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.

Signs of Poisoning

How can you tell if your child has ingested something poisonous? "Most poisons, with the exception of lead, work fairly quickly. A key is when the child was otherwise well and in a space of hours develops unusual symptoms: They can't follow you with their eyes, they're sleepy before it's their nap time, their eyes go around in circles. Any unusual or new symptoms should make you think of poisoning as a possibility," Rodgers advises. "Poisonings typically affect the stomach and central nervous system. If a child suddenly throws up, that can be more difficult to diagnose."

Other signs of poison ingestion can be burns around the lips or mouth, stains of the substance around the child's mouth, or the smell of a child's breath. Suspect a possible poisoning if you find an opened or spilled bottle of pills.

If you suspect poisoning, remain calm. For medicines, call the nearest poison control center or your physician. For household chemical ingestion, follow first-aid instructions on the label, and then call the poison control center or your doctor. When you call, tell them your child's age, height and weight, existing health conditions, as much as you know about the substance involved, the exposure route (swallowed? inhaled? splashed in the eyes?), and if your child has vomited. If you know what substance the child has ingested, take the remaining solution or bottle with you to the phone when you call. Follow the instructions of the poison control center precisely.

Progress Against Poisonings

The nation's first poison control center opened in Chicago in 1953, after a study of accidental deaths in childhood reported a large number were due to poisoning. Since that time, a combination of public education, the use of child-resistant caps, help through poison control centers, and increased sophistication in medical care have lowered overall death rates.

Often, calling a poison center simply reassures parents that the product ingested is not poisonous. In other cases, following phone instructions prevents an emergency room trip.

Children are not the only victims of accidental poisonings: Older people in particular are at risk because they generally take more medicines, may have problems reading labels correctly, or may take a friend's or spouse's medicine.

In June 1995, the U.S. Consumer Product Safety Commission voted unanimously to require that child-resistant caps be made so adults — especially senior citizens — will have a less frustrating time getting them off. Because many adults who had trouble with child-resistant caps left them off, or transferred their contents to less secure packaging that endangers children, officials say the new caps will be safer for children.

"Childhood poisoning will always be a focus, because children are so vulnerable, especially children under age 5," says Ken Giles, public affairs spokesman for the Consumer Product Safety Commission. "The first two or three years of a child's life are the highest-risk time for all kinds of injuries, so there is a special need to educate new parents. It's essential we keep raising these safety messages that medicines and chemicals can be poisonous."

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Tags: Pediatrics

About the Author

FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.