The European Medicines Agency (EMA) has information from social media raising concerns that non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, may worsen the course of coronavirus disease (COVID-19) .
There is currently no scientific evidence establishing a link between ibuprofen and worsening of COVID-19. The EMA is closely monitoring the situation and will consider any new information that becomes available on this issue in the context of the pandemic.
In May 2019, the EMA Pharmacovigilance Risk Assessment Committee (PRAC) started a review of the nonsteroidal anti-inflammatory drugs (NSAIDs) ibuprofen and ketoprofen following a survey by the French National Agency for the Safety of Medicines and Health Products (ANSM), which suggested that the course of chickenpox and certain bacterial infections may worsen with the use of these medicinal products. The information in the package leaflets of many NSAIDs already contains a warning that their anti-inflammatory action may mask the symptoms of a worsening infection. PRAC is reviewing all available data to see whether an additional safety measure is needed.
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 medicinal product has its own benefits and risks, which are reflected in its instructions for medical use and should be considered together with national treatment recommendations, most of which recommend paracetamol as the first-line option for treating fever or pain.
In accordance with national EU treatment recommendations, patients and healthcare professionals may continue to use NSAIDs (for example, ibuprofen) in accordance with the approved information in the summary of product characteristics. The recommendations provide that these medicinal products be used at the lowest effective dose for the shortest possible period.
Patients who have any questions should contact their doctor or pharmacist. At present, there is no reason for patients taking ibuprofen to interrupt treatment on the basis of the above. This is especially important for patients taking ibuprofen or other NSAID medicines for chronic conditions.
In addition to the ongoing PRAC safety review of ibuprofen and ketoprofen, the EMA emphasizes the need for timely epidemiological studies to provide adequate evidence on any effect of NSAIDs on the prognosis of COVID-19. The Agency is reaching out to its stakeholders and is ready to actively support such studies, which may be useful for guiding any future treatment recommendations.
EMA will provide additional information if necessary, and after the PRAC review is completed
More about medicines
Most medicinal products containing ibuprofen are authorized nationally in the EU as an analgesic, and in some countries also as an antipyretic (fever medicine). They are widely available without a prescription and by prescription. Oral ibuprofen (over-the-counter or prescription) is used, depending on the indication, in adults, children and infants aged three months and older for the short-term treatment of fever and/or pain, such as headache, influenza, toothache and dysmenorrhea. Ibuprofen is also prescribed for the treatment of arthritis and rheumatic conditions. Ketoprofen is a similar medicine, mainly prescribed for various painful and inflammatory conditions, although in some Member States it is available without a prescription.
Ibuprofen has also been authorized centrally as the product Pedea for the treatment of “patent ductus arteriosus” in premature newborns.
More about the procedure
The review of ibuprofen and ketoprofen is being conducted in the context of a safety signal procedure. A safety signal is new information about the safety of a medicinal product that requires further investigation.
