Table 1. Iron-containing nonbiological complex drugs and their current status.
Formulations of iron-containing complex drugs are summarized along with the information regarding their composition, indication, FDA approval status, manufacturer, and (when applicable) reason(s) for withdrawal from market. N.A. – not applicable; Inj. – injection; IONP – iron oxide nanoparticles
| Formulation Name | Description of formulation |
Coating Material | Clinical Application | FDA status | Reason for Withdrawal |
Manufacturer | Brand/ Generic |
References |
|---|---|---|---|---|---|---|---|---|
| Feridex I.V/Ferumoxide/Endorem | IONP | Dextran | Liver imaging | Withdrawn (2008) | Hypotension, lumbar pain/leg pain, local pain, and hypersensitivity | Bayer HealthCare | Brand | [21, 50] |
| Resovist/Cliavist | IONP | Carboxydextran | Liver imaging | Withdrawn (2009) | Vasodilatation and paraesthesia | Bayer HealthCare | Brand | [29, 50] |
| Combidex/Ferumoxtran-10/Sinerem | IONP | Dextran | Prostate cancer lymph node metastases MRI | Withdrawn (2007) | Anaphylactic shock (1) and lack of improved efficacy | Advanced Magnetics, Inc./AMAG Pharma | Brand | [21, 22] |
| Feraheme/Ferumoxytol | IONP | Polyglucose sorbitol carboxymethyl ether | Iron deficiency in adult chronic kidney disease patients | Approved (2009) | N.A. | AMAG Pharma | Brand | [54, 55] |
| Lumirem/Gastromark | IONP | Silica | MRI of gastrointestinal lumen | Approved (1996) | N.A. | Guerbet | Brand | |
| Clariscan/Feruglose | Iron Dextran Inj. | Carbohydrate polyethylene glycol | MR angiography, tumor microvasculature MRI | Development discontinued | . | GE Healthcare | N.A. | [50, 51] |
| Ferrisat | . | Dextran | Iron-deficient anemia | Approved (1992) | N.A. | In France/Generic by Bayer in the US | Brand/Generic | |
| Venofer | Iron Sucrose Inj. | Sucrose complex | Iron-deficient anemia following autologous stem cell transplantation | Approved (2000) | N.A. | American Regent, Inc. | Brand | |
| DexFerrum/DexIron/Infed | Iron Dextran | Dextran | Iron-deficient anemia | Approved (1996) | N.A. | American Reagent, Inc./Allergan | Generic/Brand | |
| Ferrlecit | Sodium ferric gluconate | Sodium gluconate complex | Iron-deficient anemia | Approved (1999) | N.A. | Sanofi, Inc. | Generic/Brand | |
| Injectafter/Ferinject | Ferric carboxymaltose | Carboxymaltose | Iron-deficient anemia | Approved (2013) | N.A. | Vifor Pharma/American Regent, Inc.(Luitpold) | Generic/Brand | |
| Nanotherm | IONP | Aminosilane | Magnetic thermal ablation | Approval awaited | N.A. | MagForce AG | Brand |