What you should know about ibuprofen and COVID-19

What you should know about ibuprofen and COVID-19. Get the facts (picture of Advil tabs and GSK logo on orange background)

To Our Medical Professional Community,

As we all struggle through this unprecedented health situation with the novel coronavirus (COVID-19), an unfortunate consequence is for speculation and misinformation to circulate, exacerbating worldwide anxiety. Specifically, without supportive clinical evidence, the use of ibuprofen in patients with COVID-19 has been called into question.

At GSK Consumer Healthcare, we understand your need to have the correct information to feel confident in your treatment decisions, and address your patients’ questions and concerns. As your trusted partner in the healthcare and well-being of your patients, we are committed to supporting you.

Here are the facts:

An article recently published in The Lancet Respiratory Medicine hypothesized a connection between ibuprofen and worsening symptoms of COVID-19. The authors cited studies showing that the expression of ACE2 was substantially increased in patients treated with angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs). They also implicated ibuprofen and thiazolidinediones in the upregulation of ACE2.1

This theory regarding the use of nonsteroidal anti-inflammatory drugs (NSAIDs)—specifically, ibuprofen worsening COVID-19 symptoms is without clinical evidence and has caused considerable confusion and controversy within the medical community. 

As a leader in the OTC pain category, we would like to address this speculation. To be clear, there is no scientific evidence that directly links the use of ibuprofen or other anti-inflammatories with worsened outcomes in patients suffering from COVID-19 infection.

This is an emerging and rapidly evolving situation, and because consumer safety is our foremost priority, we are closely monitoring independent statements from respected public health authorities and medical experts.

“At this time, FDA is not aware of scientific evidence connecting the use of NSAIDs, like ibuprofen, with worsening COVID-19 symptoms. The agency is investigating this issue further and will communicate publicly when more information is available."2

“Based on currently available information, WHO does not recommend against the use of ibuprofen. We are also consulting with physicians treating COVID-19 patients and are not aware of reports of any negative effects of ibuprofen, beyond the usual known side effects that limit its use in certain populations. WHO is not aware of published clinical or population-based data on this topic."3

Anthony Fauci, MD, NIAID Director: “There’s not enough data. What happens is sometimes off-the-cuff discussions turn into letters, then turn into social media…Bottom line, I have not seen any firm data to indicate there’s a problem or to prove that there’s not a problem."4

A legacy of evidence-based safety5

Ibuprofen is a well-established medicine that safely and effectively reduces fevers and provides pain relief when used as directed.

  • It has been used by millions of consumers across 40 markets for more than 3 decades
  • It has been extensively studied and is strictly regulated to ensure its use complies with local healthcare authority requirements
  • Safety is supported by over 30 years of monitoring and post market surveillance reporting AEs to the FDA
  • It has been extensively used to relieve some of the symptoms of influenza (pain and fever)

Moving forward in these times

Consistent with the current recommendations of the major public health organizations, GSK Healthcare recommends that you speak directly with your patients regarding their individual treatment needs.

In addition, without a scientifically based consensus within the medical community or a proven mechanistic rationale, we hope that you continue to feel confident about using ibuprofen appropriately as a fever and pain reducer to provide comfort and care for your patients with COVID-19.

We will continue to monitor the situation and provide you with updates as they come in. As always, we remain committed to providing balanced information about our medicines, maintaining transparency about our work, operating with integrity, and always putting the interests of patients first.

Thank you and stay safe.

  • Yes, according major regulatory bodies, there is no evidence to the contrary. Ibuprofen is a well-established medicine that safely and effectively reduces fevers and provides pain relief when used as directed.5

    • It has been used by millions of consumers across 40 markets for more than 3 decades
    • It has been extensively studied and is strictly regulated to ensure its use complies with local healthcare authority requirements
    • Safety is supported by over 30 years of monitoring and post market surveillance reporting AEs to the FDA
    • It has been extensively used to reduce pain and fever in influenza, as well as other viral and bacterial infections
  • The initial speculative concern came from a study by Wan et al in the Journal of Virology involving hypertensive patients taking an angiotensin-converting enzyme (ACE) inhibitor.6 The French Health Minister then cited it in a tweet, and the misinformation spread. Additionally, an article recently published in The Lancet Respiratory Medicine hypothesized a connection between ibuprofen and worsening symptoms of COVID-19.1 The authors cited studies showing that the expression of ACE2 was substantially increased in patients treated with ACE inhibitors and angiotensin II receptor blockers (ARBs). They also implicated ibuprofen and thiazolidinediones in the upregulation of ACE2.

