FDA Warns Sites Over Malaria Drug COVID-19 Claims

By Emily Field
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Law360 (February 2, 2021, 5:02 PM EST) -- The U.S. Food and Drug Administration on Tuesday said it had fired off warning letters to three online sellers of malaria drug hydroxychloroquine over unfounded claims that it can treat or prevent COVID-19.

In the warning letters, dated Jan. 28, the FDA said it had visited the websites — www.rx2go.com, www.buy‐pharma.md and www.sandra‐pharma.is — earlier that month and saw they offered hydroxychloroquine as a treatment or cure for the novel coronavirus, which is not an FDA-approved application of the drug. They also hawked an antibiotic called azithromycin as a cure for COVID-19, which is a prescription-only drug labeled for treating mild to moderate bacterial infections, such as conjunctivitis, according to the letters.

Sales of these unapproved drugs are violations of the Federal Food, Drug and Cosmetic Act, the letters said.

One of the websites, www.sandra-pharma.is, said both hydroxychloroquine and azithromycin have been used to cure COVID-19 patients in the U.S. and "many other countries in the world," the FDA said.

That website and www.buy-pharma.md were offline as of Tuesday. Representatives for www.rx2go.com didn't immediately respond to request for comment.

"Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether," the FDA said. "We request that you cease the sale of any unapproved and misbranded products, whether for the mitigation, prevention, treatment, diagnosis, or cure of COVID‐19, or any other disease for which the drugs you are selling are not approved by FDA for distribution in the U.S."

The FDA requested that the companies respond within 48 hours with the steps taken to correct the violations.

Early in the pandemic, former President Donald Trump touted without evidence that hydroxychloroquine was a "game changer" in treating the coronavirus.

After Trump boosted the drug in April, later that month the FDA warned that the malaria drug had been reported as causing life-threatening heart rhythm problems.

At the time, hydroxychloroquine and another malaria drug were being used as a treatment in limited circumstances under an emergency use authorization, or EUA, for adolescent and adult patients.

Two months later, the agency revoked the EUA, warning that they're probably not effective against it and may even interfere with a coronavirus drug sold by Gilead Sciences Inc.

The agency said new research revealed that the drugs "are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA," adding that "the totality of scientific evidence currently available indicate a lack of benefit."

The risk of side effects may increase when the drugs are combined with other drugs currently being used to treat COVID-19, according to the agency.

Patients with other health issues, such as heart and kidney disease, are likely to be at increased risk of heart problems when taking hydroxychloroquine and chloroquine, the FDA added.

The FDA has continued to send out warnings throughout the pandemic over unbacked claims that products can treat or cure COVID-19, most recently targeting sellers of stem cell products and dental rinses in November.

--Editing by Stephen Berg.

For a reprint of this article, please contact reprints@law360.com.

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