Easy on the Stomach
Who wants a therapy that brings on a lot of uncomfortable side effects? Ferralet® 90 contains carbonyl iron. Carbonyl iron has been proven to be safe.1 In fact, in one study, carbonyl iron was given at 10 times the dose of ferrous sulfate. The two therapies were compared, and even at the greatly increased dose, the carbonyl iron showed no significant difference in GI side effects.1
Results like these are impressive. So much so, in fact, that a well-known medical textbook called Conn's Current Therapy 2008 asserts that carbonyl iron is recommended for most people.2
Accidental Poisoning in Children
Let's face it, as vigilant as we try to be, children sometimes get into places they shouldn't. Accidental iron overdose can be very dangerous, even fatal, to small children. Carbonyl iron is widely recognized as a safer choice, and in one study was shown to be 250 to 300 times as safe as traditional irons.3 This is one reason why, when the Food and Drug Administration required iron products to be packaged in single-dose containers, carbonyl iron was singled out as the only iron that was given an exception to the requirement.4
Important Safety Information
WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.
Warning
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.
Precautions
Administration of Drug- General: Take 2 hours after meals. Do not exceed recommended dose. Discontinue use if symptoms of intolerance appear. The type of anemia and underlying cause or causes should be determined before starting therapy with Ferralet® 90 tablets. Ensure Hgb, Hct, reticulocyte count are determined before starting therapy and periodically thereafter during prolonged treatment. Periodically review therapy to determine if it needs to be continued without change or if a dose change is indicated. This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.
- Folic Acid: Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. Pernicious anemia should be excluded before using these products since folic acid may mask the symptoms of pernicious anemia.
- Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
- Geriatric Use: Dosing for elderly patients should be cautious. Due to the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy, dosing should start at the lower end of the dosing range.
This material is intended to provide basic information. Patients should discuss all medical advice, diagnosis, and treatment with their healthcare provider.
Please see full Prescribing Information
- Gordeuk VR, Brittenham GM, Hughes M, Keating LJ, Opplt JJ. High-dose carbonyl iron for iron deficiency anemia: a randomized double-blind trial. Am J Clin Nutr. 1987 Dec;46(6):1029-34.
- Barton JC. Iron deficiency. In Rakel RE, Bope ET. Conn's Current Therapy, 2008. Amsterdam, The Netherlands: Saunders/Elsevier, 385-389.
- Brittenham GM, Klein HG, Kushner JP, Ajioka RS. Preserving the national blood supply. Hematology Am Soc Hematol Educ Program. 2001;:422-32.
- Rules and Regulations. Fed Regist. 1997;62(10):2239.
