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Facts about drug LDN for Autoimmune Disease and More

Posted in: Conditions
By Dr. Pantea Etminan, NHD
Jul 20, 2012 - 12:38:19 PM

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As it sounds, LDN has been approved by FDA in larger doses--but they seem to not be interested to do more research in smaller dosages, which has been shown to work on many patients with success. Of course, this is still a pharmaceutical drug, but one that seems to have much less issues and side effects than most other drugs in it's class which are usually prescribed and administered at much higher dose. This alone may be one factor why of its low side effects. Besides that, studying the drug effects and it's actions itself, it does make sense. It works on the endorphins and such hormones which are highly important to the balance of the system--and which are disturbed in autoimmune disease, cancer and other illnesses. It is given at certain times, which correlates with TCM and Natural Health philosophies and ideology that has been in works for centuries by now.

Over all, it sounds like an option that would be of lesser evil from pharmaceutical drug point. From it's efficacy, as it's shown--it could work, but of course, as everyone is an individual, each person may have different results. But, if one is going to try a pharmaceutical drug this does sound promising with much less concern. They are from DuPont, which I don't support, but then again, all pharmaceutical drugs are from some source similar that are not so much for helping people but their own profits. Again, we must keep in mind that there could be a balance and some good amongst these sources and companies--thus the drugs that they may offer. Specially if there are no other options at the time.

We must always keep in mind that optimal health and healing of the body does come from its balance and nature itself. Sometimes we may need to give it some boost or assistance from sources that may not be so much of nature but could help. Still, meanwhile it is best to continue with natural healing and allow the body to become stronger and more balanced so it can heal itself. The best way to obtain this would be to consult and work with a natural health practitioner who is knowledgeable in such areas. You would be amazed at the results.

Please do review and study what LDN is all about and if it is some thing that you may feel would be for you--you would want to discuss it with your doctor and proceed from there. Do not allow the fact that it is low dose (which certain doctors may not approve of) and not approved by FDA stand in the way. This drug has actually been approved by FDA already, just in larger doses.

IMPORTANT: Make sure to specify that you do NOT want LDN in a slow-release form.
Reports have been received from patients that their pharmacies have been supplying a slow-release form of naltrexone. Pharmacies should be instructed NOT to provide LDN in an "SR" or slow-release or timed-release form. Unless the low dose of naltrexone is in an unaltered form, which permits it to reach a prompt "spike" in the blood stream, its therapeutic effects may be inhibited.
Fillers. Capsules of LDN necessarily contain a substantial percentage of neutral inactive filler. Experiments by the compounding pharmacist, Dr. Skip Lenz, have demonstrated that the use of calcium carbonate as a filler will interfere with absorption of the LDN capsule. Therefore, it is suggested that calcium carbonate filler not be employed in compounding LDN capsules. He recommends either Avicel, lactose (if lactose intolerance is not a problem), or sucrose fillers as useful fast-release fillers.

IMPORTANT: Make sure to fill your Rx at a compounding pharmacy that has a reputation for consistent reliability in the quality of the LDN it delivers.

What dosage and frequency should my physician prescribe?

The usual adult dosage is 4.5mg taken once daily at night. Because of the rhythms of the body's production of master hormones, LDN is best taken between 9pm and 3am. Most patients take it at bedtime.

Are there any side effects or cautionary warnings?

Side effects:
LDN has virtually no side effects. Occasionally, during the first week's use of LDN, patients may complain of some difficulty sleeping. This rarely persists after the first week. Should it do so, dosage can be reduced from 4.5mg to 3mg nightly.

Cautionary warnings:
1. Because LDN blocks opioid receptors throughout the body for three or four hours, people using medicine that is an opioid agonist, i.e. narcotic medication - such as Ultram (tramadol), morphine, Percocet, Duragesic patch or codeine-containing medication - should not take LDN until such medicine is completely out of one's system. Patients who have become dependant on daily use of narcotic-containing pain medication may require 10 days to 2 weeks of slowly weaning off of such drugs entirely (while first substituting full doses of non-narcotic pain medications) before being able to begin LDN safely.
2. Those patients who are taking thyroid hormone replacement for a diagnosis of Hashimoto's thyroiditis with hypothyroidism ought to begin LDN at the lowest range (1.5mg for an adult). Be aware that LDN may lead to a prompt decrease in the autoimmune disorder, which then may require a rapid reduction in the dose of thyroid hormone replacement in order to avoid symptoms of hyperthyroidism.
3. Full-dose naltrexone (50mg) carries a cautionary warning against its use in those with liver disease. This warning was placed because of adverse liver effects that were found in experiments involving 300mg daily. The 50mg dose does not apparently produce impairment of liver function nor, of course, do the much smaller 3mg and 4.5mg doses.
4. People who have received organ transplants and who therefore are taking immunosuppressive medication on a permanent basis are cautioned against the use of LDN because it may act to counter the effect of those medications.

When will the low-dose use of naltrexone become FDA approved?

Although naltrexone itself is an FDA-approved drug, the varied uses of LDN still await application to the FDA after related scientific clinical trials.
The FDA approved naltrexone at the 50mg dosage in 1984. LDN (in the 3mg or 4.5mg dosage) has not yet been submitted for approval because the prospective clinical trials that are required for FDA approval need to be funded at the cost of many millions of dollars.

The successful results of the first US medical center research on LDN, an open-label trial that tested the use of LDN in Crohn's disease (details here), was presented in May 2006 by Professor Jill Smith of the Pennsylvania State University College of Medicine. The National Institutes of Health has granted $500,000 for Dr. Smith's group to continue the study as a larger placebo-controlled scientific trial of LDN in Crohn's disease.

All physicians understand that appropriate off-label use of an already FDA-approved medication such as naltrexone is perfectly ethical and legal. Because naltrexone itself has already passed animal toxicity studies, one could expect that once testing is able to begin, LDN could complete its clinical trials in humans and receive FDA approval for one or more uses within two to four years.

• Bernard Bihari, MD, was the discoverer of the major clinical effects of low dose naltrexone. A private practitioner in Manhattan, Dr. Bihari was a Board-certified specialist in Psychiatry and Neurology. Dr. Bihari's curriculum vitae.
• David Gluck, MD (NY Lic. #083512), is the editor of this website, He is a Board-certified specialist in both Internal Medicine and Preventive Medicine. Dr. Gluck has served as medical director for JCPenney and MetLife, and is now semi-retired, living and working in New York City. [Ed. Note: Please do not confuse David Gluck, MD with an unrelated doctor of similar name in New York, David A. Gluck, who is a specialist in Obstetrics and Gynecology.]
• Ian S. Zagon, PhD, has spent over two decades in doing basic research concerning endorphins. He is Professor of Neural and Behavioral Sciences, Pennsylvania State University, Dept. of Neural and Behavioral Sciences, H-109, Hershey Medical Center, Hershey, PA 17033; office phone: (717) 531-6409; email:; website.


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