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Noreen Martin
In 1975, I had hepatitis due to working in the dental field at a time when protective measures were not in place. I was in hospital under observation for a week and convalesced for another 3 weeks. I was diagnosed with cancer and had cancer treatment in December of 1979.
Around April 2002, my left ear was buzzing and I could not hear much in that ear for one month. I was placed on the antibiotic Cipro and had an immediate reaction to it. It looked like I had the measles from head to toe, so this was changed to Keflex for two weeks.
In July 2002 I was diagnosed with a herniated disc and pinched nerves. This story relates to a period of deteriorating health, which went downhill fast, beginning in March 2003.
2003 started off as an unusually warm spring. I was enjoying life and by the end of March, I had a beautiful tan from working outdoors in my garden.
Around this time, I noticed unusually large welts, the size of a silver dollar from mosquito bites. I also began to notice that my hair was thinning for no apparent reason and I began to have short emotional outbursts. I had sought help earlier for this, so my dosage of Prozac was increased and I was also prescribed anti-anxiety medication.
By mid-summer, I was experiencing short-term memory loss; my long-term memory was fine. I could remember something from twenty years ago, but nothing from 2 weeks ago. I'd make a mental list of groceries I needed, but when it was time to go to the store I couldn't remember anything on the list. At that time, I did not know that I had HIV Encephalitis, which would have explained my short-term memory loss.
My increasingly unreliable memory gave me insight and appreciation for what Alzheimer's sufferers must experience. I experienced all of the above symptoms every day, as well as chronic fatigue, which I didn't think too much of at the time because I couldn't remember a time when I wasn't extremely fatigued.
By September 2003 however, things took a turn for the worse. I started to have nausea, vomiting, diarrhea and accidents in the house and in public. I lost ten pounds and spent most of the day on the couch. I didn't
have any energy, nor did I feel like doing much. I was worn out and wanted desperately to improve my health, so I saw over ten doctors and every one of those ten doctors sent me for further blood tests. I was diagnosed with anaemia and given iron pills, but I continued to go downhill.
In November 2003 my current doctor ran more tests for antibodies to Hep C. He diagnosed Epstein Barr Virus and prescribed Promethazine for my nausea, but nothing improved my health, and my blood tests were still really abnormal. I was told to see an oncologist as soon as possible.
Later that month the oncologist gave me a bone biopsy test, where the patient is placed on their back and given an anaesthetic at the biopsy site. Next, a long tool is screwed through the skin into bone.
The biopsy specimen was inadequate so another sample was taken in a different location-this particular procedure was the worst that I've ever experienced. The biopsy showed severe immune depression, and finally, the doctor gave me an HIV Antibody Test, which came back positive.
At this point in time, I was relieved because I just wanted to know what was wrong with me.
The oncologist who diagnosed my HIV sent me home with only a referral to an Infectious Disease Specialist. I wasn't given any information or told of any treatment options, and I couldn't get in to see the specialist for 2 months. I had just been diagnosed HIV positive, but actually had full-blown AIDS. For two months I had no doctor, treatment options or support
from mainstream medicine. I?d developed a new symptom ? unsteady gait ? and I was alone and felt abandoned by the system.
However, having beaten one incurable disease, I was determined to beat another, so I searched for some inner strength, and resolved to do something positive and constructive. The alternative doctor gave me some supplements and treated me with chelation treatments. These treatments helped my quality of life tremendously. I could actually get off the couch and move around a bit.
By the time I reached the infectious disease specialist in January 2004, I was half-dead with CD4's at 78 and viral load greater than 100,000.
Around this time the pharmacist from the infectious disease visit reviewed my meds and unbeknown to me, the drug promethazine (prescribed Dec 2003 for nausea) had been causing my unsteady gait and stumbling. I stopped this medication and the problem resolved.
Frustratingly, the medications caused many of the symptoms I'd had in the first place such as, anemia, abnormal blood work and diarrhea. Because these medicines are linked to heart, liver, kidney failure, neuropathy and disfigurement, I was very concerned.
In early 2005, I stumbled upon information about an obscure treatment called Low Dose Naltrexone (LDN). There's so much information about treatment options on the Internet, so this too sounded too good to be true. I always believed in natural treatment methods and had an open mind to new treatment methods, so I researched more and read as much as I could find before taking my info with me to discuss with my infectious disease doctors.
I usually bombarded my doctors and my local pharmacist with information about supplements and treatment methods from the internet. However, they were not familiar with this drug, and weren't interested at all. So I pressed on.
A year later I saw an environmental physician, and he thought I should go on LDN. Wow, was I surprised and happy!
