Preventing Childhood Poisoning (FDA Consumer Reprint)

U.S. Food and Drug Administration
FDA Consumer magazine
March 1996
Table of Contents

This article originally appeared in the March 1996 FDA Consumer, and contains revisions made in June 1997. This article is no longer current.

Preventing Childhood Poisoning

Most people regard their home as a safe haven, a calming oasis in an often stormy world.

But home can be a dangerous place when it comes to accidental poisoning, especially accidental poisoning of children. One tablet of some medicines can wreak havoc in or kill a child.

Childhood poisonings caused by accidental overdoses of iron-containing supplements are the biggest concern of poison control experts, consumer protection groups, and health-care providers. Iron-containing supplements are the leading cause of pediatric poisoning deaths for children under 6 in the United States. According to the American Association of Poison Control Centers, from 1986 to 1994, 38 children between the ages of 9 months and 3 years died from accidentally swallowing iron-containing products. The number of pills consumed by these children varied from as few as five to as many as 98.

In the Jan. 15, 1997, Federal Register, FDA published final regulations that will make it harder for small children to gain access to high-potency iron products (30 milligrams of iron or more per tablet). FDA has also taken steps to ensure that health-care providers and consumers are alerted to the dangers associated with accidental overdoses of iron-containing products, including pediatric multivitamin supplements that contain iron.

Although iron poisoning is the biggest concern when it comes to childhood poisoning, there is also concern about other drugs.

"Over-the-counter diet pills have the potential to be lethal to children, as do OTC stimulants used to keep you awake and decongestant tablets," says George C. Rodgers, M.D., Ph.D., medical director of the Kentucky Regional Poisoning Center. "Tofranil [imipramine], an antidepressant drug also used for childhood bedwetting, and Catapres [clonidine], a high blood pressure medicine, can be very hazardous because it takes very little to produce life-threatening problems in children. One tablet may do it.

"Antidepressant drugs have a high degree of toxicity," he continues. "They are cardiac and central nervous system toxins, and it doesn't take much of them to do harm, particularly in children. They are prescribed fairly ubiquitously. One of the things we look at when we get kids' poisonings is who had the medicine, and why."

Rodgers also urges extra caution when antidepressant drugs are prescribed for teenage patients who may have behavioral or emotional problems.

"Antidepressant drugs are commonly given to adolescents with behavioral problems, and often a month or two-month supply is prescribed. Teens should not be given more than a week's supply to begin with, and parents need to monitor their usage," he says.

"Because they're marketed to look like candy or cartoon characters, it looks like candy and doesn't seem like medicine," he explains.

In addition, children frequently mimic the behavior of their parents. Children who watch their parents take pills may want to do it, too--with potentially fatal results.

Poison-proofing your home is the key to preventing childhood poisonings. In the case of iron-containing pills or any medicine:

The kitchen and bathroom are the most likely unsafe areas. (Medicines should never be stored in the bathroom for another reason: a bathroom's warm, moist environment tends to cause changes or disintegration of the product in these rooms.) Any cabinet containing a potentially poisonous item should be locked.

"Bathrooms with medicines, kitchens with cleaning products, even cigarette butts left out, can be toxic to kids," Rodgers explains. "And remember that child-resistant caps are child-resistant, not childproof. The legal definition is that it takes greater than five minutes for 80 percent of 5-year-olds to get into it: that means 20 percent can get in in less time! Kids are inventive, and can often figure it out. And leftover liquor in glasses on the counter after parties? Don't do it!"

Alcohol can cause drunkenness as well as serious poisoning leading to seizures, coma, and even death in young children. Children are more sensitive to the toxic effects of alcohol than are adults, and it doesn't take much alcohol to produce such effects. Alcohol-laced products, such as some mouthwashes, aftershaves or colognes, can cause the same problems.

Garages and utility rooms should also be checked for potential poison hazards. Antifreeze, windshield washing fluid, and other products should be stored out of children's reach in a locked cabinet. Childproof safety latches can be purchased at your local hardware store.

In the living room or family room, know your plants' names and their poison potential. Although most houseplants are not poisonous, some are. To be on the safe side, keep houseplants out of the reach of young children. Although much has been made of problems with poinsettias (blamed for a death as early as 1919), recent studies indicate it is not as highly toxic as was once believed. Although ingesting it may cause some stomach irritation and burning in the mouth, it's unlikely to be fatal.

"Plants are mostly a problem for children, since it's a natural response for children to taste things. Few adults eat houseplants," Rodgers points out. "Plants have a high capacity for making you sick, but they are usually low-risk for producing life-threatening symptoms." After poison-proofing your home, prepare for emergencies. Post the numbers of your regional poison control center (which can be found on the inside cover of the Yellow Pages or in the white pages of your phone directory) and your doctor by the phone. Keep syrup of ipecac on hand--safely locked away, of course. (See "Antidotes.") Never administer any antidote without first checking with your doctor or poison control center.

Although lead levels in food and drink are the lowest in history, concern remains about lead leaching into food from ceramic ware. Improperly fired or formulated glazes on ceramic ware can allow lead to leach into food or drink.

Long recognized as a toxic substance, adverse health effects can result from exposure to lead over months or years.

After a California family suffered acute lead poisoning in 1969 from drinking orange juice stored in a pitcher bought in Mexico, FDA established "action levels" for lead in ceramic ware used to serve food. Over the years, these original action levels have been revised as research has shown that exposure to even small amounts of lead can be hazardous. The last revision for ceramic foodware was in 1991. On Jan. 12, 1994, FDA published a regulation for decorative ceramic ware not intended for food use, requiring a permanently affixed label on high-lead-leaching products.

