FDA Joins Investigation of Infants’ Deaths Believed to Have Been Caused by Accidental Overdoses of Cold Medicines – Dangerous Nationwide Trend Developing

By Steven DiJoseph

While the Chicago Tribune (2/25/06) is reporting that “accidental overdoses of prescription cold medicines are suspected in the deaths of two Kane County infants in a 24-hour period this winter,” it appears that the problem is anything but isolated.

The coroner for Kane County requested that the federal Food and Drug Administration (FDA) join the investigation because there appears to be a “trend” developing in the form of a dramatic increase in the number of “troubling” deaths in which accidental overdosing may have been involved.

An FDA spokesperson acknowledged that it is aware of the cases and that the agency is actively participating in the investigation.

Although the Illinois deaths are troubling in and of themselves, recent reports from around the U.S. indicate that accidental overdosing of infants is a serious and growing problem. Moreover, the problem is not limited to prescription drugs, as life-threatening overdoses of over-the-counter medications also appear to be on the rise.

As we reported in November 2005, a Montgomery, Ohio Coroner’s investigation discovered a rash of infant deaths linked to improper medicating with cold remedies formulated for older children and that confusion between ‘Pediatric’ and ‘Infant’ dosages is dangerous and likely to be widespread

The Montgomery County Coroner’s Office in Dayton, Ohio, under the direction of Coroner Dr. James M. Davis, operates one of the foremost toxicology laboratories in the country (The Montgomery County Coroner’s Office Toxicology Laboratory). It was therefore not surprising that its highly trained staff of toxicologists decided to investigate an unusually large number of infant deaths that were not readily connected to any specific cause.

As reported in the Hamilton, Ohio, Journal News (11/14/05):

“At a routine morning meeting about a year ago, the coroner’s office staff decided to delve deeper into the deaths of infants who died for no immediately obvious reason, deaths that fell within the range of those that could be attributed to Sudden Infant Death Syndrome.

The office had acquired new, highly sophisticated equipment able to test for a variety of drugs commonly found in over-the-counter cold medications.

During the next eight months, the office encountered 10 deaths of infants — children 12 months and younger — in whose systems were found such common cold-fighting components as pseudoephedrine, dextromethorphan and acetaminophen.”

Accidental OTC Drug Overdosing is neither New nor Unusual


The correct and safe dosages for prescription and over-the-counter (OTC) drugs are almost always dictated to a large extent by the weight and age of the patient.

Infants, children, adolescents, adults, and the elderly are differentiated between when it comes to how much of a drug can be tolerated at any given time as well as if taking a particular drug is even proper in the first place.

Dosage variations or restrictions based on age and/or weight differentials are commonly included in “dosing charts” on a drug’s package or information label. Pharmacists also provide computer printouts of this data when necessary.

While healthcare professionals always have access to this information and are expected to adhere to it when prescribing a medication or suggesting an OTC remedy, the same cannot be said of consumers, however.

All to often, patients “share” prescription medication with friends or relatives believing that it is safe as long as the other person has (what appears to be) the same medical problem. Thus, it is not uncommon for some very powerful (and dangerous) prescription medication to find its way to people who should not be taking it at all or who need a completely different dosage because of their age or weight.

The problem with OTC medications is even more serious since there is usually no medical professional involved in the decision as to which product is taken and how much of it is used. Dosing charts are often ignored, thrown away, or misunderstood. There may even be problems with the clarity of the instructions or the accuracy of measuring devices included with the product.

At the beginning of August 2005, for example, the FDA announced that Perrigo Co. was voluntarily recalling all lots of four types of its concentrated infants’ liquid pain, cough, and cold drops that come packaged with syringes that could cause the youngest infants to receive overdoses of the various active ingredients including acetaminophen.

The oral syringes which Perrigo distributed with these over-the-counter liquid medications were not marked to measure doses of less than 1.6 milliliter which may be prescribed for children younger than 2 and less than 24 pounds. Ingesting too much acetaminophen, a pain-relieving ingredient, may cause liver damage. Previously, the medications had been distributed with droppers that had different markings. The new markings “caused some confusion among consumers and health-care professionals and may lead to improper dosing,” the FDA said.

The Chicago Tribune article noted a similar situation in at least one of the deaths in Kane County where “the prescribed dosage of medicine was 0.2 milligrams, he said, but the dropper that was used, which measures 1 milligram when full, could lead a confused caregiver to deliver 2 droppers-full of medicine instead of just two-tenths of one dropper.”