He prescribed LDN at the end of January 2006 and I immediately ordered it from Skip's Pharmacy. After reading about LDN on the lowdosenaltrexone.org website and learning about the great successes with this drug, on 1 Mar 2006 I stopped all other medicines and took only the LDN, much to the dismay of my doctors and my husband. I felt it was the right thing to do, no matter who supported me. I did so well on LDN that my husband has since changed his mind and my infectious disease doctors still follow me in amazement.
Finally, in September 2007, I was diagnosed with fibromyalgia, although I feel I?d had it since the 1970's.
It is now October 2007 and I have been on LDN for a total of 21 months. My blood and liver enzymes have been tested every 3 months since being diagnosed with AIDS. Approximately 6 months after being on LDN, my blood-work and liver enzymes reverted to normal and have been so ever since. I am no longer anaemic.
I still have heavy metals, mercury and lead in my body so my dental fillings are being replaced and chelation therapy is underway and being supervised by my environmental physician.
Although my viral load is high, I haven't had one opportunistic infection or even a cold while on LDN. OI is what kills AIDS patients due to a weakened immune system. LDN is definitely helping to keep the OIs at bay and maintaining my health. My quality of life is so much better now. I was couch-bound, sick and dying and now I can reach for the stars!
LDN has been a miracle drug for me, and I know that it is also working for others and saving so many lives! My sincere thanks go to Dr. Zagon and Dr. Bihari, and of course to all those who continue to spread the word because they've brought this miracle drug to us
Page 1 of 1
LDN - HIV - My Story
MultiQuote
#2
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- Group: Members
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- Joined: 05-July 06
Posted 27 October 2008 - 04:51 PM
LDNResearchTrust_admin, on Jan 10 2008, 11:03 AM, said:
Noreen Martin
In 1975, I had hepatitis due to working in the dental field at a time when protective measures were not in place. I was in hospital under observation for a week and convalesced for another 3 weeks. I was diagnosed with cancer and had cancer treatment in December of 1979.
Around April 2002, my left ear was buzzing and I could not hear much in that ear for one month. I was placed on the antibiotic Cipro and had an immediate reaction to it. It looked like I had the measles from head to toe, so this was changed to Keflex for two weeks.
In July 2002 I was diagnosed with a herniated disc and pinched nerves. This story relates to a period of deteriorating health, which went downhill fast, beginning in March 2003.
2003 started off as an unusually warm spring. I was enjoying life and by the end of March, I had a beautiful tan from working outdoors in my garden.
Around this time, I noticed unusually large welts, the size of a silver dollar from mosquito bites. I also began to notice that my hair was thinning for no apparent reason and I began to have short emotional outbursts. I had sought help earlier for this, so my dosage of Prozac was increased and I was also prescribed anti-anxiety medication.
By mid-summer, I was experiencing short-term memory loss; my long-term memory was fine. I could remember something from twenty years ago, but nothing from 2 weeks ago. I'd make a mental list of groceries I needed, but when it was time to go to the store I couldn't remember anything on the list. At that time, I did not know that I had HIV Encephalitis, which would have explained my short-term memory loss.
My increasingly unreliable memory gave me insight and appreciation for what Alzheimer's sufferers must experience. I experienced all of the above symptoms every day, as well as chronic fatigue, which I didn't think too much of at the time because I couldn't remember a time when I wasn't extremely fatigued.
By September 2003 however, things took a turn for the worse. I started to have nausea, vomiting, diarrhea and accidents in the house and in public. I lost ten pounds and spent most of the day on the couch. I didn't
have any energy, nor did I feel like doing much. I was worn out and wanted desperately to improve my health, so I saw over ten doctors and every one of those ten doctors sent me for further blood tests. I was diagnosed with anaemia and given iron pills, but I continued to go downhill.
In November 2003 my current doctor ran more tests for antibodies to Hep C. He diagnosed Epstein Barr Virus and prescribed Promethazine for my nausea, but nothing improved my health, and my blood tests were still really abnormal. I was told to see an oncologist as soon as possible.
Later that month the oncologist gave me a bone biopsy test, where the patient is placed on their back and given an anaesthetic at the biopsy site. Next, a long tool is screwed through the skin into bone.
The biopsy specimen was inadequate so another sample was taken in a different location-this particular procedure was the worst that I've ever experienced. The biopsy showed severe immune depression, and finally, the doctor gave me an HIV Antibody Test, which came back positive.
At this point in time, I was relieved because I just wanted to know what was wrong with me.
