Table 1 USFDA-approval commercial IONPs

Trade name

Feridex I.V

(USA)

Endorem

(EU)

Lumirem

(USA)

GastroMARK

(EU)

Feraheme

(USA) Rienso

(EU)

Approval date

USFDA approval in 1996

Discontinued in 2008

USFDA approval in 1996

Discontinued in 2012

USFDA approval in 2009

Coating

Dextran

Siloxane

Carboxymethyl-dextran

Size

120–180 nm

300 nm

20–50 nm

Blood half-life

10 min

NA

14 h

Recommended dose

30 μmol Fe kg⁻¹

600 mL (105 mg Fe)

An initial 510 mg dose followed by a second 510 mg dose 3 to 8 days later

Administration route

Intravenously

Oral suspension

Intravenously

Application/indication

Visualization of liver tumors and metastasis

Contrast enhancement agent for MRI of gastrointestinal and examination of the bowel

Iron replacement therapy for the treatment of iron deficiency anemia in adult patients with chronic kidney disease

Human side Effects

Nausea, leg pain, headache, chest pain, hives, vasodilation

Nausea, vomiting, diarrhea, and cramps, iron overload, hiatal hernia

Hypotension, infusion site reactions, gastrointestinal complications, dizziness

Animals toxicology

Despite evidence of long-term toxicity, no iron overload, oxidative stress, pathological brain cell, and myelin changes were detected [298]

There are no carcinogens, genotoxicity, reproductive and developmental toxicity in vivo studies. No neurotoxic side effects have been reported (see Foot note link 14)

Repeat-dose toxicity, reduction in body weight gain and food consumption, enhancement in pigmentation intensity, decrease in fetal weights and external and soft tissue fetal malformations

in vivo studies. No neurotoxic side effects have been reported (see Foot note link 15)