EMA has advised that the use of ibuprofen for COVID19 treatment will be monitored.

The EMA (European Medicines Agency) has issued a formal statement following a comment from France’s Health Minister, Oliver Veran, suggesting that patients with COVID19 symptoms should using paracetamol rather than ibuprofen.  The comment, issued on Twitter, advised that, “Taking anti-inflammatory drugs (ibuprofen, cortisone…) could be an aggravating factor for the infection. If you have a fever, take paracetamol”.  Following the media from national and international outlets, the EMA stated that, “There is currently no scientific evidence establishing a link between ibuprofen and worsening of COVID-19. EMA is monitoring the situation closely and will review any new information that becomes available on this issue in the context of the pandemic”.

 

A list of national competent agencies2 and relevant national bodies can be reviewed across Member States.  In the Irish “Heath Service Executive” (HSE), their website advised that, “It is okay to take anti-inflammatories (NSAID) if you have coronavirus. There is no evidence that they are unsafe. Only take one anti-inflammatory medication at a time. It is okay to take paracetamol and an anti-inflammatory like ibuprofen at the same time”.  In the UK, the Medicines and Healthcare products Regulatory Agency” (MHRA) stated that, “There is some debate suggesting NSAIDs may increase complications from simple acute respiratory infections or slow recovery. The product information of many NSAIDs already contains warnings that their anti-inflammatory effects may hide the symptoms of a worsening infection. However the evidence is not conclusive.  In view of the current lack of research the Commission on Human Medicines (an expert advisory body of MHRA) and NICE have been asked to review the evidence.

 

At the EMA, an original concern on ibuprofen led to a review of NSAIDs (ibuprofen and ketoprofen) in May 2019, following a survey by the French National Agency for Medicines and Health Products Safety (ANSM).  Their survey suggested that infection due to “chickenpox (varicella) and some bacterial infections could be made worse by these medicines”. In addition, Paul Little, a professor of primary care research at the University of Southampton, UK, said that there was good evidence “that prolonged illness or the complications of respiratory infections may be more common when NSAIDs are used—both respiratory or septic complications and cardiovascular complications.” He added, “The finding in two randomised trials that advice to use ibuprofen results in more severe illness or complications helps confirm that the association seen in observational studies is indeed likely to be causal. Advice to use paracetamol is also less likely to result in complications.”  If any new information arises on this data, it will be circulated at both the EMA and other relevant heath agencies.

 

  1. https://www.ema.europa.eu/en/partners-networks/eu-partners/eu-member-states/national-competent-authorities-human

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