"Most lead toxicity comes from multiple exposure and is a slow accumulation over time," says Robert Mueller, a nurse and poison information specialist at the Virginia Poison Center, headquartered at The Medical College of Virginia Hospitals in Richmond. "Refusing to eat, vomiting, convulsions, and malaise can all be symptoms of lead poisoning." Because lead poisoning occurs over time, such symptoms may not show up right away. A blood test is the surest way to determine that your child has not been exposed to significant amounts of lead.

"In general, if a consumer purchases ceramic ware in the U.S. marketplace today, it meets the new action levels," says Julia Hewgley, public affairs specialist with FDA's Center for Food Safety and Applied Nutrition. "But if you travel abroad and buy ceramic ware, be aware that each country has its own safety regulations. Safety can be terribly variable depending on the type of quality control and whether the piece is made by a hobbyist." To guard against poisonings, Hewgley advises that ceramic ware not be used to store foods. Acidic foods--such as orange, tomato and other fruit juices, tomato sauces, vinegar, and wine--stored in improperly glazed containers are potentially the most dangerous. Frequently used products, like cups or pitchers, are also potentially dangerous, especially when used to hold hot, acidic foods.

"Stop using any item if the glaze shows a dusty or chalky gray residue after washing. Limit your use of antique or collectible housewares for food and beverages," she says.

"Buy one of the quick lead tests available at hardware stores and do a screening on inherited pieces."

Iron-containing products remain the biggest problem by far when it comes to childhood poisoning. Between June 1992 and January 1993, five toddlers died after eating iron supplement tablets, according to the national Centers for Disease Control and Prevention's Morbidity and Mortality Weekly Report of Feb. 19, 1993. The incidents occurred in a variety of ways: Children ate tablets from uncapped or loosely capped bottles, swallowed tablets found spilled on the floor, and, in one case, a 2-year-old fed an 11-month-old sibling tablets from a box found on the floor.

Iron is always included in prenatal vitamins prescribed for pregnant women, and is often included in multivitamin formulas and children's supplements. Usually available without prescription, iron supplements can be found in grocery stores, drugstores, and health food stores in a wide variety of potencies, ranging from 18 milligrams (mg) to 150 mg per pill. For a small child, as little as 600 mg of iron can be fatal.

Because iron supplements are typically brightly colored, some people are concerned they may look like candy, and, therefore, are particularly attractive to children. In 1993, the Nonprescription Drug Manufacturers Association (NDMA), which manufactures about 95 percent of nonprescription OTC medicines available to Americans today, adopted formulation provisions for iron products containing 30 mg or more of elemental iron per solid dosage form. These provisions also stipulated that such products would not be made with sweet coatings. That same year, NDMA manufacturers also independently agreed to develop new voluntary warning labels for these products. The voluntary labels read: "Warning: Close tightly and keep out of reach of children. Contains iron, which can be harmful or fatal to children in large doses. In case of accidental overdose, seek professional assistance or contact a poison control center immediately."

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.

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.

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."

Protect Yourself Against Tampering

FDA adopted "tamper-resistant" packaging requirements after seven people in the Chicago area died from taking cyanide-laced Extra-Strength Tylenol capsules in 1982. Although the product met all FDA requirements at the time, it wasn't designed so tampering would leave visible evidence. FDA swiftly enacted new regulations requiring most OTC drug products to be packaged in "tamper-resistant" packaging, defined as "packaging having an indicator or barrier to entry that could reasonably be expected to provide visible evidence that tampering had occurred," and required OTC product labeling to alert consumers to tamper-resistant packaging. In 1989, FDA regulations were amended to require two-piece hard gelatin capsules to be packaged using at least two tamper-resistant features unless sealed with a tamper-resistant technology.

"Consumer vigilance is part of the equation," says Lana Ragazinsky, consumer safety officer with FDA's Center for Drug Evaluation and Research, division of drug quality evaluation, office of compliance. "The consumer is being led into a false sense of security because they see 'tamper-resistant'... 'tamper evident' means you, the consumer, need to look for evidence of tampering."

FDA has proposed changing the term "tamper-resistant" to "tamper-evident" to underscore the fact that no package design is tamperproof. The most important tool to detect tampering is you! Here are a few tips to help protect against tampering:

Antidotes

To induce vomiting in case of accidental poisoning, experts recommend keeping on hand syrup of ipecac--safely stored away from children, of course! Syrup of ipecac induces vomiting, thus ridding the body of the swallowed poison. It usually works within a half-hour of ingestion.

Some medical experts also recommend that parents keep activated charcoal on hand as well: You may have to ask your druggist for it, because it may not be on store shelves. Although some poison control experts recommend having activated charcoal on hand, there is a difference of opinion on its use by consumers. The U.S. Consumer Product Safety Commission, for example, does not recommend that consumers use activated charcoal because it is less palatable to young children.

Activated charcoal (or charcoal treated with substances that increase its absorption abilities) absorbs poison, preventing it from spreading throughout the body. One advantage of activated charcoal is that it can be effective for a considerable time after the poison is swallowed. But activated charcoal should never be used at the same time you administer syrup of ipecac: The charcoal will absorb the ipecac.

For children ages 1 to 12, give one tablespoon of syrup of ipecac followed by one or two glasses of water. Children ages 12 and over should get two tablespoons, followed by one or two glasses of water.

Activated charcoal is usually found in drugstores in liquid form in 30-gram doses. For children under 5, give one gram per every two pounds of body weight. Older children and adults may require much higher doses.

Both antidotes should only be used on conscious poison victims; an unconscious victim should always be treated by professionals.

"Remember to call your local poison control center first before giving your child any at-home antidote," says Robert Mueller, poison information specialist at the Virginia Poison Center in Richmond, Va.