The oncologist who diagnosed my HIV sent me home with only a referral to an Infectious Disease Specialist. I wasn't given any information or told of any treatment options, and I couldn't get in to see the specialist for 2 months. I had just been diagnosed HIV positive, but actually had full-blown AIDS. For two months I had no doctor, treatment options or support
from mainstream medicine. I?d developed a new symptom ? unsteady gait ? and I was alone and felt abandoned by the system.
However, having beaten one incurable disease, I was determined to beat another, so I searched for some inner strength, and resolved to do something positive and constructive. The alternative doctor gave me some supplements and treated me with chelation treatments. These treatments helped my quality of life tremendously. I could actually get off the couch and move around a bit.
By the time I reached the infectious disease specialist in January 2004, I was half-dead with CD4's at 78 and viral load greater than 100,000.
Around this time the pharmacist from the infectious disease visit reviewed my meds and unbeknown to me, the drug promethazine (prescribed Dec 2003 for nausea) had been causing my unsteady gait and stumbling. I stopped this medication and the problem resolved.
Frustratingly, the medications caused many of the symptoms I'd had in the first place such as, anemia, abnormal blood work and diarrhea. Because these medicines are linked to heart, liver, kidney failure, neuropathy and disfigurement, I was very concerned.
In early 2005, I stumbled upon information about an obscure treatment called Low Dose Naltrexone (LDN). There's so much information about treatment options on the Internet, so this too sounded too good to be true. I always believed in natural treatment methods and had an open mind to new treatment methods, so I researched more and read as much as I could find before taking my info with me to discuss with my infectious disease doctors.
I usually bombarded my doctors and my local pharmacist with information about supplements and treatment methods from the internet. However, they were not familiar with this drug, and weren't interested at all. So I pressed on.
A year later I saw an environmental physician, and he thought I should go on LDN. Wow, was I surprised and happy!
He prescribed LDN at the end of January 2006 and I immediately ordered it from Skip's Pharmacy. After reading about LDN on the lowdosenaltrexone.org website and learning about the great successes with this drug, on 1 Mar 2006 I stopped all other medicines and took only the LDN, much to the dismay of my doctors and my husband. I felt it was the right thing to do, no matter who supported me. I did so well on LDN that my husband has since changed his mind and my infectious disease doctors still follow me in amazement.
Finally, in September 2007, I was diagnosed with fibromyalgia, although I feel I?d had it since the 1970's.
It is now October 2007 and I have been on LDN for a total of 21 months. My blood and liver enzymes have been tested every 3 months since being diagnosed with AIDS. Approximately 6 months after being on LDN, my blood-work and liver enzymes reverted to normal and have been so ever since. I am no longer anaemic.
I still have heavy metals, mercury and lead in my body so my dental fillings are being replaced and chelation therapy is underway and being supervised by my environmental physician.
Although my viral load is high, I haven't had one opportunistic infection or even a cold while on LDN. OI is what kills AIDS patients due to a weakened immune system. LDN is definitely helping to keep the OIs at bay and maintaining my health. My quality of life is so much better now. I was couch-bound, sick and dying and now I can reach for the stars!
LDN has been a miracle drug for me, and I know that it is also working for others and saving so many lives! My sincere thanks go to Dr. Zagon and Dr. Bihari, and of course to all those who continue to spread the word because they've brought this miracle drug to us
In 1975, I had hepatitis due to working in the dental field at a time when protective measures were not in place. I was in hospital under observation for a week and convalesced for another 3 weeks. I was diagnosed with cancer and had cancer treatment in December of 1979.
Around April 2002, my left ear was buzzing and I could not hear much in that ear for one month. I was placed on the antibiotic Cipro and had an immediate reaction to it. It looked like I had the measles from head to toe, so this was changed to Keflex for two weeks.
In July 2002 I was diagnosed with a herniated disc and pinched nerves. This story relates to a period of deteriorating health, which went downhill fast, beginning in March 2003.
2003 started off as an unusually warm spring. I was enjoying life and by the end of March, I had a beautiful tan from working outdoors in my garden.
Around this time, I noticed unusually large welts, the size of a silver dollar from mosquito bites. I also began to notice that my hair was thinning for no apparent reason and I began to have short emotional outbursts. I had sought help earlier for this, so my dosage of Prozac was increased and I was also prescribed anti-anxiety medication.
By mid-summer, I was experiencing short-term memory loss; my long-term memory was fine. I could remember something from twenty years ago, but nothing from 2 weeks ago. I'd make a mental list of groceries I needed, but when it was time to go to the store I couldn't remember anything on the list. At that time, I did not know that I had HIV Encephalitis, which would have explained my short-term memory loss.
My increasingly unreliable memory gave me insight and appreciation for what Alzheimer's sufferers must experience. I experienced all of the above symptoms every day, as well as chronic fatigue, which I didn't think too much of at the time because I couldn't remember a time when I wasn't extremely fatigued.
