Important Information About Newly Approved Anti-Malarial Drug Arakoda.
60P’s first significant shipment of Arakoda occurred in September, 2019, to the U.S. Army. The product is now commercially available via select retail pharmacy outlets and pharmaceutical wholesalers. 60P continues to work closely with distribution networks and third-party insurance companies to provide extensive access to the product.
Arakoda™ (Tafenoquine) Tablets, First Prescription Drug Approved for Malaria Prevention by US FDA in Over 18 Years, Now Available in US
https://www.prnewswire.com/news-releases/arakoda-tafenoquine-tablets-first-prescription-drug-approved-for-malaria-prevention-by-us-fda-in-over-18-years-now-available-in-us-300962690.html
If you are an active duty soldier in the United States Army and are awaiting deployment overseas, there is some important information that you need to made aware of concerning a new anti-malarial drug called tafenoquine (brand name Arakoda).
Serious concerns have been raised about the safety of this drug that you need to be aware of before taking it. It has been found that critical drug safety data was omitted from the FDA New Drug Application for Arakoda, information about serious adverse psychiatric reactions to tafenoquine was not made available to the FDA.
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 210607Orig1s000
OTHER REVIEW(S)
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210607Orig1s000OtherR.pdf
It calls into question the data from several clinical trials of tafenoquine, including Study 033 which took place from 2000-2001 on the island of East Timor using members of the Australian Defense Force as test subjects. There is a vast amount of evidence to indicate that there were numerous serious reactions that were not reported and as such the safety of this drug is now seriously in question. There is sufficient evidence to warrant federal agencies to launch investigations into a number of apparent regulatory, ethical, and CRIMINAL violations surrounding the approval of Arakoda including fraud and conspiracy to commit fraud against the United States Government
“Crazy stuff started happening. We had a guy from my own company who ended up pulling a para flare apart, for no reason. No-one does that stuff. The next minute, we got back to our FOB and he ended up taking one of my mate’s grenades. At that time we’d had a change in the grenade—once the pin was pulled out, you couldn’t put it back in unless you had a special tool. He ended up throwing that grenade. The grenade went off and he ended up fragging himself. He just wigged out.”
Testimony of an Australian Army tafenoquine Study 033 trial subject to the 2018 Australian Senate Inquiry into Quinoline Antimalarials in the ADF
There are also issues surrounding the efficacy and safety of this drug in people who are deficient in particular enzymes (G6PD and CYP-2D6). Patients would need to have a blood test to screen for this PRIOR to taking Arakoda and MUST be made aware of this.
Discuss It With Your Medical Officer
The bottom line is if you are being deployed to a malaria zone and have been prescribed Arakoda, you should seek an alternative to it. Your life may well depend on it.
References
Australian Defense Forces Brass Engineer Cover-Up Of A Drug Trial That Tested A Controversial Anti-Malarial.
The Quinism Foundation Shares Its Concerns that the GlaxoSmithKline (GSK) Antimalarial Drug Tafenoquine is Neurotoxic
https://www.prweb.com/releases/2018/07/prweb15612420.htm
Unexpected pharmacological and toxicological effects of tafenoquine
Tafenoquine versus primaquine to prevent relapse of plasmodium vivax malaria
Soldiers scarred by antimalarial drugs to receive health check
https://www.canberratimes.com.au/story/6278281/health-checks-for-soldiers-part-of-trial/
The Advocate-Equalizer 
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