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Reliability Problem With
Compounding Pharmacies

In Brief

The FDA has found a significant error rate in compounded prescriptions for a wide number of drugs produced at randomly selected pharmacies. Dr. Bihari has reported patients with adverse effects from this problem.

Please see the list of recommended pharmacies on the LDN home page for some suggested sources.


Background

We have gradually become aware of the relative unreliability of many compounding pharmacies that make up LDN capsules, with regard to the accuracy of the capsules' content.

One dramatic example presented to Dr. Bihari recently in a family with three members who have multiple sclerosis. The first was a 49-year-old woman who had been receiving her LDN from a national mail order pharmacy affiliated with her health insurance company. After starting the LDN, her slowly progressive MS continued to worsen, most particularly in her leg functioning and in her general neurological exam. Her 30 year old son, who resides in a different part of New York City, began taking LDN 18 months ago because of mild spasticity, weakness in his legs and some numbness in his hands and feet. He has been receiving his LDN from Irmat Pharmacy in New York City and had complete symptom relief on it.

He recently stayed with his mother for three weeks when an unrelated illness prevented him from going to work. Since he had forgotten to bring his own LDN bottle, he started taking his mother's capsules. After three days, his old symptoms began to reappear. He went home briefly to pick up his own LDN, and the new symptoms cleared on it. His mother then started taking his LDN, and in two days she had a significant reduction in fatigue and spasticity. Dr. Bihari interviewed and examined both patients and switched the mother's source of LDN to Irmat.

Although this is the most clear-cut example, there have been several other patients with various diseases, who after not doing as well as they expected on LDN from another pharmacy, switched their LDN source.

One is a woman with non-Hodgkin's lymphoma who started LDN in June 2002, obtaining it from a local pharmacy in a southern city in which she resides. Over the following four months, her fatigue continued, her spleen continued to enlarge and she developed a new lemon-size mass in her neck. In view of this worsening, it was recommended that she switch her LDN source to Irmat and in the following eight weeks, with no other change in treatment, she experienced complete clearing of the mass on her neck, a noticeable reduction in the size of her spleen and a significant improvement in energy.

Supporting evidence for the relative unreliability of compounded drugs is available in an FDA study* of compounded drugs from 12 compounding pharmacies. According to the study: "Ten (34%) of the 29 sampled products failed one or more standard quality tests performed. Nine of the ten products with failing analytical results failed assay or potency testing." The lack of any regulatory monitoring of compounded drugs makes this possible.

At the moment, Dr. Bihari is using Irmat Pharmacy for his patients. We would be most interested in the names and phone numbers of any compounding pharmacies whose LDN has been significantly helpful to several patients, regardless of their diagnoses. We encourage patients with good results from such pharmacies to contact us via e-mail with the names, addresses and phone numbers of the originating pharmacies. Direct solicitation by pharmacies to be added to our website list would not be helpful—only useful information from patients is sought, particularly if there are several using the same pharmacy.

* Report: Limited FDA Survey of Compounded Drug Products