By September 2003 however, things took a turn for the worse. I started to have nausea, vomiting, diarrhea and accidents in the house and in public. I lost ten pounds and spent most of the day on the couch. I didn't
have any energy, nor did I feel like doing much. I was worn out and wanted desperately to improve my health, so I saw over ten doctors and every one of those ten doctors sent me for further blood tests. I was diagnosed with anaemia and given iron pills, but I continued to go downhill.
In November 2003 my current doctor ran more tests for antibodies to Hep C. He diagnosed Epstein Barr Virus and prescribed Promethazine for my nausea, but nothing improved my health, and my blood tests were still really abnormal. I was told to see an oncologist as soon as possible.
Later that month the oncologist gave me a bone biopsy test, where the patient is placed on their back and given an anaesthetic at the biopsy site. Next, a long tool is screwed through the skin into bone.
The biopsy specimen was inadequate so another sample was taken in a different location-this particular procedure was the worst that I've ever experienced. The biopsy showed severe immune depression, and finally, the doctor gave me an HIV Antibody Test, which came back positive.
At this point in time, I was relieved because I just wanted to know what was wrong with me.
The oncologist who diagnosed my HIV sent me home with only a referral to an Infectious Disease Specialist. I wasn't given any information or told of any treatment options, and I couldn't get in to see the specialist for 2 months. I had just been diagnosed HIV positive, but actually had full-blown AIDS. For two months I had no doctor, treatment options or support
from mainstream medicine. I?d developed a new symptom ? unsteady gait ? and I was alone and felt abandoned by the system.
However, having beaten one incurable disease, I was determined to beat another, so I searched for some inner strength, and resolved to do something positive and constructive. The alternative doctor gave me some supplements and treated me with chelation treatments. These treatments helped my quality of life tremendously. I could actually get off the couch and move around a bit.
By the time I reached the infectious disease specialist in January 2004, I was half-dead with CD4's at 78 and viral load greater than 100,000.
Around this time the pharmacist from the infectious disease visit reviewed my meds and unbeknown to me, the drug promethazine (prescribed Dec 2003 for nausea) had been causing my unsteady gait and stumbling. I stopped this medication and the problem resolved.
Frustratingly, the medications caused many of the symptoms I'd had in the first place such as, anemia, abnormal blood work and diarrhea. Because these medicines are linked to heart, liver, kidney failure, neuropathy and disfigurement, I was very concerned.
In early 2005, I stumbled upon information about an obscure treatment called Low Dose Naltrexone (LDN). There's so much information about treatment options on the Internet, so this too sounded too good to be true. I always believed in natural treatment methods and had an open mind to new treatment methods, so I researched more and read as much as I could find before taking my info with me to discuss with my infectious disease doctors.
I usually bombarded my doctors and my local pharmacist with information about supplements and treatment methods from the internet. However, they were not familiar with this drug, and weren't interested at all. So I pressed on.
A year later I saw an environmental physician, and he thought I should go on LDN. Wow, was I surprised and happy!
He prescribed LDN at the end of January 2006 and I immediately ordered it from Skip's Pharmacy. After reading about LDN on the lowdosenaltrexone.org website and learning about the great successes with this drug, on 1 Mar 2006 I stopped all other medicines and took only the LDN, much to the dismay of my doctors and my husband. I felt it was the right thing to do, no matter who supported me. I did so well on LDN that my husband has since changed his mind and my infectious disease doctors still follow me in amazement.
Finally, in September 2007, I was diagnosed with fibromyalgia, although I feel I?d had it since the 1970's.
It is now October 2007 and I have been on LDN for a total of 21 months. My blood and liver enzymes have been tested every 3 months since being diagnosed with AIDS. Approximately 6 months after being on LDN, my blood-work and liver enzymes reverted to normal and have been so ever since. I am no longer anaemic.
I still have heavy metals, mercury and lead in my body so my dental fillings are being replaced and chelation therapy is underway and being supervised by my environmental physician.
Although my viral load is high, I haven't had one opportunistic infection or even a cold while on LDN. OI is what kills AIDS patients due to a weakened immune system. LDN is definitely helping to keep the OIs at bay and maintaining my health. My quality of life is so much better now. I was couch-bound, sick and dying and now I can reach for the stars!
LDN has been a miracle drug for me, and I know that it is also working for others and saving so many lives! My sincere thanks go to Dr. Zagon and Dr. Bihari, and of course to all those who continue to spread the word because they've brought this miracle drug to us
Whilst this is an incredibly positive story of the success you can have with alternative treatments, I felt I should add a small addendum for any other people with HIV.