    This theory regarding the use of nonsteroidal anti-inflammatory drugs (NSAIDs)—specifically ibuprofen—worsening COVID-19 symptoms, is without conclusive clinical evidence, and has caused considerable confusion and controversy within the medical community.

    • In a recent correspondence to The Lancet Respiratory Medicine, Fang et al cite 3 different studies to suggest that the most distinctive comorbidities each had in common was cardiovascular disease1
      • The first study showed that 32 nonsurvivors from a group of 52 intensive care unit patients with COVID-19 had cerebrovascular diseases (22%) and diabetes (22%)
      • The second study demonstrated that 173 of the 1099 patients with confirmed COVID-19 had hypertension (23.7%), diabetes mellitus (16.2%), coronary heart disease (5.8%), and cerebrovascular disease (2.3%)
      • Finally, the last study showed that of 140 patients hospitalized with COVID-19, 30% had hypertension and 12% had diabetes
    • The authors hypothesize that these frequent comorbidities are likely treated with ACE inhibitors; however, treatment paradigms were not addressed in the above studies
  • An article recently published in The Lancet Respiratory Medicine hypothesized a connection between ibuprofen and worsening symptoms of COVID-19.1 The authors cited studies showing that the expression of ACE2 was substantially increased in patients treated with ACE inhibitors and ARBs. They also implicated ibuprofen and thiazolidinediones in the upregulation of ACE2.

    The authors also propose the following: “A further aspect that should be investigated is the genetic predisposition for an increased risk of SARS-CoV-2 infection, which might be due to ACE2 polymorphisms that have been linked to diabetes mellitus, cerebral stroke, and hypertension, specifically in Asian populations.”

    Fang et al referenced a study by Wan et al (Journal of Virology. 2020; published online January 29. doi:10.1128/JVI.00127-20) that illustrates human pathogenic coronaviruses (severe acute respiratory syndrome coronavirus [SARS-CoV] and SARS-CoV-2) bind to target cells via ACE2, which is expressed by epithelial cells of the lung, intestine, kidney, and blood vessels.6

    • It also shows that the expression of ACE2 is substantially increased in patients with type 1 or type 2 diabetes, who are treated with ACE inhibitors and ARBs
    • Finally, Yang et al reference the data from Li et al (Pharmacology Research 2017;125(Pt A):21-38) in which they conclude that hypertension is also treated with ACE inhibitors and ARBs, which upregulate ACE2. They also stated that ibuprofen and thiazolidinediones can increase ACE27

    Fang et al conclude that the upregulation of ACE2 would facilitate infection with COVID-19. They hypothesize that treatment of diabetes and hypertension with ACE2-stimulating drugs increases the risk of developing severe and fatal COVID-19, and that patients with cardiac diseases, hypertension, or diabetes who are treated with ACE2-increasing drugs are at higher risk for severe COVID-19 infection.

    This theory regarding the use of NSAIDs—specifically, ibuprofen—worsening COVID-19 symptoms is without clinical evidence and has caused considerable confusion and controversy within the medical community.

  • FDA: “At this time, FDA is not aware of scientific evidence connecting the use of NSAIDs, like ibuprofen, with worsening COVID-19 symptoms. The agency is investigating this issue further and will communicate publicly when more information is available.2

    https://www.fda.gov/drugs/drug-safety-and-availability/fda-advises-patients-use-non-steroidal-anti-inflammatory-drugs-nsaids-covid-19

  • WHO: “Based on currently available information, WHO does not recommend against the use of ibuprofen. We are also consulting with physicians treating COVID-19 patients and are not aware of reports of any negative effects of ibuprofen, beyond the usual known side effects that limit its use in certain populations. WHO is not aware of published clinical or population-based data on this topic.”3

  • Anthony Fauci, MD, Director, NIAID, says: “There’s not enough data. What happens is sometimes off-the-cuff discussions turn into letters, then turn into social media…Bottom line, I have not seen any firm data to indicate there’s a problem or to prove that there’s not a problem.”4

  • As we continue to closely monitor COVID-19 and Advil use, we will continue to be transparent in our communications, and committed to the health and safety of our customers.

    Consistent with the current recommendations of the major public health organizations, GSK Consumer Healthcare recommends that you speak directly with your patients regarding their individual treatment needs.

    In addition, without a scientifically based consensus within the medical community or a proven mechanistic rationale, we ask that you continue to recommend ibuprofen.

  • Visit AdvilAide.com to learn more about Advil and its established safety profile.

  • You and your patients can visit Advil.com/coronavirus for important resources about COVID-19 and ibuprofen use.

Register now

Sign up

For news, updates, and more, click the link below to sign up and be on our mailing list

Register Now