Preventing Accidental Poisoning
by Audrey T. Hingley
FDA's new rules, effective July 15, 1997, require unit-dose packaging for iron-containing products with 30 milligrams or more of iron per dosage unit. Because of the time and effort needed to open unit-dose products, FDA believes unit-dose packaging will discourage a youngster, or at least limit the number of tablets a child would swallow, reducing the potential for serious illness or death. This requirement is in addition to existing U.S. Consumer Product Safety Commission regulations, which require child-resistant packaging for most iron-containing products.
The new rules also now require that labels for all iron-containing products taken in solid oral dosage forms contain the following: "Warning: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately."
Iron is an essential nutrient sometimes lacking in people's diets, which is why iron is often recommended for people with conditions such as iron-deficiency anemia. Taken as indicated, iron is safe. But when tablets are taken beyond the proper dose in a short period, especially by toddlers or infants, serious injury or death may result.
Children poisoned with iron face immediate and long-term problems. Within minutes or hours of swallowing iron tablets, nausea, vomiting, diarrhea, and gastrointestinal bleeding can occur. These problems can progress to shock, coma, seizures, and death. Even if a child appears to have no symptoms after accidentally swallowing iron, or appears to be recovering, medical evaluation should still be sought since successful treatment is difficult once iron is absorbed from the small intestine into the bloodstream. And children who survive iron poisoning can experience other problems, such as gastrointestinal obstruction and liver damage, up to four weeks after the ingested poisoning.
FDA regulates iron-containing products as either drugs or foods, depending on the product formulation and on intended use, as defined by labeling and other information sources.
Some iron-containing products have been regulated as prescription drugs because they included pharmacologic doses of folic acid and usually were prescribed to meet high nutritional requirements during pregnancy.
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