Many doctors would be concerned about using LDN along with the standard orthodox treatment for HIV - this is because "Naltrexone" has been shown to cause adverse effects in the liver when taken at the full 50-100mg dosage.
Because of the very low dose of naltrexone in LDN - the effects on the liver are almost negligable in most people, and we do not even recommend that people have liver enzyme tests done when starting LDN.
It is important to stress to everyone that LDN would generally be used as an adjunt to standard therapy - and will work together with the most regimes, with no increased side effects.
I must stress that it is generally a very bad idea to stop all standard treatment for such a life threatening disease - especially when there is extremely good evidence for how well it works at reducing viral load.
If you are considering LDN as a treatment for HIV, it can be taken as well as your current regimen.
#3
- Newbie
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- Group: Members
- Posts: 4
- Joined: 30-January 09
Posted 26 July 2009 - 04:47 AM
J Dickson MRPharmS, on 27 October 2008 - 09:51 AM, said:
Whilst this is an incredibly positive story of the success you can have with alternative treatments, I felt I should add a small addendum for any other people with HIV.
Many doctors would be concerned about using LDN along with the standard orthodox treatment for HIV - this is because "Naltrexone" has been shown to cause adverse effects in the liver when taken at the full 50-100mg dosage.
Because of the very low dose of naltrexone in LDN - the effects on the liver are almost negligable in most people, and we do not even recommend that people have liver enzyme tests done when starting LDN.
It is important to stress to everyone that LDN would generally be used as an adjunt to standard therapy - and will work together with the most regimes, with no increased side effects.
I must stress that it is generally a very bad idea to stop all standard treatment for such a life threatening disease - especially when there is extremely good evidence for how well it works at reducing viral load.
If you are considering LDN as a treatment for HIV, it can be taken as well as your current regimen.
Many doctors would be concerned about using LDN along with the standard orthodox treatment for HIV - this is because "Naltrexone" has been shown to cause adverse effects in the liver when taken at the full 50-100mg dosage.
Because of the very low dose of naltrexone in LDN - the effects on the liver are almost negligable in most people, and we do not even recommend that people have liver enzyme tests done when starting LDN.
It is important to stress to everyone that LDN would generally be used as an adjunt to standard therapy - and will work together with the most regimes, with no increased side effects.
I must stress that it is generally a very bad idea to stop all standard treatment for such a life threatening disease - especially when there is extremely good evidence for how well it works at reducing viral load.
If you are considering LDN as a treatment for HIV, it can be taken as well as your current regimen.
#4
- Newbie
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- Group: Members
- Posts: 4
- Joined: 30-January 09
Posted 26 July 2009 - 04:50 AM
The FDA Warning for liver when taking very large doses (300 mg) of Naltrexone
& Clinical Trials about its safety in the liver
Unfortunately, the FDA Naltrexone ‘black box’ warning about the possibility of liver issues can be very misleading when investigating Naltrexone or Low Dose Naltrexone because it does not provide the scope or dosage on which the warning is based. The below is information about the Black Box warning – it is based on a clinical study where patients were taking extremely high dosages of Naltrexone (300 mg a day) and a sub-set of obese patients developed some liver anomalies. Additionally, included below are 4 subsequent National Institutes of Health / National Library of Medicine Clinical Studies or Articles that specifically discuss the safety of Naltrexone to the liver, when used below 300 mg a day.
Therefore, according to the below studies, the dosages of Low Dose Naltrexone (LDN), which are a very small fraction of either a regular or high dosage of Naltrexone, could be presumed to have no negative affect of the liver. Note: The normal LDN dosage for adults is 4.5 mg or less per day, which is 1/66th of the maximum safe dosage level. For children the normal dose is between 1 mg (1/300th of the maximum safe dosage) to 3 mg (1/100th of the maximum safe dosage).
Also, the immune modulating affect of the opioid antagonist, Naltrexone, have been shown to improve the liver’s condition, including reducing ALT/AST levels, cholestasis-induced liver injury, liver fibrosis, and hepatitis. Those clinical trails will be posted separately under the “Files” Yahoo Group Section (under the “Treatment-Low Dose Naltrexone” Folder).
The following is an excerpt from the National Institutes of Health/National Library of Medicine/Daily Med Website (http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=4682)
“Evidence of the hepatotoxic potential of naltrexone is derived primarily from a placebo controlled study in which naltrexone hydrochloride was administered to obese subjects at a dose approximately five-fold that recommended for the blockade of opiate receptors (300 mg per day)..”
The below four (4) clinical studies are quoted from the National Institutes of Health / National Library of Medicine/Pub Med Website: (http://www.ncbi.nlm.nih.gov/sites/entrez?db=pubmed).
