FDA grants emergency use of malaria drugs against COVID-19
The FDA has approved emergency use of malaria drugs championed by president Donald Trump for use in patients hospitalised with COVID-19, after warning against the potentially lethal consequences of taking chloroquine preparations intended for use against parasites in aquarium fish.
There is only sketchy evidence that chloroquine and hydroxychloroquine work against the coronavirus that causes COVID-19.
Most of the evidence to support use of chloroquine or the less toxic hydroxychloroquine against the disease comes from a small trial in France, which in normal circumstances would suggest the drug merits further investigation.
But in the frenzy to find drugs for the currently untreatable COVID-19, governments including the US are trying to get their hands on chloroquine.
Trial evidence has shown toxicity issues with chloroquine, also used in lupus and rheumatoid arthritis, which can permanently damage the eye and cause vision loss if used in the long term.
The US Department of Health and Human Services said it had accepted 30 million doses of hydroxychloroquine sulfate donated by Novartis’ Sandoz generics division, and a million doses of chloroquine phosphate donated by Bayer.
At the same time the FDA issued an Emergency Use Authorization allowing the US government’s Biomedical Advanced Research and Development Authority to place the drugs in a national stockpile for prescription and distribution to hospitalised teens and adults with COVID-19.
This is not a full approval as large scale trials have not tested the safety and efficacy of chloroquine-type drugs in COVID-19.
The decision came after the FDA on Friday issued a separate warning against using chloroquine phosphate used to treat disease in aquarium fish.
It emerged that a man in Arizona died and his wife was hospitalised in a critical condition after drinking chloroquine phosphate used to treat fish parasites hoping it would prevent coronavirus infection.
The woman recognised the name “chloroquine” when she heard Trump back its safety because she had used it to treat her Koi carp.
They each mixed a teaspoon of chloroquine phosphate with soda and within 20 minutes the woman began vomiting and her husband had trouble breathing and both were admitted to a Banner Health hospital, which issued the warning against self-medicating with chloroquine.
Similar cases have been reported in Nigeria and the FDA’s Center for Veterinary Medicine warned against taking any form of chloroquine unless prescribed by a licensed healthcare provider and obtained through a legitimate source.
The FDA added: “Chloroquine products sold for aquarium use have not been evaluated by the FDA to determine whether they are safe, effective, properly manufactured, and adequately labelled for use in fish - let alone humans.”