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

The nature of Crohn’s and Colitis is not known. I think this is one cause of patients using nonprescription drugs, often misnamed nutritional supplements. A reader of the IBDList asked my opinion of Salmon Oil after reading the article on this page regarding Purepa. My reply was really a discussionof these unregulated drugs, Concerns Regarding the Use of Nonprescription Drugs in Crohn’s and UC.

A reader asked:

Dear Dr. Holland:

As the mother of a 22-year old son with Crohn’s, I have valued your input on the IBDList for the past year. Today was my first visit to your IBD page.

In addition to being on Asacol, I have had my son on a variety of other natural “remedies” including cat’s claw, aloe vera capsules, vitamins and salmon oil.  After reading your article about Purepa, I am anxious for him to give it a try.  Do you feel this would have a greater benefit than the salmon oil capsules?  If so, do you know if it is yet available in the U.S. (the article you referred to was published in 1996).

Thank you in advance for this information. I appreciate everything you do to further the quest for a cure for Crohn’sand UC.

P.S.  My son is currently a patient at the Univ. of Iowa Hospitals (Center for Digestive Diseases). Do you feel they have an adequate “handle” on IBD? Are you taking new patients?

U of Iowa is well respected.  An important question in getting a handle on the case is to be sure they know your son is on a number of non-prescribed medications.  There is a misconception that many share that natural remedies are not medications.  Consider this:  A drug is a substance which is taken to affect a patient’s metabolism in some desireable way.  These natural products really are being used as medications by many.  The trouble doctors have in dealing with them is that there is in general no safety or efficacy data available to base any recommendation upon.  The drug companies that sell these materials have lobbied congress and have gotten laws passed that have prohibited regulation of themselves.  They also have a fig leaf of a regulation that 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 causing death in several children due to daily administration of certain herbal teas.  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 because something comes in pill form does not mean it is as safe as people have come 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.