Preliminary Analysis of FDA “Kratom-related” Deaths Contributors: Heather G., Rachel W., John D.
Preliminary Analysis of FDA’s 36 Kratom-related Deaths
Source of data for deaths: FDA Adverse Events Reporting System (FAERS) Public Dashboard
Notable Drugs
Notable drugs were defined as drugs known to be potentially dangerous either alone, or when mixed or other substances, or drugs that are often abused.
- 100% of cases had substances other than kratom in their system
- More than 1/3 of cases (33%) had controlled substances in their system at the time of death
- 13% had Multiple controlled substances in their system at once
- 36% had an SSRI in their system, almost half of which were CelexaPercentage of total cases, by notable substance (rounded to the nearest whole number):
|
Type |
# Cases |
% Total cases |
|
Quinine/Quinidine |
16 |
44% |
|
Anti-Diarrheal (Loperamide) |
15 |
42% |
|
SSRI |
14 |
39% |
|
Antipsychotic |
12 |
33% |
|
Benzodiazepine |
11 |
31% |
|
Analgesic |
10 |
28% |
|
Anticonvulsant |
10 |
28% |
|
Anti-Histamine |
6 |
17% |
|
Beta Blocker |
6 |
17% |
|
Alcohol |
4 |
11% |
|
Unknown Substance |
2 |
6% |
|
Sedative |
1 |
3% |
|
Stimulant |
1 |
3% |
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Preliminary Analysis of FDA “Kratom-related” Deaths Contributors: Heather G., Rachel W., John D.
About Imodium (Loperamide) abuse:
Loperamide abuse is increasingly common.
According to the FDA’s 2016 report: “The U.S. Food and Drug Administration (FDA) is warning that taking higher than recommended doses of the common over-the-counter (OTC) and prescription diarrhea medicine loperamide (Imodium), including through abuse or misuse of the product, can cause serious heart problems that can lead to death. The risk of these serious heart problems, including abnormal heart rhythms, may also be increased when high doses of loperamide are taken with several kinds of medicines that interact with loperamide… The majority of reported serious heart problems occurred in individuals who were intentionally misusing and abusing high doses of loperamide in attempts to self-treat opioid withdrawal symptoms or to achieve a feeling of euphoria.”[1]
Anecdotal reports from internet forums have shown some users take up to 100 Imodium tablets to achieve these effects.
A notable 42% of the 36 reported deaths had Loperamide in their system.
About Quinine/Quinidine abuse:
Quinine is a malaria drug derived from the bark of the Cinchona tree, sometimes used for relief of leg cramps.
According to anecdotal reports from internet forums, Quinine or Quinidine is also sometimes used to potentiate Loperamide and assist with crossing the blood-brain barrier.
Web MD reported [2] on an FDA warning pertaining to the use of Quinine in an article, which stated the following possible side-effects:
- Potentially serious interactions with other drugs
- Abnormal heart rhythms
- Thrombocytopenia, a blood platelet disorder that can cause hemorrhage or clotting problems
- Severe hypersensitivity reactionsA few Notable Cases (As researched by Rachel W. & John D.)
NOTE: Many cases seemed notable, these are just a small sample
|
Case # |
Note |
|
13407030 |
Subject had 3 Benzodiazepines, 3 antipsychotics and an SSRI in their system as well as lyrica. Many of these medications have a relatively high risk of adverse effects including death on their own. |
|
13421666 |
Reported to have the exact same combination of substances as 13407030 |
|
8124388 |
Had 4 controlled substances in their system |
|
1269332 |
Had 5 controlled substances in their system |
|
12639594 |
Multiple potential interactions between prescription drugs found in this subject’s system, the most serious being Serotonin Syndrome. Subject had multiple serious conditions including nephrosclerosis, arteriosclerosis coronary artery, pneumonia and hepatic steatosis. |
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Preliminary Analysis of FDA “Kratom-related” Deaths Contributors: Heather G., Rachel W., John D.
|
12639579 |
This case specifically notes respiratory arrest and a puncture sight reaction, strongly suggestion IV methadone use (which is known to cause reactions at injection sites, particularly when illicitly used. Benzodiazepines are contraindicated for use with opioids. CNS sedation and respiratory depression can and often is exacerbated by coadministration. |
|
12639556 |
Ruled a Suicide |
|
12639332 |
Alcohol poisoning indicated during toxicology |
|
12639316 |
Ruled as a homicide with cause of death due to traumatic lung injury, chest injury, aortic injury, gunshot wound. |
|
8121551 |
There are major drug interactions between Amphetamines (Adderall) and Prozac and moderate drug interactions between Prozac and Lyrica. It is noted that the subject suffered Cardiac arrest, lost consciousness, toxicity to various agents, pulmonary congestion, and hepatic steatosis (fatty liver disease). |
|
8121536 |
there are known interactions between Effexor and Remeron, Trimeprazine and Tramadol, and Tramadol and Effexor for things such as Serotonin Syndrome, respiratory depression, and seizure. Buprenorphine is a narcotic used to treat pain as well as addiction to narcotic medications. There is a major interaction between Buprenorphine and Valium for respiratory depression and death. It is noted that the subject presented with pulmonary edema, cardiac arrest, loss of consciousness, toxicity to various agents, and brain edema. |
|
8083892 |
Same drug combinations as 8121536. Multiple drugs with major interactions found in their system |
|
10698706 |
Serious, multiple drug interactions |
|
8132531 |
The use of tramadol with xanax is contraindicated |
Link to detailed research compiled by the contributors on all 36 cases, including sources (NOTE: URL was too long to be practical. This link redirects to the file on Google Docs):
https://tinyurl.com/fdakratomdetails
Link to data table of cases and substance data for analysts:
https://preview.tinyurl.com/FDAKratomdatatable
Caveats:
- This analysis was completed very quickly due to pressing need for data for a scheduled meeting. It is possible that small errors exist, as there was not much time for peer review.
- None of the people involved in this report have medical or scientific training or degrees, with the exception of John D., who has a research background in the field of Chemical Engineering. We are volunteers. The author of this document has experience as a data analyst. It is hoped by the contributors to this report that someone who does have training in those areas will take an interest in this preliminary analysis and review this data and produce their own scientific reports.
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Preliminary Analysis of FDA “Kratom-related” Deaths Contributors: Heather G., Rachel W., John D.
SOURCES
[1] Fda.gov. (2017). FDA Drug Safety Communication: FDA warns about serious heart problems with high doses of the antidiarrheal medicine loperamide (Imodium), including from abuse and misuse. [online] Available at: https://www.fda.gov/Drugs/DrugSafety/ucm504617.htm [Accessed 14 Dec. 2017]. [2] Fda.gov. (2017). FDA Drug Safety Communication: FDA warns about serious heart problems with high doses of the antidiarrheal medicine loperamide (Imodium), including from abuse and misuse. [online] Available at: https://www.fda.gov/Drugs/DrugSafety/ucm504617.htm [Accessed 14 Dec. 2017].Contributors to this report:
Heather G – Data Analysis, report compilation Rachel W – Research and Analysis
John D – Research and Analysis
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