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Mar 1, 2007 Other common drug-related errors also expose infants to potentially deadly results

For the past two years, there has been an ever-increasing awareness of the potentially fatal effect over-the-counter (OTC) cold remedies designed for “children” have when given to infants.

Initially, in November 2005, findings were released by the Montgomery, Ohio, Coroner’s Office after an investigation unearthed a rash of infant deaths linked to improper medicating with cold remedies that were intended for older children.  This prompted health officials in other states as well as at the Centers for Disease Control (CDC) and the Food and Drug Administration (FDA) to start their own inquiries into the apparent harmful and often deadly confusion between “pediatric” and “infant” dosages for OTC cold medications.  

Since 2005, there have been two other major occurrences of infant deaths linked to improper dosages of over-the-counter medications, causing physicians and medical professionals to advise patients to seek medical advice from a professional even in regards to OTC medications when it comes to infants and children.  When mistakes can be fatal, parents and caregivers can never be too cautious and sometimes interpreting labels can be more difficult than it seems.

The Ohio Case

The Montgomery County Coroner’s Office in Dayton, Ohio, under the direction of Coroner Dr. James M. Davis, 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:
“At a routine morning meeting [in 2004], 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.”

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 believed 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,” said Boyd, who had not yet seen the study. “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 believed the coroner’s study, published in the October 2005 issue of the Journal of Analytical Toxicology, was 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 was 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).

At the time, the Coroner’s Office said that they encountered 10 deaths over an 8-month period in infants less than 12 months old with toxicology findings that included 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 believed 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 demonstrated that 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.

The Chicago Case

On February 26, 2006 the Chicago Tribune ran a story regarding the deaths of two Kane County infants within a 24-hour period and attributed these deaths to accidental overdoses of prescription cold medicines.

The coroner for Kane County requested that the 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 was aware of the cases and that the agency was 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 OTC medications also appear to be on the rise.
The Chicago Tribune article noted a similar situation to the Ohio deaths 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.”

The Atlanta Case

Researchers in Atlanta found that prescription and over-the-counter cough and cold remedies were responsible for the deaths of three infants.
The autopsies of two boys and one girl, between the ages of one to six months, revealed that all three children had high levels of the nasal decongestant pseudoephedrine in their blood.  

According to the investigators, the cough suppressant dextromethorphan and Tylenol (acetaminophen), were noticeably present in the blood of two of the infants. In addition, the blood levels of pseudoephedrine found in the children were nine to 14 times higher than the recommended doses of the decongestant for children who are ages two to 12 years.

"Because of the risks for toxicity, absence of dosing recommendations, and limited published evidence of effectiveness of these medications in children ages younger than 2 years, parents and other caregivers should not administer cough and cold medications to children in this age group without first consulting a health-care provider and should follow the provider's instructions precisely," the investigators wrote.

They went on to say that clinicians should also be careful when administering or prescribing cough and cold medications and fever reducers to children under the age of 2.  Most children’s medications are not intended for children under the age of 2 and even giving small dosages can cause harmful effects.  

Clinicians should also always ask caregivers if they are using or plan to use OTC medications before prescribing any other drugs to treat infant illnesses to make sure that there are no fatal combinations or possibilities for overdose.  

Sadly, all three infants had ingested cough-and-cold remedies containing pseudoephedrine, and one had even been given both a prescription preparation and OTC medication containing the vasoconstricting decongestant.

Two of the children had also been given prescriptions containing the antihistamine carbinoxamine. Carbinoxamine was banned by the FDA following the reports of these infant deaths, citing that it contained medications that they had never approved.  Since those deaths occurred, the FDA banned the manufacture of carbinoxamine-containing medications that the agency had not specifically approved.

Although the occurrence of adverse events associated with the use of cough and cold remedies in children is low, the fact that these reports continue to surface serves to remind us that these drugs are not now, nor have they ever been, completely safe for use in infants.  

The fact is that health professionals remain uncertain as to what constitutes a “safe” dose of cough and cold medications for infants and toddlers under two years old; and there are no FDA recommendations for clinicians who prescribe for young children.

Interestingly enough, a comprehensive review of controlled clinical trials published in 2004 by the Cochrane Collaboration, revealed that over-the-counter cough and cold products were no more effective than placebo in reducing acute cough in children under age two. Thus, it would certainly appear that, in the case of infants under the age of two, extreme caution should be taken to limit medications to only those that are absolutely necessary and then only under strict medical supervision with special attention being given to any measuring device or dosage chart to be certain that the amounts being given are strictly those for infants and not toddlers or children. When OTC medications are involved, if there is any doubt at all, it is clear that parents and caregivers would be better off not administering any such remedy to an infant under the age of two.  

The Center for Disease Control, working with the National Association of Medical Examiners, gathered records of cases of infant deaths linked to OTC medications occurring in 2004 and 2005 in the United States and Canada.
Researchers found that the deaths of three children from two states were 100% attributable to cough and cold medication overdose.  One child was determined to have died from pseudoephedrine intoxication, one from combined pseudoephedrine and dextromethorphan intoxication, and one from unspecified drug poisoning.

"Few data exist regarding the therapeutic or toxic levels of cough and cold medications in children younger than two years," the Morbidity and Mortality Weekly Report editors wrote. "Blood levels of cough and cold medications revealed in postmortem studies might not reflect levels in the bloodstream at the time of administration. However, in this report, the blood levels of pseudoephedrine found in the three patients ages one to six months were approximately nine to 14 times the levels resulting from administration of recommended doses to children ages two to 12 years."

The editors recommended that instead of giving infants decongestants, saline nose drops or a cool-mist humidifier can be a safer alternative to try and alleviate cold and cough symptoms.  

Consumers Should Use Common Sense and Caution at All Times

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 (or drug) 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. This problem is only getting worse as more and more prescription drugs are being approved in OTC varieties or dosages.

In August of 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.

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.

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 can, it seems, be deadly.

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.

As always, the attorneys at Parker Waichman LLP are dedicated to bringing the public the most up-to-date information regarding pharmaceutical products, medical devices, toxic substances, and other consumer products with the potential to inflict serious injuries or death. If you or a loved one has suffered an injury (or death) that may be attributable to any product, do not hesitate to contact us at for a free and thorough case evaluation.
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