FERRONYL® IRON

Safety & Toxicity Summary
The primary reason Ferronyl iron is offered as an alternative to ferrous salts is the inherent safety (30 - 150
fold reduction in toxicity) that results from the rate limiting conversion of elemental iron to ferrous ion via
gastric acid. As a result of the slow gastrointestinal oxidation, toxic effects resulting from accidental
overdose of carbonyl iron take longer to materialize; a window of time allowing clinical intervention. Both
historic and more recently expanded acute oral toxicity studies in several animal models support these
claims. In addition, statistics compiled by the American Association of Poison Control Centers show both
fewer and less severe incidences of toxic exposure resulting from accidental overdose of carbonyl iron
powder versus ferrous salts. This inherently safe material is one effective and demonstrable way iron
supplementation does not become iron overdose and death.
Poison Control Statistics
In statistics compiled through the American Association of Poison Control Centers' Toxic Exposure
Surveillance System (AAPCC TESS) carbonyl iron powder had substantially fewer and less severe signs and
symptoms of toxicity than ferrous salts both on an absolute basis and relative to the total number of
reported incidences (Table 6). Furthermore, the same AAPCC TESS database shows that carbonyl iron
powder is significantly safer than ibuprofen, a common over the counter drug not subject to the
packaging and labeling requirements of iron supplements. Another finding from these data is that the
AAPCC documented the length of time these overdose signs and symptoms persisted in the ferrous salt
and carbonyl iron powder overdose situations. With iron salt overdoses, the majority of the symptoms for
both moderate and severe effects lasted over 24 hours and some as long as one month. In the two
reported cases of carbonyl iron powder overdoses there was complete recovery within 8 hours.
Table 6. Carbonyl iron powder (CIP) caused fewer and less severe incidences of toxicity than ferrous
salts or ibuprofen.
Iron Salts
(1995)
Iron Salts
(1996)
Ibuprofen
(1995)
Ibuprofen
(1996)
CIP
(1995)
CIP
(1996)
Moderate Effect 155 117 17 29 1 1
Major Effect 14 5 1 2 0 0
Death 2 2 0 0 0 0
Total 171 124 18 31 1 1
Reported Exposures 21,643 22,382 18,333 21,970 1527 1252
>Moderate Effect 0.79% 0.55% 0.10% 0.14% 0.06% 0.08%
10