Study 1 –
Study of hepatotoxicity of naltrexone in the treatment of alcoholism.
Alcohol. 2006 Feb;38(2):117-20. Links
Yen MH, Ko HC, Tang FI, Lu RB, Hong JS.
Department of Pharmacology, National Defense Medical Center, Taipei, Taiwan.
Since a black box warning was issued by the Food and Drug Administration regarding the use of the opiate antagonist naltrexone (NTX), many clinicians have been concerned about current labeling of the potential hepatotoxicity risk of NTX in the treatment of opiate dependence and alcoholism. Despite many reports that demonstrated that the use of NTX did not cause elevation of liver enzymes, controversy concerning whether NTX is hepatotoxic continues. The current study monitored 74 alcoholic patients who received 25mg of NTX daily in the first week and then 50mg of NTX daily for the rest of the 12-week period. After the 12-week treatment, levels of the hepatic enzymes alanine aminotransferase (ALT) and aspartate aminotransferase (AST) did not show any elevation, except in one subject, and the results strongly support that NTX did not induce abnormalities in liver function tests or elevate the liver enzymes. Instead, a statistical significance of decreasing levels of ALT and AST in the liver was shown throughout the study. These findings provide further support that NTX is not hepatotoxic at the recommended daily dose and may be beneficial for patients with elevated liver enzymes.
PMID: 16839858 [PubMed - indexed for MEDLINE]
Study 2 -
High-dose naltrexone and liver function safety.
Am J Addict. 1997 Winter;6(1):21-9.Links
Marrazzi MA, Wroblewski JM, Kinzie J, Luby ED.
Department of Psychiatry, Harper-Grace Hospitals, Detroit, MI, USA.
Studies have found naltrexone useful in the treatment of diseases other than opiate addiction in which endogenous opioids presumably play a role, such as alcoholism and eating disorders. Some of these studies involve high doses (100-200 mg bid). Because investigational studies with high doses (300 mg/day) reported clinically significant increases in liver enzyme levels, the authors measured a spectrum of liver function parameters in response to high doses of naltrexone in a double-blind, crossover trial (100 mg bid) followed by an open-label period (200 mg bid). They observed no adverse clinical or laboratory changes in liver function in association with high-dose naltrexone therapy in eating disorders.
PMID: 9097868 [PubMed - indexed for MEDLINE]
Study 3 -
Naltrexone: report of lack of hepatotoxicity in acute viral hepatitis, with a review of the literature.
Addict Biol. 2004 Mar;9(1):81-7. Links
Brewer C, Wong VS.
The Stapleford Centre, London, UK. cbrewer@doctors.net.uk
Many clinicians appear to be concerned about the potential hepatotoxicity of the opiate antagonist naltrexone (NTX) and this may be one reason why it is not used more widely in treating both heroin and alcohol abusers. Some much-quoted early studies noted abnormalities in liver function tests (LFTs) in very obese patients taking high doses, although there was no evidence of clinically significant liver dysfunction. These concerns may be reinforced by advice in the UK product information sheet to perform LFTs before and during treatment, by high infection rates with hepatitis C virus (HCV) among injecting heroin addicts and by the frequency of abnormal LFTs in alcohol abusers. We describe a heroin abuser in whom clinical and laboratory manifestations of acute hepatitis B and C appeared a few days after the insertion of a subcutaneous naltrexone implant. A decision was made not to remove the implant but the hepatitis resolved completely and uneventfully well within the normal time-scale. A review of the literature indicates that even when given at much higher doses than are needed for treating heroin or alcohol abusers, there is no evidence that NTX causes clinically significant liver disease or exacerbates, even at high doses, serious pre-existing liver disease. During the past decade, NTX has been shown to be safe and effective in the treatment of pruritus associated with severe jaundice caused by severe and sometimes life-threatening cirrhosis and other liver diseases. Its safety, even in these extreme conditions, is particularly reassuring. We suggest that it may be more appropriate and economical to advise patients to report promptly any suspected side effects than to perform regular LFTs, which may be misleading.
PMID: 15203443 [PubMed - indexed for MEDLINE]
Study 4 -
Safety of high-dose naltrexone treatment: hepatic transaminase profiles among outpatients.
Clin Neuropharmacol. 2006 Mar-Apr;29(2):77-9. Links
Kim SW, Grant JE, Yoon G, Williams KA, Remmel RP.
Department of Psychiatry, Medical School, University of Minnesota, Minneapolis, 55454-1495, USA. kimxx003@umn.edu
OBJECTIVES: This study was carried out to test the hypothesis that the hepatic safety profile of prolonged high-dose oral naltrexone (150 mg/d) is acceptable if over-the-counter analgesic use is restricted.
