EU regulator starts safety review of coronavirus drug over reports of kidney problems

Coronavirus

(Photo by ULRICH PERREY/POOL/AFP via Getty Images)

LONDON — The European Medicines Agency has started a safety review after some patients taking the coronavirus drug remdesivir reported serious kidney problems.

The EU regulator says it isn’t clear whether remdesivir is causing the reports of “acute kidney injury,” but that the issue “warrants further investigation.”

Remdesivir was given a conditional marketing authorization by the EMA on July 3 and can be used to treat people older than 12 with severe COVID-19 who require oxygen treatment. The approval for the drug was fast-tracked with the understanding that more evidence would be submitted after a license was granted

The EMA says the potential problem of kidney toxicity caused by remdesivir was evaluated when the conditional approval was given, mainly based on animal studies. It noted that kidney injuries can be caused by other factors, including diabetes and the coronavirus.

The regulator says recommendations for the use of remdesivir remain unchanged; doctors are already advised to monitor patients for kidney complications before starting treatment and not use the drug in patients with known kidney problems.

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