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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 to 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 is the latest information:

An article published in The Lancet Respiratory Medicine on March 11, 2020 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 and support the medical community in their decision making when it comes to their patients. 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.

For more information refer to the websites for these public health authorities. These organizations are not officially affiliated with Advil and use of their logos does not imply endorsement.

Health Canada

“There is no scientific evidence that establishes a link between ibuprofen, or other non-steroidal anti-inflammatory drugs (NSAIDs), and the worsening of COVID-19 symptoms. The Government of Canada is monitoring the situation closely, including reviewing new information and reports as they become available, and will take the appropriate action to help protect the health and safety of Canadians.2  When choosing a fever or pain relief medication for COVID-19, patients and healthcare professionals should consider all available treatment options, including acetaminophen and NSAIDs.2,3

World Health Organization (WHO)

Based on currently available information, World Health Organization (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.”4

A rapid systematic review was carried out by the World Health Organization (WHO) on 20 March 2020 with the aim to assess the effects of prior and current use of NSAIDs in patients with acute viral respiratory infections on acute severe adverse events, acute health care utilization, as well as on quality of life and long-term survival. The review included studies conducted in humans of any age with viral respiratory infections exposed to systemic NSAIDs of any kind. All studies on COVID-19, the Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS) were included irrespective of their sample size. The review concluded that at present there is no evidence of severe adverse events, acute health care utilization, long-term survival, or quality of life in patients with COVID-19, as result of the use of NSAIDs. A Scientific Brief was published on 19 April 2020 detailing the Methods, Results, and Limitations of the systematic review5.

National Institute of Allergy and Infectious Diseases (NIH)

The National Institute of Allergy and Infectious Diseases (NIH) COVID-19 Treatment Guidelines recommend the following for the use of NSAIDs in patients with COVID-196:

  • Persons with COVID-19 who are taking NSAIDs for a co-morbid condition should continue therapy as previously directed by their physician (AIII).
  • The Panel recommends that there be no difference in the use of antipyretic strategies (e.g. with acetaminophen or NSAIDS) between patients with or without COVID-19 (AIII).
Canadian Pharmacists Association

“There is insufficient evidence that NSAIDs negatively impact morbidity or mortality of COVID-19.  Health Canada continues to recommend both ibuprofen and acetaminophen for treatment of fever due to COVID-19.”7

Canadian Paediatric Society

“While there may be reasons to be cautious with NSAID therapy in older adults, there is no evidence that parents and clinicians caring for children over 6 months of age with suspected COVID-19 should avoid the use of ibuprofen for fever control.”8

Guidance for COVID-19 in Children published on Mar 25, 2020 recommends that current data and best practice both support the use of either acetaminophen or ibuprofen for COVID-19 symptoms relief.9

A legacy of evidence-based safety10

Ibuprofen (the active ingredient in Advil) is a well-established medicine that when used as labeled is considered safe for fever reduction and providing pain relief.

  • It has been used by millions of consumers across 40 countries for more than 3 decades
  • It has been extensively studied and is strictly regulated to ensure its use complies with local healthcare authority requirements
  • It has been used extensively 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.

Please consult the Product Monograph available upon request (1-855-367-7349) or on the Health Canada website for information to assist in benefit-risk assessment. Always direct the patient to read the label. Terms of Market Authorization is also available upon request through 1-855-367-7349.

  • Is ibuprofen safe to use in patients with novel coronavirus disease 2019 (COVID-19)?

    According to major regulatory bodies, there is no evidence to suggest otherwise. Ibuprofen (the active ingredient in Advil) is a well-established medicine that when used as labeled is considered safe for fever reduction and providing pain relief.10

    • It has been used by millions of consumers across 40 countries for more than 3 decades
    • It has been extensively studied and is strictly regulated to ensure its use complies with local healthcare authority requirements
    • It has been extensively used to relieve some of the symptoms of influenza (pain and fever)

  • Where did the concern about ibuprofen use in patients with COVID-19 originate from?

    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.11 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.

  • What are the clinical data for the the underlying basis for concern?

    • 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 non-survivors 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

  • What did the recent article in The Lancet Respiratory Medicine hypothesize about the use of ibuprofen in patients with COVID-19?

    An article published in The Lancet Respiratory Medicine on March 11, 2020 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.11

    • 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 ACE2.12

    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.

  • What is Health Canada’s position on the use of ibuprofen in patients with COVID-19?

    There is no scientific evidence that establishes a link between ibuprofen, or other non-steroidal anti-inflammatory drugs (NSAIDs), and the worsening of COVID-19 symptoms. The Government of Canada is monitoring the situation closely, including reviewing new information and reports as they become available, and will take the appropriate action to help protect the health and safety of Canadians.2  When choosing a fever or pain relief medication for COVID-19, patients and healthcare professionals should consider all available treatment options, including acetaminophen and NSAIDs.2,3

  • What is the World Health Organization’s (WHO) position on the use of ibuprofen in patients with 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.”4

    A rapid systematic review was carried out by the WHO on 20 March 2020 with the aim to assess the effects of prior and current use of NSAIDs in patients with acute viral respiratory infections on acute severe adverse events, acute health care utilization, as well as on quality of life and long-term survival. The review included studies conducted in humans of any age with viral respiratory infections exposed to systemic NSAIDs of any kind. All studies on COVID-19, the Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS) were included irrespective of their sample size. The review concluded that at present there is no evidence of severe adverse events, acute health care utilization, long-term survival, or quality of life in patients with COVID-19, as result of the use of NSAIDs. A Scientific Brief was published on 19 April 2020 detailing the Methods, Results, and Limitations of the systematic review5.

  • What is the National Institutes of Health’s (NIH) position on the use of ibuprofen in patients with COVID-19?

    The NIH COVID-19 Treatment Guidelines recommend the following for the use of NSAIDs in patients with COVID-196:

    • Persons with COVID-19 who are taking NSAIDs for a co-morbid condition should continue therapy as previously directed by their physician (AIII).
    • The Panel recommends that there be no difference in the use of antipyretic strategies (e.g. with acetaminophen or NSAIDS) between patients with or without COVID-19 (AIII).

  • What is the position of specific Canadian Health Professional Societies on the use of ibuprofen in patients with COVID-19?

    Canadian Pharmacists Association: “There is insufficient evidence that NSAIDs negatively impact morbidity or mortality of COVID-19.  Health Canada continues to recommend both ibuprofen and acetaminophen for treatment of fever due to COVID-19.”7

    Canadian Paediatric Society: “While there may be reasons to be cautious with NSAID therapy in older adults, there is no evidence that parents and clinicians caring for children over 6 months of age with suspected COVID-19 should avoid the use of ibuprofen for fever control.”8

    Guidance for COVID-19 in Children published on Mar 25, 2020 recommends that current data and best practice both support the use of either acetaminophen or ibuprofen for COVID-19 symptoms relief.9

  • What is GSK doing to ensure that the latest information about Advil’s safety is being provided?

    As we continue to closely monitor COVID-19 and Advil use, we will remain 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 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.

  • Where can I find more information about the safety of ibuprofen?

    Please call 1-855-367-7349 for more information about Advil and its established safety profile.

  • What resources are available for me to provide to my patients who want more information about ibuprofen use in COVID-19?

    You and your patients can visit https://www.advil.ca/coronavirus/faqs for important resources about COVID-19 and ibuprofen use.  Please also continue to visit GSK Health Partner for future updates.