FDA warns on safety threat posed by 2 drugs initially backed by Trump for Covid-19 — following an emergency use authorization
Two of President Trump’s initial top picks as near-term therapeutic remedies for Covid-19 are the subject of an FDA safety warning today.
The agency issued an alert on Friday on hydroxychloroquine and chloroquine for “serious and potentially life-threatening heart rhythm problems, that have been reported with their use for the treatment or prevention of COVID-19.”
Trump, whose most recent musings on Covid-19 focused on the use of disinfectants (dangerous) and light (?) to stop the virus, earlier made repeated supportive comments regarding chloroquine and hydroxychloroquine, which he has cited as a powerful drug that could be a potential “game changer” and which couldn’t hurt anyone who tried it.
Both drugs are used for malaria and have become hard to find in the wake of Trump’s endorsement.
The FDA hasn’t fully approved the drugs for Covid-19, but they did provide emergency use authorization as the president extolled the therapies in his daily press conferences. More recently, press reports indicate that the president has begun to back away from these drugs, but he remains fixed on finding something handy to fight the pandemic.
Just this week, Rick Bright says he was ousted from BARDA for refusing to back hydroxy, saying he had resisted investing in therapies “that lack scientific merit.”
Biopharma experts, meanwhile, are focused on developing advanced drugs for the new virus, finding new ones or going after a vaccine. The main argument in the industry isn’t what’s needed, but how long it’s going to take.
“While clinical trials are ongoing to determine the safety and effectiveness of these drugs for COVID-19, there are known side effects of these medications that should be considered,” offered new FDA commissioner Stephen Hahn. “We encourage health care professionals making individual patient decisions closely screen and monitor those patients to help mitigate these risks. The FDA will continue to monitor and investigate these potential risks and will communicate publicly when more information is available.”
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