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risk-analysis

Ibuprofen can be safely taken to treat the symptoms of COVID-19, the UK’s Medicines and Healthcare products Regulatory Agency has concluded.

A drug safety review conducted by MHRA advisory body the Commission on Human Medicines found that there was “currently insufficient evidence” to establish a link between the use of ibuprofen, or other nonsteroidal anti-inflammatory drugs (NSAIDs), and contracting or worsening of COVID-19.

In a statement endorsed by the National Health Service and the National Institute for Health and Care Excellence, the MHRA said sufferers of the coronavirus could self-medicate with either ibuprofen or paracetamol to control symptoms such as fever or headache.

“The lowest effective dose of ibuprofen should be used for the shortest duration necessary to control symptoms,” is the official advice.

Prior to this review, the official advice of the NHS has been to avoid ibuprofen and instead take paracetamol when experiencing COVID-19 symptoms. Indeed, at time of writing on 15 April the NHS is yet to update its website with the new guidance on ibuprofen.

Separately, healthcare professionals have been advised by the regulator to consider a patient’s individual risk factors, including any history of cardiovascular and gastrointestinal illness, when prescribing ibuprofen.

Those who have been prescribed NSAIDs as a treatment for a long-term condition, such as arthritis, should keep taking these drugs as normal, MHRA states.

Warning from France

The Commission on Human Medicines conducted its review of ibuprofen at the request of NHS England, following claims from France that NSAIDs could aggravate a COVID-19 infection.

The French warning led the European Medicines Agency on March 18 to insists there was “currently no scientific evidence establishing a link between ibuprofen and worsening of COVID‑19.” (Also see "EMA Quashes Claims That Ibuprofen Worsens Infection From Coronavirus" - HBW Insight, 18 Mar, 2020.)

“EMA is monitoring the situation closely and will review any new information that becomes available on this issue in the context of the pandemic,” it added.

EMA Review Of NSAIDs Ongoing

Safety concerns related to ibuprofen and another NSAID, Ketoprofen, were already on the radar of the EMA prior to the coronavirus outbreak.

In May last year, EMA started a review of ibuprofen and ketoprofen following a survey by the French National Agency for Medicines and Health Products Safety (ANSM) which suggested that some bacterial infections could be made worse by these drugs. (Also see "France Warns Of Serious Complications Related To OTC Ibuprofen Use" - HBW Insight, 25 Apr, 2019.)

EMA’s Pharmacovigilance Risk Assessment Committee is continuing to review all available data to see if any safety measures are required, with the issue on the agenda for discussion at its 14-17 April 2020 meeting.

According to the agenda, the PRAC intends to adopt an official recommendation based on the “signal of serious exacerbation of infections” related to the NSAIDs, in single and fixed-dose combinations with other active ingredients.

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