Someone PM'ed me a question, and in the process of composing a response, I happened to look up the "inactive" ingredients for Asacol HD. They are:
colloidal silicon dioxide, dibutyl phthalate, edible black ink, ferric oxide red, ferric oxide yellow, lactose monohydrate, magnesium stearate, methacrylic acid copolymer B (Eudragit S), methacrylic acid copolymer A (Eudragit L), polyethylene glycol, povidone, sodium starch glycolate, and talc
So, second to the sand, bidutyl phthalate is the second main inactive ingredient, and behind the ink, and rust, lactose monohydrate is the next most prominent ingredient. Hmmmmm.
DBP is a commonly used plasticizer. It's also used as an additive to adhesives or printing inks. It's soluble in various organic solvents, such as alcohol, ether and benzene, but presumably, as the capsule begins to break down in the small intestine, the DBP will also be "digested", so if you happen to be sensitive to it, I would suspect that it could be a problem, possibly a thorny problem.
DBP is banned from being used in cosmetics, including nail polishes, in the European Union, and it's banned in children's toys, and childcare articles, in concentrations of more than 1 part per thousand, (0.1%), in California. The problem is that it is a suspected endocrine disruptor.
Endocrine disruptors are substances which do not occur normally in the body, (exogenous substances, IOW), that interfere with the synthesis, secretion, transport, binding, action, or elimination of natural hormones in the body that are responsible for the maintenance of normal cell metabolism, (homeostasis), reproduction, development, and/or behavior. They're also sometimes referred to as hormonally active agents, endocrine disrupting chemicals, or endocrine disrupting compounds, (EDCs).
These are uncharted waters, (since I'm pretty sure that no scientific research has been done specifically on DBP's hormonal effects on the human body), but IMO, there is certainly the possibility that it could be causing the hormonal symptoms that a member who has been taking Asacol HD recently described, (if she happens to be sensitive to it), because her symptoms certainly appear to be hormonally-based.
I checked the ingredient list for most of the other 5-ASA meds, (specifically, Lialda, Apriso, Pentasa, and Colazal), and none of them appear to contain either of the two chemicals that I discussed above, nor any other ingredients that appear to be harmful.
Obviously, I can't say for sure that the DBP, (or lactose monohydrate), in the Asacol HD might cause hormonal issues for anyone, but the DBP, for sure, certainly looks suspicious. I'm amazed that they would use it in a medication designed to treat an IBD. It just illustrates the lack of plain old common sense among the chemists who develop the formulations for many of the pharmaceutical products that are intended to treat disease.
Anyway, FWIW, those are my thoughts on the matter, so if you choose to use Asacol Hd, please be aware of this possible issue. Regular Asacol does not contain the DBP, (though it does contain lactose - in fact, it's the main "inactive" ingredient). Only the HD formulation if Asacol, (IOW, the "improved" version
), contains DBP. I put the term "inactive" in quotation marks, because obviously, that's a misnomer, for most of us, since lactose, and any of it's derivatives, can cause quite a reaction - hardly what I would call "inactive". And as always, remember, I'm not a doctor - I'm just here to try to catch some of their mistakes.
Tex
