Caution Urged in the Use of Tafenoquine Against COVID-19

In the wake of evidence of patient harms and deaths following early interest in the use of hydroxychloroquine and chloroquine against COVID-19, The Quinism Foundation has urged caution in the similar use of tafenoquine, after the manufacturer of the Arakoda® brand of the drug suggested their product may also have potential utility against the disease.

As described in a recent press release, 60 Degrees Pharmaceuticals (60P) will be hosting a webinar Tuesday, July 28, 2020 at 11 am EDT to discuss future plans for the testing of Arakoda® against COVID-19. Interested members of the public are encouraged to register to attend this webinar to learn more about these plans.

Tafenoquine is a neurotoxic quinoline antimalarial drug with a similar adverse effect profile to mefloquine. As noted in the foundation’s recent press release urging caution in the use of the drug, in U.S. Army research conducted prior to 60P’s commercialization of tafenoquine, the drug was found to be the most neurotoxic quinoline among six tested, including mefloquine and chloroquine.

In recognition of tafenoquine’s neuropsychiatric liability, the FDA has required language in the approved U.S. drug label for Arakoda® warning of a risk of severe psychotic reactions, and that those taking the drug should be promptly evaluated by a medical professional if psychiatric symptoms occur during use, such as changes in mood, anxiety, insomnia, and nightmares if they are moderate and last more than three days or are severe.

Foundation executive director Dr. Remington Nevin noted that although 60P’s unpublished research suggests that tafenoquine may have in vitro activity against SARS-CoV-2, the virus that causes COVID-19, both chloroquine and hydroxychloroquine initially showed similar results, without being found safe and effective following widespread clinical trials. Recently, the FDA revoked the Emergency Use Authorization for both drugs against COVID-19 following reports of widespread patient harms and deaths associated with their investigational and off-label use.

“While 60P’s results suggest promise against COVID‑19, experience with chloroquine and hydroxychloroquine should temper institutional interest in similar investigational use of tafenoquine,” said Dr. Nevin. “Patients enrolled in whatever clinical trials may proceed must be informed of tafenoquine’s inherent neurotoxicity and neuropsychiatric liability. Likewise, prescribers should exercise caution against the ill-advised off-label use of either Arakoda®- or Krintafel®-branded tafenoquine, neither of which is FDA-approved for prevention or treatment of COVID‑19.”

Tafenoquine was the focus of a recent investigative news report by WUSA9. Watch video of reporter Andrea McCarren interviewing 60P CEO Geoffrey Dow on the safety of tafenoquine here.

Suspected adverse effects from tafenoquine and related quinoline drugs may be reported to the U.S. Food and Drug Administration’s MedWatch program.