Two Companies Hit With FDA Warning Letters for Selling Unapproved and Misbranded Drugs for COVID-19
The FDA has accused two overseas companies of selling unapproved and misbranded drugs for COVID-19 to U.S. customers over the internet.
Cyprus-based rxshopmd.com and Russia-based extrapharmacy.ru were hit with warning letters after the FDA reviewed their websites and saw unapproved drugs for sale without a prescription for the mitigation, prevention, treatment, diagnosis or cure of COVID‐19, as well as for other diseases.
On Feb. 16, both companies were asked to cease sale of any unapproved and misbranded products and to contact FDA within 48 hours of receiving the letter.
However, as of Feb. 23, rxshopmd.com was still selling Hivus-LR Lopinavir + Ritonavir as a both a COVID-19 treatment and an HIV drug. This is one of the products the FDA mentioned specifically in its warning letter to the company.
While there are FDA-approved versions of lopinavir plus ritonavir, including AbbVie’s Kaletra, on the market in the U.S., there are no approved drug applications for the Hivus‐LR (lopinavir + ritonavir 200/50 mg) manufactured by Aurobindo Pharma and offered by www.rxshopmd.com, the FDA said.
The agency sent essentially the same letter to extrapharmacy.ru, though it pointed out to extrapharmacy.ru that it is also selling unapproved and misbranded drugs that are labeled as treating systemic lupus erythematosus, rheumatoid arthritis and malaria.
The agency said extrapharmacy.ru was selling Plaquenil (hydroxychloroquine) as a treatment for COVID-19, adding that hydroxychloroquine has not been approved by the FDA for use in the prevention, diagnosis, treatment, mitigation or cure of COVID-19.
FDA-approved hydroxychloroquine is labeled for treatment of uncomplicated malaria, discoid and systemic lupus erythematosus, and acute and chronic rheumatoid arthritis, and is only available by prescription, the agency noted.
As of Feb. 23, extrapharmacy.ru was still selling Plaquenil (hydroxychloroquine) but no longer appears to be marketing it as a treatment for COVID-19.
“Unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight,” wrote the FDA to both companies. “Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients or contain different ingredients altogether.”
Neither company responded to requests for comment.
Read the two warning letters here: www.fdanews.com/02-23-22-WarningLetters.pdf. — Suz Redfearn