Thread by @nickpwing

.@US_FDA gives update on its review of kratom. A few takeaways: Using a new computational model, the agency feels "confident in calling compounds found in kratom, opioids."

FDA is also updating its total count of kratom-associated deaths to 44, and has released reports regarding the 36 deaths it referenced in November. Here’s a link.

fda.gov/downloads/Drug…

Trying to figure out what this means in terms of immediate FDA/DEA action on kratom. This conclusion sounds more tempered than previous ones, but likely won’t provide much comfort to the kratom community.

Here’s a link to the full FDA release on "scientific analysis providing even stronger evidence of kratom compounds’ opioid properties"

fda.gov/NewsEvents/New…

FDA spox says no updates on scheduling decision — that’s up to DEA — but "FDA is continuing to monitor and will continue to take action as necessary (stopping imports, product seizures, etc.)."

Worth noting that FDA’s full list of 36 kratom-associated deaths still includes fatalities related Krypton, a controversial product that contained O-Desmethyltramadol

I don’t see how it helps FDA’s case to count incidents like this as kratom-related deaths.

Patient tested positive for 6 substances, was "found naked with empty pill bottles which were believed to be antianxiety."

Interesting case of supposed kratom-associated death. Patient with history of seizures determined to have “no significant natural disease,” but also had what seems like impossibly high concentration of mitragynine in liver?

Helpful kratom-associated death case here. 8 pages of complete redaction.

Another case that doesn’t seem very informative as to how kratom supposedly causes fatal harm. Patient tested positive for 8 substances, including heroin and 5 different benzodiazepines

This case involves a very high concentration of mitragynine (at least to my understanding). But patient also tested positive for fentanyl, benzodiazepines and had a history of drug and alcohol abuse.

This case really demonstrates just how weak FDA's data can be. Patient hanged himself, had history of depression/suicidal ideations, RX drug abuse. But also tested positive for high levels of mitragynine and other drugs.

I’m confused. Other medical examiners have determined that mitragyinine concentrations of this level (.74 mg/L) should be fatal. Yet they didn’t kill this patient. He hanged himself.

Another case of a patient with a history of steroid use. Tox screen doesn’t test for steroids. Also tested for high levels of methadone. Again, presence of arbitrary “toxic” level of mitragynine appears to have led to conclusion it was a kratom-related death.

I don’t even know what to say about this case. But I think any reasonable person could see how singling out kratom from this laundry list might be a stretch.

Very little info about this case. Haven’t seen concentrations this high, including in case of NY police officer who died of “kratom overdose” last year. 39-year-old white male, report received in October. Any ideas?

One of the final cases involves a patient who tested positive for 9 different substances and refused care after falling out a window and breaking his arm. That said, also a high level of mitragynine.

Can confirm that 9 of the 36 (now 44) supposed kratom-related deaths FDA cites stem from the 2011 report on Krypton deaths in Sweden.

Krypton was a kratom-derived product that also contained dangerous amounts of O-desmethyltramadol. Hard to call it kratom, but the fact that products like this pop up at all speaks to the grey area FDA appears intent on trying to eliminate.