Combating Misinformation and Learning The Facts

As we all struggle through this unprecedented health situation with the novel coronavirus (COVID-19), oftentimes misinformation and speculation can contribute to worldwide anxiety and confusion. 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 addressing your questions and concerns. As your trusted partner in the healthcare, we are committed to supporting you.

THE FACTS ABOUT IBUPROFEN AND COVID-19

Find out more at www.Advil.com. If concerned, please contact your Doctor.

Here are the facts:

An article recently published in The Lancet Respiratory Medicine hypothesized a connection between ibuprofen and worsening COVID-19 outcomes. The authors cited receptor modeling in an attempt to predict the ACE2 interactions of SARS-CoV-2. They hypothesized the expression of ACE2 was substantially increased in patients treated with angiotensin converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs). Actual treatment with ACEi or ARBs was not assessed in the 3 primary publications. Link

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.

A legacy of evidence-based safety5

Ibuprofen is a well-established medicine that when used as labeled is safe to reduce fevers and provide pain relief.

• 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
• With over 30 years of monitoring and post marketing surveillance reporting adverse events (AEs) to the FDA, no signal or marker has come up related to worsening viral infections
• It has been extensively used to relieve some of the symptoms of influenza (pain and fever)

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. “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,” Dr. Anthony Fauci, 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.”

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.