EMA: No Evidence NSAIDs Unsafe With Coronavirus Amid Confusion

Regulatory NewsRegulatory News | 18 March 2020 |  By 

Credit: NIAID-Rocky Mountain Laboratories

Editor's note: This article has been updated to include clarification from the World Health Organization (WHO) and comments from the US Food and Drug Administration (FDA).

Following media reports that non-steroidal anti-inflammatory medicines (NSAIDs), including ibuprofen, could be harmful to patients with coronavirus disease (COVID-19), the European Medicines Agency (EMA) on Wednesday clarified that there is currently no evidence to support those claims.
The advisory comes after French Health Minister Olivier Veran warned on Saturday that anti-inflammatory drugs, including ibuprofen and cortisone, could worsen COVID-19 infections, and instead instructed those with symptoms for the disease to take paracetamol, or acetaminophen as it is referred to in the US.
France’s Directorate General of Health issued recommendations the same day advising against the use of NSAIDs to treat patients with COVID-19, noting that “serious adverse events” had been reported in possible and confirmed COVID-19 cases.
Veran’s claims were echoed on Monday by World Health Organization (WHO) Spokesperson Christian Lindmeier, who told reporters that WHO was looking into the matter and advised patients not self-medicate with ibuprofen. On Thursday, Wednesday, WHO clarified that based on currently available information it does not advise against taking ibuprofen.

The US Food and Drug Administration (FDA) also issued a statement addressing the use of NSAIDs for patietns with COVID-19. FDA says it "is not aware of scientific evidence connecting the use of NSAIDs, like ibuprofen, with worsening COVID-19 symptoms," and that it is investigating the issue.
While EMA says its Pharmaceutical Risk Assessment Committee (PRAC) will review the available evidence, it does not advise patients to stop taking ibuprofen. EMA also says that patients and physicians should “consider all available treatment options including paracetamol and NSAIDs,” for treating fever or pain associated with COVID-19 while considering national treatment guidelines, “most of which recommend paracetamol as a first treatment option.”
The agency notes that PRAC has been reviewing the safety of two NSAIDs, ibuprofen and ketoprofen, since May, following concerns raised by France’s Agency for Medicines and Health Products Safety (ANSM) that the drugs could worsen chickenpox and certain bacterial infections.
“Further to the ongoing PRAC safety review on ibuprofen and ketoprofen, 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,” EMA writes, adding that it is reaching out to stakeholders to support such studies.
The UK’s National Health Service (NHS) also said there is “no current literature on the impact of NSAIDs use in COVID-19,” and instructed the Medicines and Healthcare products Regulatory Agency and National Institute for Health and Care Excellence to review the available evidence.
However, NSH England Medical Director Stephen Powis advised patients to use paracetamol over NSAIDs until more is known.


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