVID-19 on 18 March 2020. Additionally, on 27 March, and again on 9 June, it recommended the continued use of medicines for hypertension, heart or kidney disease during the COVID-19 pandemic.
Further information
The HSE has also published advice on this matter for members of the public on its website. Any questions or concerns regarding any medicine you are taking should be discussed with your doctor and/or pharmacist. For the latest COVID-19 (coronavirus) health information, advice and guidelines, visit hse.ie and gov.ie/health-covid-19.
Patients should always read the package leaflet for information on how to use their medicines correctly. The latest package leaflet for individual medicines is available on the HPRA website.
Any changes to the regulatory position on this matter will be published on the HPRA website. Healthcare professionals should refer to the HSE website for up-to-date clinical guidelines.