U. S. Food and Drug Administration
FDA Consumer Update
December 1994
Preventive Measures Proposed for Childhood Iron Poisoning
To prevent accidental, potentially fatal childhood poisonings, FDA is proposing that packages of capsules and tablets containing iron be labeled with warnings.
The proposal, published in the Oct. 6, 1994, Federal Register, applies to prescription and nonprescription products. It would require manufacturers to enclose any product with 30 milligrams or more of iron per pill or capsule in single-dose packaging, such as blister packs. Most prenatal iron products contain 30 mg or more of iron and are likely to be in homes with young children.
Accidental ingestion of iron is the leading cause of poisoning deaths in children under 6, despite child-resistant packaging. Since 1986, over 110,000 such incidents have been reported, leading to 33 deaths.
The proposed warning would appear in a conspicuous area on all solid oral-dosage products containing elemental iron or iron salts. It would state that an iron overdose could harm or kill a child and would caution adults to:
- Make sure the packages are not left open or within reach of children.
- Secure child-resistant closures properly.
- Keep unit-dose packaged products in original containers.
- Store products out of children's reach.
- Seek immediate medical attention if a child accidentally swallows the product.
The agency seeks public comment on other issues, such as whether the proposal should cover liquid or powdered iron products (which have no record of accidental poisonings), whether iron-containing products should be reformulated, and whether different coatings should be used to avoid making products look like candy.
This is a mirror of the page at
http://www.fda.gov/fdac/departs/upd_iron.html
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