The EMA's Pharmacovigilance Risk Assessment Committee (PRAC) has advised healthcare professionals to carefully monitor patients with existing infection who are taking ibuprofen or ketoprofen to relieve pain or fever.
The PRAC made its recommendations following a review of the safety of ibuprofen and ketoprofen. The review started in May 2019, after the French National Agency for Medicines and Health Products Safety (ANSM) published results from a survey which suggested that infection due to chickenpox and some bacterial infections including pneumonia could be made worse by these medicines.
The product information for some NSAIDs already includes a warning about their potential to mask symptoms of infection, but the MHRA has said that the product information for ibuprofen and ketoprofen will be updated so that all NSAIDs available for prescribing in the UK have consistent warnings. The MHRA has advised that licensed indications of ibuprofen, including the treatment of possible symptoms of infection such as fever, will remain unchanged.
The PRAC's recommendations come in the wake of concerns about the use of ibuprofen for the treatment of COVID-19 symptoms. On 15th April, the Commission on Human Medicines (an advisory body of the MHRA) concluded that there is insufficient evidence to establish a link between use of ibuprofen, or other NSAIDs, and contracting or worsening of COVID-19. The CHM said that patients can take ibuprofen when self-medicating for symptoms of COVID-19.
The use of ibuprofen in patients with COVID-19 was not assessed in the EMA's review since no data were available. However, the EMA is monitoring the situation closely and reviewing new information as it becomes available.
When starting treatment for COVID-19 symptoms such as fever and pain, the EMA says patients and healthcare professionals should consider all available treatment options including paracetamol and NSAIDs. They can continue using NSAIDs as indicated in the approved product information and are reminded that these medicines should be used at the lowest effective dose for the shortest possible period.