Megamin

Digestibility

Extensive studies have been carried out on the synthetic zeolite A due to its use in consumer products. These studies have demonstrated that type A zeolite is essentially non-toxic via oral, dermal, ocular, and respiratory routes of exposure 15.

Clinoptilolite, the natural zeolite contained in Megamin, was studied thoroughly as well and according to the provider is non-toxic 7, 8 . But only preclinical toxicological research exists about TMAZ, which showed no harm to animals 8. Toxicological research in humans has not been performed; harm to humans cannot therefore be excluded.

Pharmacokinetics / pharmacodynamics

Regrettably, no data are available on the gastrointestinal resorption or oral bioavailability of TMAZ in humans. No clinical research on pharmacokinetic exists. There are several potential dangers that can be associated with TMAZ:

1. Ion exchangers containing zeolites are well known for being used as water softeners – this softening process is due to exchanging sodium for calcium. Because of the different ways sodium can bind to trace elements a deficiency of potassium, sodium, selenium, iron, calcium, magnesium etc could occur in humans, if there is no enteral absorption of the TMAZ-complex.

In the same way, trace elements like potassium, selenium, iron, calcium, magnesium etc could be exchanged for sodium (which is bound to TMAZ). If there is no enteral resorption of these formatted TMAZ-trace-element-complexes, the deficiencies of trace elements will result. Such deficiencies can cause diseases, e g anaemia (due to deficiency of iron) or hypocalcaemic hyperventilation (due to deficiency of calcium).

2. On the other hand, there are data that clinoptilolite can bind/remove ammonia or toxins, whereby it could possibly have a positive effect, for instance, in liver diseases 16,17. But for that reason interactions with (orally taken) medicine or drugs are plausible by binding, catalysis or ion exchange catalyzed by TMAZ. This again causes reduced effects of the respective drug/medicine.

3. In contrast to this, if there should be any considerable resorption of TMAZ bound with calcium, calcification of blood vessels (with consecutive diseases like arteriosclerosis, coronary heart disease, occlusive arterial diseases etc.) or homeostasis disorder (hypercalcaemia) is possible, because the exchange process is reversible 18.

Carcinogenetic / teratogenitic effects

Data exist that clinoptilolite exhibits carcinogenic activity if it is inhaled 19, 20, although there are preclinical suggestions disproving this 11. No long-term observations exist. Furthermore, there are no reliable data available about TMAZ use during pregnancy or breastfeeding. Pavelic reported a decreased pup’s weight and consequently a higher mortality of pups of mice treated with TMAZ during pregnancy. The author points to an increased number of pups per litter as the reason for this 8.