Other safety alerts
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| European Union: EMA advises against use of ivermectin for the prevention or treatment of COVID-19 outside randomised clinical trials |
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European Medicines Agency (EMA) announces that it has reviewed the latest evidence on the use of ivermectin for the prevention and treatment of COVID-19 and concluded that the available data do not support its use for COVID-19 outside well-designed clinical trials.
In the European Union, ivermectin tablets are approved for treating some parasitic worm infestations while ivermectin skin preparations are approved for treating skin conditions such as rosacea. Ivermectin is also authorised for veterinary use for a wide range of animal species for internal and external parasites.
Ivermectin medicines are not authorised for use in COVID-19 in the European Union, and EMA has not received any application for such use.
Following recent media reports and publications on the use of ivermectin, EMA reviewed the latest published evidence from laboratory studies, observational studies, clinical trials and meta-analyses. Laboratory studies found that ivermectin could block replication of SARS-CoV-2 (the virus that causes COVID-19), but at much higher ivermectin concentrations than those achieved with the currently authorised doses. Results from clinical studies were varied, with some studies showing no benefit and others reporting a potential benefit. Most studies EMA reviewed were small and had additional limitations, including different dosing regimens and use of concomitant medications. EMA therefore concluded that the currently available evidence is not sufficient to support the use of ivermectin in COVID-19 outside clinical trials.
Although ivermectin is generally well tolerated at doses authorised for other indications, side effects could increase with the much higher doses that would be needed to obtain concentrations of ivermectin in the lungs that are effective against the virus. Toxicity when ivermectin is used at higher than approved doses therefore cannot be excluded.
EMA therefore concluded that use of ivermectin for prevention or treatment of COVID-19 cannot currently be recommended outside controlled clinical trials. Further well-designed, randomised studies are needed to draw conclusions as to whether the product is effective and safe in the prevention and treatment of COVID-19.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/ema-advises-against-use-ivermectin-prevention-treatment-covid-19-outside-randomised-clinical-trials
In Hong Kong, there is one registered pharmaceutical product for human use containing ivermectin, namely Soolantra Cream 10mg/g (HK-64980). The product is registered by Galderma Hong Kong Limited, and is a prescription-only medicine. The product is indicated for the topical treatment of inflammatory lesions of rosacea in adult patients. The Department of Health will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities.
Ends/Tuesday, Mar 23, 2021
Issued at HKT 15:00
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