EMA issues statement on ibuprofen reports relating to COVID-19
Posted: 19 March 2020 | Victoria Rees (European Pharmaceutical Review) | No comments yet
The EMA has announced that reports of NSAIDs like ibuprofen making the COVID-19 coronavirus worse have no scientific basis.
The European Medicines Agency (EMA) has issued a statement on false reports about the effect of non-steroidal anti-inflammatory medicines (NSAIDs) such as ibuprofen on the COVID-19 coronavirus.
The agency says it is aware of reports, particularly on social media, which raise questions about whether NSAIDs worsen the virus.
According to the organisation, there is currently no scientific evidence establishing a link between ibuprofen and worsening of COVID‑19. The EMA says it is monitoring the situation closely and will review any new information that becomes available on this issue in the context of the pandemic.
In May 2019, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) started a review of the NSAID medicines ibuprofen and ketoprofen following a survey by the French National Agency for Medicines and Health Products Safety (ANSM) which suggested that infection due to chickenpox (varicella) and some bacterial infections could be made worse by these medicines. The product information of many NSAIDs already contains warnings that their anti-inflammatory effects may hide the symptoms of a worsening infection. The PRAC is reviewing all available data to see if any additional measure is required.
The EMA says that when starting treatment for fever or pain in COVID-19, patients and healthcare professionals should consider all available treatment options including paracetamol and NSAIDs. Each medicine has its own benefits and risks which are reflected in its product information and which should be considered along with EU national treatment guidelines, most of which recommend paracetamol as a first treatment option for fever or pain.
In line with EU national treatment guidelines, patients and healthcare professionals can continue using NSAIDs such as ibuprofen as per the approved product information. Current advice includes that these medicines are used at the lowest effective dose for the shortest possible period.
Further to the ongoing PRAC safety review on ibuprofen and ketoprofen, the EMA highlights the need for epidemiological studies to be conducted in a timely manner to provide adequate evidence on any effect of NSAIDs on disease prognosis for COVID-19. The agency is ready to actively support such studies, which could be useful in guiding any future treatment recommendations.
Active Pharmaceutical Ingredient (API), Drug Safety, Industry Insight, QA/QC, Toxicology, Viruses
EMA Pharmacovigilance Risk Assessment Committee (PRAC), European Medicines Agency (EMA)