Children’s Iron Poisoning Curbs Planned : Health: FDA proposes safer packaging and stronger warnings. Since 1986, accidental ingestion of the product has resulted in at least 33 deaths.

The Food and Drug Administration Wednesday proposed stronger warnings, safer packaging and other measures to prevent accidental iron poisoning in children, the leading cause of poisoning deaths in children under the age of 6.

Despite child-resistant caps, more than 110,000 cases of accidental ingestion of iron occurred between 1986 and 1992, leading to at least 33 deaths and numerous hospitalizations, the FDA said.

The average age of the children who died was 16 months. Some had consumed as many as 90 tablets, agency officials said.

“These proposals have the potential to eliminate deaths and injuries from iron poisonings,” FDA Commissioner David A. Kessler said. “Everyone who takes care of small children needs to understand that iron can be toxic and even fatal.”

Part of the problem has been caused by prenatal iron products taken by pregnant women, which typically contain 30 milligrams or more of iron and can often be found in households with young children, the FDA said.

Also, children’s vitamins are sweetened or flavored to make them more palatable and children often regard them as candy, Mary Pendergast, FDA deputy commissioner and a senior adviser to Kessler, said.

Although iron poisoning was a more significant problem before the introduction of child-resistant caps in 1978, more than half of the accidents reported in recent years involved products that had the safer packaging, the agency said. The caps are required on bottles of vitamins and other medicines containing 250 milligrams or more of iron.

“Children can get it (a child-resistant cap) open if they work at it,” Pendergast said. “Also, many parents often just open a bottle, leave it on the table, and say: ‘Everybody take one.’ The 12-year-old takes one. The 10-year-old takes one. And then the toddler eats the rest of the bottle.”

The new regulations would require any product with 30 milligrams or more of iron per pill or capsule to be sold in individual dose packaging, such as blister packs, to make it more difficult for small children to open.

The FDA also proposed that labels feature a conspicuous warning urging parents to secure child-resistant closures properly, to keep them out of reach of children and to seek immediate medical attention if a child accidentally swallows the product--even if the child does not show symptoms of poisoning.

The proposals are subject to a 75-day public comment period and final regulations are expected until early next year. Once the regulations are final, the new packages would be required to appear in the marketplace within six months, the agency said.

Industry is expected generally to support the proposals.

“Consumers need to recognize that iron supplements are safe and beneficial when used appropriately, for children as well as adults. But accidental ingestion of large doses by young children must be prevented,” said Annette Dickinson, director of scientific and regulatory affairs for the Council for Responsible Nutrition, which represents the nutritional supplement manufacturers.

Iron toxicity in young children depends on the dose and the weight of the child. Generally, 250 milligrams would make a toddler sick, and at least 650 milligrams would be lethal, Pendergast said.

A 22-pound child, for example, would become ill after taking about 15 children’s vitamins, or as few as three adult high potency vitamins, Pendergast said.

Iron poisoning can cause both immediate and long-term medical problems.

Within minutes of swallowing iron tablets, children can experience nausea, vomiting, diarrhea, and gastrointestinal hemorrhage, which can progress to shock, coma and death, the FDA said.

Even if a child appears to recover initially, severe gastrointestinal hemorrhage, lethargy, liver damage, heart failure, and coma can occur 12 hours to two days later. If a child survives, additional problems such as gastrointestinal obstruction and more extensive liver damage may also appear as long as six weeks after the poisoning, the agency said.

There is no record of children poisoned by consuming liquid or powders containing iron, although these products could also be toxic in large amounts, the FDA said. Therefore, the agency is seeking public comment on whether these products should also be covered by the new requirements.

The agency is also exploring whether iron-containing products should be reformulated or require different coatings to avoid their resemblance to candy.