Even the maker of the OTC painkiller, Tylenol, states in a TV ad that it would rather you not take the product at all if you are not going to follow the recommended dosage.

Clearly, OTC drugs are serious medications and must be treated as such. The fact that a prescription is not required does not make an OTC drug safer or allow consumers to make dosing decisions that should be left to a physician.

Taking a few extra OTC painkillers to get relief, multiplying or dividing recommended dosages depending on a child’s weight, or ignoring warnings concerning dangerous interactions is like playing Russian roulette.

Each year, OTC drug overdoses and interactions send thousands of people to hospital emergency rooms and kill scores of others. When a parent or caregiver decides, without any medical advice, that half a dropper of a children’s cold remedy is perfectly fine for a 18-pound, 10-month-old infant simply because the recommended dose for a much heavier 2-year-old child is one full dropper, the stage is set for a potentially deadly overdose.

An infant’s developing bodily systems are often far too immature (or even undeveloped) to expose to toxic medications without specific medical advice and supervision.

The Coroner’s Toxicological Investigation Produces Startling Results

The eight-month investigation, headed by Laureen Marinetti, Chief Toxicologist, that found such common cold-fighting components as pseudoephedrine, dextromethorphan and acetaminophen in the remains of 10 infants under the age of 12 months, disclosed levels of these drugs and others that were “astronomical” in many of the cases according to Dr. Davis.

Davis believes the children died because parents and caregivers simply weren’t paying enough attention to the age ranges for which the medications were intended.

“There’s a huge difference in pediatric dosing and infant dosing,” Davis said. “What’s happening is people are not reading the labels. They’re picking up over-the-counter medicine for a 2 year old and giving it to an infant.

“It’s not all their fault,” he said. “One of the problems is when you go to a pharmacy, all the cold preparations are mixed together, both the infant preparations and pediatric children’s. You have to be careful what you’re buying.”

According to Ernest Boyd, executive director of the Ohio Pharmacists Association: “Whenever someone buys medication for an infant, they need to talk to a pharmacist right then and there. They need to be sure they’re getting the right thing — even how to use the dosage spoons.

“Any of these over-the-counter medications, if not given in the proper doses, can be dangerous. People need to be doubly — triply — sure before they medicate an infant at all. They need to be fantastically careful when dosing a baby.”

Davis believes the coroner’s study, published in the October issue of the Journal of Analytical Toxicology, is one of the first of its kind to tie incorrect dosage of over-the-counter medications to infant deaths.

“This is big,” Davis said. “This is an issue that hasn’t been recognized, and we’re trying to get word out.”

The study is published under the title “CASE REPORT: Over-the-Counter Cold Medications— Postmortem Findings in Infants and the Relationship to Cause of Death (Authored by Laureen Marinetti, Lee Lehman, Brian Casto, Kent Harshbarger, Piotr Kubiczek, and James Davis – Montgomery County Coroner’s Office, 361 West Third Street, Dayton, Ohio 45402).

The essence of the report is that the Coroner’s Office encountered 10 deaths over an 8-month period in infants less than 12 months old with toxicology findings that include a variety of drugs commonly found in OTC cold medications.

The drugs detected were ephedrine, pseudoephedrine, dextromethorphan, diphenhydramine, chlorpheniramine, brompheniramine, ethanol, carbinoxamine, levorphanol, acetaminophen, and the anti-emetic metoclopramide.

Toxicology findings were confirmed in 2 different matrices in 9 of the 10 cases and by 2 different analytical methods. The majority of these deaths were either toxicity from the OTC cold medications directly or as a contributory factor in the cause of death. Two of the cases were the result of possible child abuse.

The report authors believe that parents and other caregivers may be under the mistaken belief that OTC cold medications formulated for “children” are also safe for use in “infants.”

The toxicologists involved in the investigation said that these specific cases demonstrate the administration of some OTC cold medications is not safe and can result in fatal levels of toxicity in infants who have been exposed to contraindicated doses of such drugs or their active ingredients.

Clearly, then, there is nothing new about the problem encountered in Illinois over the past winter. The evidence shows that many infants are dying from accidental overdoses of prescription and OTC cold medications because of human error, confusing marking on measuring devices, and other preventable mistakes.

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