Concerns Regarding the Use of Nonprescription Drugs in Crohn's and UC

A reader asked:

U of I is well respected.  An important question in gettinga handle on the case is to be sure they know your son is on a number ofnon-prescribed medications.  There is a misconception that many sharethat natural remedies are not medications.  Consider this:  Adrug is a substance which is taken to affect a patient's metabolism insome desireable way.  These natural products really are being usedas medications by many.  The trouble doctors have in dealing withthem is that there is in general no safety or efficacy data available tobase any recommendation upon.  The drug companies that sell thesematerials have lobbied congress and have gotten laws passed that have prohibitedregulation of themselves.  They also have a fig leaf of a regulationthat says as long as they just say the magic words "nutritional supplement"they can market to the public without any regulatory oversight.

There is another misconception that natural substances are safe. There are tragedies in the medical literature of liver failure causingdeath in several children due to daily administration of certain herbalteas.  The teas were known to be hepatotoxic, but the labelling didnot include this (didn't have to, it was a nutritional supplement). There are a number of natural substances that are known to be toxic insufficient doses.  Nicotine, caffeine, digitalis, aspirin, strychnine,castor oil, ipecac, poppy juice, to name a few.  (The last exampleis particularly instructive. Poppies are a source of opiates which causedwell documented toxicity to Dorothy, Toto, and the Cowardly Lion. The Tin Man and Scarecrow were spared, due to a difference in metabolism.) There are cases of death due to contaminated tryptophan.  Just becausesomething comes in pill form does not mean it is as safe as people havecome to expect from pills from regulated drug companies.

You may be aware that the risk of drug interactions goes up with thenumber of drugs taken.  With your son being on four different additionalmedications than prescribed there is the potential of drug interactions.

So, what are the drugs you are giving your child doing?  I don'tknow.  Indeed, I know that no one can know.  The products describedare all complex.  Aside from the vitamins, their manufacture is notregulated.  Fish oils can be a source of dioxins.  I wonder ifany of the nonprescription drugs your son is on have been through any regularmonitoring of known or likely contaminants.  The medical literaturealso contains articles showing that the unregulated drugs are sometimesmisidentified by the manufacturer.

I try to limit my advice to matters for which there is some sort ofexperience with the substance at hand which can predict how a patient willdo.  The need for the evidence to be predictive is what patients reallywant.  It is expected that a doctor could explain what the expectedeffect would be, what the side effects would be, and the chance of eitherhappening.  For the majority of unregulated drugs, the evidence forthe medicines marketed as nutritional supplements is anecdotal, which doesnot help one make predictions as to how a patient will respond.

All that said, what can I say about your particular questions?  Well, I do not have data on efficacy or side effects of Salmon oil in Crohn's. Thus, prediction of relative effects is not possible.  (I even donot know if Purepa is whole fish extract or part fish extract.  Asa licensed drug, processing must adhere to Italian good manufacturing practicesand will therefore be consistent lot to lot.)  I also do not knowwhat interactions would develop, if any, with the other medications heis on.  As to Purepa, note that the patients in the study were selectedwith criteria that predicted a high chance of relapse.  The singlestudy thus applies to patients with the same clinical features.  Itis probably generalizable to patients outside Italy, though the fact thatItalians eat more olive oil is one reason that studies in other countrieswould be good.  Whether the drug would be beneficial to patients witha lower risk of relapse is not known.

The simple answer, therefore, is "I do not know."  The reason forwriting all of the above is to explain the underlying concerns that I asa physician have that causes me to say "I do not know".  As a fellowprescriber of medications I urge you to consider the risks and benefitsof your recommendations.  Also, I hope that you are keeping recordsof clinical response and medications (including dose and regimen and lot/batchnumber).  These records would be valuable for determining likely candidatemedications relating to clinical response, good or bad.

I hope for the best in your son's case.

Stephen Holland, M.D.
Section of Clinical Pharmacology
University of Illinois College of Medicine at Peoria
Copyright 1999, Stephen Holland, M.D.

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