FDA Warns Monkeypox Could Mutate and Resist Treatment If Antiviral Drug Is Overused

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FDA Warns Monkeypox Could Mutate and Resist Treatment If Antiviral Drug Is Overused
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U.S. health officials are warning against overuse of the lone drug available to treat monkeypox, saying that even a small mutation in the virus could render the pills ineffective.

Doctors wishing to prescribe the drug must submit an application to the Centers for Disease Control and Prevention, documenting their patient’s need and agreeing to track their results and any side effects. Officials have shipped 37,000 courses of the drug to physicians.

During a White House briefing, CDC Director Dr. Rochelle Walensky attributed the decline to vaccinations, educational outreach and individuals reducing behaviors linked to spread. The vast majority of U.S. cases have been in men who have sex with men, though officials emphasize that the virus can infect anyone.

But no changes were made to allow emergency use of Tpoxx, stoking complaints from groups representing gay and bisexual men. Even though the drug was approved for smallpox, its effectiveness was measured in monkeys infected with monkeypox, considered a reasonable predictor of smallpox’s effect on humans. Animals receiving Tpoxx survived at higher rates than those on a placebo. But FDA officials have cautioned that results in animals must be confirmed in human testing.

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