METHODS: Data from 41 consecutive outpatients with impulse-control disorder receiving naltrexone therapy were analyzed.
RESULTS: The mean treatment duration was 328 days and the mean naltrexone dose was 142 mg/d. Pretherapy/posttherapy mean aspartate transaminase and alanine transaminase levels in the naltrexone-alone group were 21.79/22.54 and 21.74/21.49 U, respectively (all within reference range).
CONCLUSIONS: Although limited in scope, these findings support the hypothesis that long-term use of high-dose oral naltrexone is safe in otherwise healthy patients with impulse-control disorders who restrict their intake of acetaminophen, aspirin, or nonaspirin nonsteroidal anti-inflammatory drugs (NSAID). However, confirming studies are needed.
PMID: 16614539 [PubMed - indexed for MEDLINE]
Thanks to Hope4Joyce for the illuminating the topic...
Note regarding National Institutes of Health / National Library of Medicine Copyright / Public Domain information - quoted from (http://www.nlm.nih.gov/copyright.html).
NLM Copyright Information
Government information at NLM Web sites is in the public domain. Public domain information may be freely distributed and copied, but it is requested that in any subsequent use the National Library of Medicine (NLM) be given appropriate acknowledgement. When using NLM Web sites, you may encounter documents, illustrations, photographs, or other information resources contributed or licensed by private individuals, companies, or organizations that may be protected by U.S. and foreign copyright laws. Transmission or reproduction of protected items beyond that allowed by fair use (PDF) as defined in the copyright laws requires the written permission of the copyright owners. Specific NLM Web sites containing protected information provide additional notification of conditions associated with its use.
& Clinical Trials about its safety in the liver
Unfortunately, the FDA Naltrexone ‘black box’ warning about the possibility of liver issues can be very misleading when investigating Naltrexone or Low Dose Naltrexone because it does not provide the scope or dosage on which the warning is based. The below is information about the Black Box warning – it is based on a clinical study where patients were taking extremely high dosages of Naltrexone (300 mg a day) and a sub-set of obese patients developed some liver anomalies. Additionally, included below are 4 subsequent National Institutes of Health / National Library of Medicine Clinical Studies or Articles that specifically discuss the safety of Naltrexone to the liver, when used below 300 mg a day.
Therefore, according to the below studies, the dosages of Low Dose Naltrexone (LDN), which are a very small fraction of either a regular or high dosage of Naltrexone, could be presumed to have no negative affect of the liver. Note: The normal LDN dosage for adults is 4.5 mg or less per day, which is 1/66th of the maximum safe dosage level. For children the normal dose is between 1 mg (1/300th of the maximum safe dosage) to 3 mg (1/100th of the maximum safe dosage).
Also, the immune modulating affect of the opioid antagonist, Naltrexone, have been shown to improve the liver’s condition, including reducing ALT/AST levels, cholestasis-induced liver injury, liver fibrosis, and hepatitis. Those clinical trails will be posted separately under the “Files” Yahoo Group Section (under the “Treatment-Low Dose Naltrexone” Folder).
The following is an excerpt from the National Institutes of Health/National Library of Medicine/Daily Med Website (http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=4682)
“Evidence of the hepatotoxic potential of naltrexone is derived primarily from a placebo controlled study in which naltrexone hydrochloride was administered to obese subjects at a dose approximately five-fold that recommended for the blockade of opiate receptors (300 mg per day)..”
The below four (4) clinical studies are quoted from the National Institutes of Health / National Library of Medicine/Pub Med Website: (http://www.ncbi.nlm.nih.gov/sites/entrez?db=pubmed).
Study 1 –
Study of hepatotoxicity of naltrexone in the treatment of alcoholism.
Alcohol. 2006 Feb;38(2):117-20. Links
Yen MH, Ko HC, Tang FI, Lu RB, Hong JS.
Department of Pharmacology, National Defense Medical Center, Taipei, Taiwan.
Since a black box warning was issued by the Food and Drug Administration regarding the use of the opiate antagonist naltrexone (NTX), many clinicians have been concerned about current labeling of the potential hepatotoxicity risk of NTX in the treatment of opiate dependence and alcoholism. Despite many reports that demonstrated that the use of NTX did not cause elevation of liver enzymes, controversy concerning whether NTX is hepatotoxic continues. The current study monitored 74 alcoholic patients who received 25mg of NTX daily in the first week and then 50mg of NTX daily for the rest of the 12-week period. After the 12-week treatment, levels of the hepatic enzymes alanine aminotransferase (ALT) and aspartate aminotransferase (AST) did not show any elevation, except in one subject, and the results strongly support that NTX did not induce abnormalities in liver function tests or elevate the liver enzymes. Instead, a statistical significance of decreasing levels of ALT and AST in the liver was shown throughout the study. These findings provide further support that NTX is not hepatotoxic at the recommended daily dose and may be beneficial for patients with elevated liver enzymes.
