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Evaluation of potential therapies for COVID-19 global pandemic
DOI 10.1007/s40278-020-78196-3, Volume: 1803, Issue: 1,

Table of Contents

Highlights

Notes

Evaluation of potential therapies for COVID-19 global pandemic

As investigations of potential therapies against coronavirus disease (COVID-19) increase globally, it is important to report any suspected adverse effects, say European regulatory authorities.1,2,3

Firstly, the EMA and national competent authorities are reminding patients with confirmed or suspected COVID-19 to report any suspected adverse effects they may experience with any medicines 1 they receive.1

The EMA highlighted that "understanding of the new virus is still incomplete, including possible interactions with medicines patients might be taking. By reporting suspected side effects of medicines used in the context of COVID-19, patients and healthcare professionals can help gather valuable evidence to inform decisions on the safe and effective use of medicines as the pandemic evolves".

Patients and healthcare professionals are encouraged to directly report any suspected adverse reactions to their national authority and to include the specified information 2 where possible.

The EMA also issued a reminder of the risk of serious adverse reactions with two medicines, chloroquine and hydroxychloroquine, which are currently authorised for the treatment of malaria and certain autoimmune diseases.2

The agency stated that "recent studies have reported serious, in some cases fatal, heart rhythm problems with chloroquine or hydroxychloroquine, particularly when taken at high doses or in combination with the antibiotic azithromycin". In addition, chloroquine and hydroxychloroquine may potentially cause liver and kidney problems, nerve damage that could result in seizures, and hypoglycaemia.

Furthermore, some of the current clinical trials of chloroquine and hydroxychloroquine for COVID-19 are using higher doses than those recommended for authorised indications − which could further increase the risk of the above-mentioned adverse reactions.

Finally, the UK's MHRA is working closely with the Department of Health & Social Care and other healthcare partners on prioritising COVID-19 investigations − including vaccine development, clinical trials of medicines, and managing the supply of medicines and healthcare products.3 The MHRA has advised that "during the pandemic, healthcare professionals, patients, and caregivers are asked to submit all suspected side effect reports electronically to enable us to process reports while working remotely".

Notes

1 including any used to specifically treat COVID-19 (including any medicines used off-label), and any medicines taken for the long-term management of pre-existing conditions.
2 including patient information (including age and gender); whether COVID-19 infection was confirmed through testing, or was based on clinical symptoms; a description of the adverse reactions; the name of medicine (i.e. active ingredient + brand name) suspected to have caused the adverse reactions; the dose and duration of treatment with the medicine; and the batch number of the medicine.

References

1 

1. European Medicines Agency. Reporting suspected side effects of medicines in patients with COVID-19. Internet Document : 24 Apr 2020. Available from: URL: https://www.ema.europa.eu/en/news/reporting-suspected-side-effects-medicines-patients-covid-19

2 

2. European Medicines Agency. COVID-19: reminder of risk of serious side effects with chloroquine and hydroxychloroquine. Internet Document : [2 pages], 23 Apr 2020. Available from: URL: https://www.ema.europa.eu/en/news/covid-19-reminder-risk-serious-side-effects-chloroquine-hydroxychloroquine

3 

3. Medicines and Healthcare products Regulatory Agency (UK). Coronavirus (COVID-19): latest guidance for medicines safety. Drug Safety Update 13: 2-4, No. 9, Apr 2020. Available from: URL: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/881559/April-2020-DSU-PDF.pdf

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