Why is Ferrazone® the preferred iron source to treat iron deficiency anemia???

Among the commonly used iron salts, Ferrazone® has several significant advantages. Ferrazone® is the preferred iron source to treat iron deficiency anemia because: (1) it has a higher absorption rate in the human body (2) it has no negative influence on the bioavailability of other minerals (3) it can be added unobtrusively to several food vehicles (4) it is stable under adverse storage and cooking conditions (5) it is highly bioavailable and is least affected by absorption inhibitors, especially in phytate-rich diets (6) it poses no risks of iron overload, and (7) it exhibits minimal gastrointestinal disturbances.

What is Ferrazone®?

Ferrazone® is Akzo Nobel’s brand name for sodium iron (III) ethylenediaminetetraacetate (NaFeEDTA). It is also commonly known as sodium feredetate.

What is the relative bioavailability (RBV) of Ferrazone® as compared to other iron sources?

Numerous iron absorption studies comparing the bioavailability of various iron sources and Ferrazone® (NaFeEDTA) have been conducted over the past several years. It is generally accepted that the RBV of Ferrazone® is 200~300. Ferrous sulfate, the commonly used iron salt, has an RBV of 100.

Has the efficiacy of Ferrazone® been tested on a large scale?

Several comprehensive population trials in Thailand, Guatemala, Vietnam, China and South Africa highlight the therapeutic efficacy of Ferrazone®. A daily dose as low as 5 mg Fe (as Ferrazone®) per person has been demonstrated to be effective in improving the iron status (Hb) above the cut off level within three months.

Is the latest safety data available on Ferrazone®?

A comprehensive study on the disposition, accumulation and toxicity of iron in rats was conducted by Appel et al. in 2000. They administered FeSO4 and FeNaEDTA in rats via the diet for 31 and 61 days. Clinical signs, body weights, food consumption, food conversion efficiency, hematology, clinical chemistry and pathology of selected organs were used as criteria for disclosing possible harmful effects. Iron is accumulated from the diet in liver, spleen and kidneys in a dose-dependent manner. Iron derived from FeNaEDTA was taken up and/or accumulated less efficiently in liver and spleen than iron from FeSO4. Moreover, feeding iron up to 11.5 and 11.2 mg/kg body weight/day, derived from FeSO4 and FeNaEDTA, respectively, did not result in tissue iron excess or in any other toxicologically significant effects.

How is Ferrazone® metabolized in the human body?

When Ferrazone® is ingested, it passes the stomach intact. Subsequently it arrives in the duodenum and small intestine, where the absorption into the blood circulation of iron and other minerals takes place. The mucosa cells that line the duodenum and small intestine possess the remarkable capability to split Ferrazone® into iron and EDTA molecule. The iron molecule is absorbed into the body, while EDTA molecule stays behind and is finally excreted via the stool. A small part (5%) of this split-off EDTA is able to enter the blood circulation, but is quantitatively excreted by the kidneys within 24 hours. Less than 1% of the sodium feredetate enters the blood circulation, but the kidneys quickly and completely remove it as well.

Since the body absorbs the iron in Fe2+ (ferrous) form, why a Fe3+ (ferric) form from Ferrazone® absorbable in the human body?

Under ambient conditions, most ferrous salts are soluble in water, whereas their ferric counterparts are not. Since iron bioavailability to a major extent is a function of solubility, ferrous salts rank among the most effective iron supplements known to-date. Likewise, it is known that the mucosa cells take up iron from the lumen as ferrous ions and not as ferric ions. Nevertheless, these very same cells can readily convert ferric ions into ferrous ions. Therefore, an effective iron source does not necessarily need to be in the ferrous form. It can be in the ferric form as well provided the ferric salt is sufficiently soluble in water.

What is the effect of Ferrazone® on taste, side-effect and effectiveness?

Iron compounds are usually associated with undesirable metallic taste and have been known to cause gastro-intestinal problems. To avoid the occurrence of metallic taste would require lowering the content of iron compound in the supplement. Unfortunately, this would render the supplement ineffective. Due to its remarkable bioavailability, Ferrazone® effectively eliminates the dilemma of effectiveness vs. bad taste and gastrointestinal side effects.

What is the regulatory status of Ferrazone®?

Ferrazone® is specified in British Pharmacopoeia 2001. It is officially recommended by JECFA in 1999 and is declared GRAS (Generally Recognized As Safe) in 2004.

How much does Ferrazone® cost?

The cost of iron fortification program with Ferrazone® is estimated at US$0.10 per person per year, which is comparable to the cost of Vitamin A and Iodine fortification programs.