FDA warns website to stop unlawful sale of 'unapproved, misbranded' hydroxychloroquine
The FDA has issued a warning letter to an online pharmacy for allegedly selling unapproved and misbranded drugs, including hydroxychloroquine and chloroquine, for the treatment of COVID-19, lupus, rheumatoid arthritis and other diseases.
According to the FDA, the website, pharmacygeoff.md, offers misbranded versions of the drugs Plaquenil (Hydroxychloroquine Sulfate, Sanofi), chloroquine, lopinavir/ritonavir (Kaletra, Abbott), ribavirin and dexamethasone, claiming consumers can use them to treat COVID-19 as well as a host of other conditions. Products for sale at the website also constitute unapproved new drugs, the FDA said, as they are not generally recognized as safe and effective for their labeled uses.
“FDA is taking this action against www.pharmacygeoff.md because of the inherent risk to consumers who purchase misbranded and unapproved new drugs,” read the warning letter, dated April 15, 2021, and signed by Donald D. Ashley, director of the Office of Compliance at the FDA Center for Drug Evaluation and Research.
“You should take prompt action to address any violations of the [Federal Food, Drug, and Cosmetic (FD&C) Act] (which may include the offer for sale of similarly misbranded and/or unapproved new drugs other than the drugs noted above),” the letter adds. “We advise you to review your websites, product labels and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and effective for a use for which they have not been approved by FDA and that you do not make claims that misbrand the products in violation of the FD&C Act.”
The letter follows a review of the website conducted by the FDA on March 22, in which the administration found several unapproved and misbranded prescription drugs allegedly being offered for sale directly to consumers.
Among these drugs was a product labeled “Plaquenil (Hydroxychloroquine Sulfate).” According to the FDA, the pharmacygeoff.md website claims this product “has recently been used to treat patients with COVID-19,” in addition to inflammatory conditions and malaria.
“While there are FDA-approved versions of hydroxychloroquine, including ‘Plaquenil,’ on the market in the U.S., there are no approved drug applications ... in effect for the ‘Plaquenil (Hydroxychloroquine Sulfate)’ manufactured by Sanofi and offered by www.pharmacygeoff.md,” according to the warning letter. “FDA-approved hydroxychloroquine is labeled for the treatment of uncomplicated malaria, discoid and systemic lupus erythematosus, and acute and chronic rheumatoid arthritis and is only available by prescription. In addition, hydroxychloroquine has not been approved by FDA for use in the prevention, diagnosis, treatment, mitigation, or cure of COVID-19.”
Another unlawful product allegedly offered by the company is chloroquine, marketed on the website as “Lariago-DS (Chloroquine).” The online pharmacy claims, “there are medical professionals out there using Chloroquine (Lariago DS) along with zinc to help fight COVID-19, the Coronavirus,” and, “the biggest benefit of Chloroquine (Lariago DS) for coronavirus is it helps to fight the intense fever.”
Again, although there are FDA-approved versions of chloroquine on the market in the United States, there are no approved drug applications for the “Lariago-DS (Chloroquine)” offered by pharmacygeoff.md, the administration said.
“FDA-approved chloroquine is labeled for the treatment of certain types of malaria and extraintestinal amebiasis, and is only available by prescription,” read the letter. “In addition, chloroquine has not been approved by FDA for use in the prevention, diagnosis, treatment, mitigation, or cure of COVID-19.”
Other products, marketed by the company as “Hivus-LR (Lopinavir/Ritonavir),” “Lopimune (Lopinavir/Ritonavir),” “Ribasure (Ribavirin),” and “Dexona (Dexamethasone)”, also appear on the website under the heading “Coronavirus/COVID-19.”
Under the website’s “About us” section, Pharmacy Geoff describes itself as an online pharmacy that has been “trading for over four years and has over 10,000 customers worldwide, many of whom have dealt with us from day one.”
The company also states: “Pharmacy Geoff operates within all regulations and laws of Hong Kong SAR. All products being handled have been issued the necessary import and export licenses, individually issued for each product by the Hong Kong Health Department.”
The FDA has given the company 48 hours from the receipt of the letter to contact the administration regarding specific steps its leadership plans to take to address the alleged violations.
Failure to adequately address the matter may result in legal action, including seizure and injunction, the FDA said.