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New Study Suggests Excipient Levels in Medications Could Pose Toxic Danger to Infants

Mar 1, 2009

As is often the case in the world of pharmaceuticals, however, even "harmless" substances can wind up causing serious problems in certain situations. Certain prescription drugs may have dangerous interactions with such things as sunlight, grapefruit juice, and Over-the-Counter (OTC) remedies. Now, researchers at Leicester Royal Infirmary (LRI) in the UK, led by Dr Hitesh Pandya., have found that premature infants are routinely exposed to pharmaceutical excipients at levels which could potentially be toxic. The results of their analysis can be found in the Fetal & Neonatal edition of Archives of Disease in Childhood for January 20, 2009.

An "excipient" is defined as "a usually inert substance (such as gum arabic, syrup, lanolin, or starch) that forms a vehicle (as for a drug or antigen); especially: one that in the presence of sufficient liquid gives a medicated mixture the adhesive quality needed for the preparation of pills or tablets.

In their study, the researchers documented exposure to excipients in medications given to 38 premature babies, who were cared for in the neonatal unit at LRI over the course of a year. The team concluded at least some of the infants were being exposed to excipient concentrations even in excess of the maximum exposure limits for adults.

The excipients in question are added to liquid medications for oral ingestion. This is a common practice in the administration of drugs to premature infants designed to improve their taste and absorption, and to extend shelf-life.

Although the purpose of the study was not to explore potential links between excipients and their possible side effects in infants, the researchers believe the level of exposure they identified "will understandably generate concern among parents, nurses, pharmacists and paediatricians." They suggest medications with lower levels of expedients should be developed specifically for premature infants on a priority basis. At the moment oral liquid medications tend to be developed based on adult human and animal studies which may not be relevant to premature infants.  

Seven of the 38 infants in the study suffered from chronic lung disease (CLD), a common complication often seen in premature infants. The infants' records showed they were had been given eight oral liquid drugs containing 20 excipients. The seven infants with CLD had been exposed to higher levels of excipients.

The excipients the researchers found included such chemicals as propylene glycol and ethanol, which have already been identified as a neurotoxin. Also found were high levels of sorbitol. Significantly, the team also discovered the presence of Ponceau 4R (a coloring agent) in an iron supplement formulation. The UK Food Standards Agency has already recommended this excipient be removed due to concerns that it may be potentially harmful to a child's neurological development and behavior.

In their report, the researchers stated: "We feel it is important that the European Medicines Agency/Medicines and Healthcare Products Regulatory Agency ... only ensures that all manufacturers provide detailed labelling of the excipient content of their products." Dr. Pandya further stated: "We are planning further studies on the chemicals to understand exactly what these effects might be."

The team is hopeful that the appropriate regulatory bodies will take action "to determine whether existing practice constitutes a risk and, if so, how this might be dealt with."

Overdosing of infants has consistently been a problem with respect to pharmaceutical products. Thus, it is easy to understand why the same apparently holds true for excipients that are contained in medications.

To understand why small infants are at risk when exposed to dosages of any medication designed for older children or adults, one need only consider the ever-increasing awareness of the potentially fatal effect over-the-counter (OTC) cold remedies designed for "children" have when given to infants.

In November 2005, findings were released by the Montgomery, Ohio, Coroner's Office that linked a number of infant deaths 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. 

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.

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.

Since 2005, there have been 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.  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.

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."

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.

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.

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.


In October 2007, some over-the-counter infant cough and cold medicines were recalled by their manufacturers because of the concerns about the safety and effectiveness of such drugs. Studies by the Centers for Disease Control (CDC) and the Food and Drug Administration (FDA) increased calls for such medications to be banned.

Up until that time, the FDA had concluded that if OTC cold preparations were safe and effective for adults, then smaller doses would be safe and effective for infants. The studies proved that assumption wrong. The CDC found that between 2004 and 2005, 1,500 children under the age of 2 had been injured by common over-the-counter decongestants and antihistamines, while the FDA found that from 1969 to 2006, at least 54 children died after taking over the counter decongestants, and 69 died after taking over-the-counter antihistamines. The FDA safety reviewers actually recommended a ban on all over-the-counter infant cold medications.

On October 19, 2007, an FDA advisory panel recommended a ban on over-the-counter cough and cold medicines for children younger than 6 and on January 17, 2008 the agency issued a Public Health Advisory for parents and caregivers recommending they do not give OTC cough and cold medicines to infants younger than 2 because they can lead to serious and fatal side effects.

Clearly, the message to be taken away from all of this is that premature babies and infants cannot and must not be lumped in with toddlers, older children, or adults when it comes to potential side effects from medications or even their so-called harmless excipients.

As always, if you believe that you or a loved one has suffered an injury as a result of taking a prescription drug or OTC medication, do not hesitate to contact Parker Waichman LLP at for a free consultation with one of our experienced attorneys.  


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