PMID: 16839858 [PubMed - indexed for MEDLINE]
Study 2 -
High-dose naltrexone and liver function safety.
Am J Addict. 1997 Winter;6(1):21-9.Links
Marrazzi MA, Wroblewski JM, Kinzie J, Luby ED.
Department of Psychiatry, Harper-Grace Hospitals, Detroit, MI, USA.
Studies have found naltrexone useful in the treatment of diseases other than opiate addiction in which endogenous opioids presumably play a role, such as alcoholism and eating disorders. Some of these studies involve high doses (100-200 mg bid). Because investigational studies with high doses (300 mg/day) reported clinically significant increases in liver enzyme levels, the authors measured a spectrum of liver function parameters in response to high doses of naltrexone in a double-blind, crossover trial (100 mg bid) followed by an open-label period (200 mg bid). They observed no adverse clinical or laboratory changes in liver function in association with high-dose naltrexone therapy in eating disorders.
PMID: 9097868 [PubMed - indexed for MEDLINE]
Study 3 -
Naltrexone: report of lack of hepatotoxicity in acute viral hepatitis, with a review of the literature.
Addict Biol. 2004 Mar;9(1):81-7. Links
Brewer C, Wong VS.
The Stapleford Centre, London, UK. cbrewer@doctors.net.uk
Many clinicians appear to be concerned about the potential hepatotoxicity of the opiate antagonist naltrexone (NTX) and this may be one reason why it is not used more widely in treating both heroin and alcohol abusers. Some much-quoted early studies noted abnormalities in liver function tests (LFTs) in very obese patients taking high doses, although there was no evidence of clinically significant liver dysfunction. These concerns may be reinforced by advice in the UK product information sheet to perform LFTs before and during treatment, by high infection rates with hepatitis C virus (HCV) among injecting heroin addicts and by the frequency of abnormal LFTs in alcohol abusers. We describe a heroin abuser in whom clinical and laboratory manifestations of acute hepatitis B and C appeared a few days after the insertion of a subcutaneous naltrexone implant. A decision was made not to remove the implant but the hepatitis resolved completely and uneventfully well within the normal time-scale. A review of the literature indicates that even when given at much higher doses than are needed for treating heroin or alcohol abusers, there is no evidence that NTX causes clinically significant liver disease or exacerbates, even at high doses, serious pre-existing liver disease. During the past decade, NTX has been shown to be safe and effective in the treatment of pruritus associated with severe jaundice caused by severe and sometimes life-threatening cirrhosis and other liver diseases. Its safety, even in these extreme conditions, is particularly reassuring. We suggest that it may be more appropriate and economical to advise patients to report promptly any suspected side effects than to perform regular LFTs, which may be misleading.
PMID: 15203443 [PubMed - indexed for MEDLINE]
Study 4 -
Safety of high-dose naltrexone treatment: hepatic transaminase profiles among outpatients.
Clin Neuropharmacol. 2006 Mar-Apr;29(2):77-9. Links
Kim SW, Grant JE, Yoon G, Williams KA, Remmel RP.
Department of Psychiatry, Medical School, University of Minnesota, Minneapolis, 55454-1495, USA. kimxx003@umn.edu
OBJECTIVES: This study was carried out to test the hypothesis that the hepatic safety profile of prolonged high-dose oral naltrexone (150 mg/d) is acceptable if over-the-counter analgesic use is restricted.
METHODS: Data from 41 consecutive outpatients with impulse-control disorder receiving naltrexone therapy were analyzed.
RESULTS: The mean treatment duration was 328 days and the mean naltrexone dose was 142 mg/d. Pretherapy/posttherapy mean aspartate transaminase and alanine transaminase levels in the naltrexone-alone group were 21.79/22.54 and 21.74/21.49 U, respectively (all within reference range).
CONCLUSIONS: Although limited in scope, these findings support the hypothesis that long-term use of high-dose oral naltrexone is safe in otherwise healthy patients with impulse-control disorders who restrict their intake of acetaminophen, aspirin, or nonaspirin nonsteroidal anti-inflammatory drugs (NSAID). However, confirming studies are needed.
PMID: 16614539 [PubMed - indexed for MEDLINE]
Thanks to Hope4Joyce for the illuminating the topic...
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