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Toxicity of Over-the-Counter Cough and Cold Medications PDF Print E-mail
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Saturday, 01 September 2001 00:00
“Over-the-counter (OTC) cough and cold medications are marketed widely for relief of common cold symptoms, and yet studies have failed to demonstrate a benefit of these medications for young children. In addition, OTC medications can be associated with significant morbidity and even mortality in both acute overdoses and when administered in correct doses for chronic periods of time. Physicians often do not inquire about OTC medication use, and parents (or other caregivers) often do not perceive OTCs as medications. We present 3 cases of adverse outcomes over a 13-month period including 1 death as a result of OTC cough and cold medication use. We explore the toxicities of OTC cough and cold medications, discuss mechanisms of dosing errors, and suggest why physicians should be more vigilant in specifically inquiring about OTCs when evaluating an ill child.”

“Colds, coughs, and upper respiratory infections are common childhood illnesses. The average child suffers from 6 to 10 colds per year, and each cold can last from 10 to 14 days, providing several days and nights of discomfort for the child as well as for his/her caregiver. Many times parents will turn to one of many hundreds of cough and cold preparations for relief. However, over-the-counter (OTC) cough and cold preparations although generally safe have no demonstrated benefit. No studies have proven the efficacy of cough and cold preparations in facilitating recovery from these illnesses, and most children will eventually improve on their own. However, a small number of children may suffer significant adverse effects from the administration of the very cough and cold formulations they were given in an attempt to relieve their symptoms. For example, the Food and Drug Administration recently issued an advisory to remove phenylpropanolamine (PPA) a common constituent of OTC decongestants from those products because of concern for increased risk of hemorrhagic stroke.”

“OTC cough and cold preparations are nearly ubiquitous, and are marketed for the relief of those most irritating symptoms of the common cold: rhinorrhea and cough. Although they may alleviate some symptoms in adolescents and adults, many studies have demonstrated that OTC cough and cold preparations do not achieve such claims in the younger pediatric population. In fact, studies in children of the immediate, short-term (within 48 hours), and long-term (after 72 hours) effects of cough and cold preparations showed no significant difference between OTC medications and placebo in the reduction of cough. In addition, OTC cough and cold medications are associated with potentially serious side effects.”

“In 1997, the American Academy of Pediatrics (AAP) issued a statement on the use of codeine- and dextromethorphan-containing cough remedies in children, concluding that physicians should clearly educate parents about the known risks and lack of benefits of these medications. We chose to report these cases because they represent the range of severity of adverse outcomes that can be seen with OTC cough and cold preparations. In addition, a review of the recent literature does not reveal reports of heart failure or death attributable to such medications. Finally, our case reports from a single institution reflect 3 episodes in just over 1 year that required admission, and most likely only represent the "tip of the iceberg" of adverse outcomes attributable to OTC cough and cold preparations.”

“The potential toxicities of cough and cold medicines vary with their composition. Many products contain multiple substances including a decongestant, cough suppressant, antihistamine, and/or antipyretic/analgesic. Pseudoephedrine and PPA are sympathomimetics that reduce nasal congestion by stimulating the -andrenergic receptors on vascular smooth muscles. Clinical toxicity presents with central nervous system (CNS) stimulation, hypertension, and tachycardia with ephedrine or pseudoephedrine ingestion, and bradycardia with PPA ingestion. CNS stimulation can manifest as extreme agitation, restlessness, insomnia, psychosis, and seizures. Serious complications after decongestant ingestions and/or overdoses include hypertension, tachycardia, bradycardia, seizures, stroke, and cerebral hemorrhage. Dysrhythmias, myocardial infarction, and ischemic bowel infarction have also been reported.”

“Many reports of severe hypertension after therapeutic and toxic doses of PPA have been published, some of which resulted in intracranial hemorrhage and death.”

“Many cough and cold preparations even include antihistamines such as chlorpheniramine and brompheniramine although histamine has not been shown to contribute to the symptoms seen in the common cold. Adverse effects and clinical toxicity of antihistamines are characterized by a spectrum of anticholinergic symptoms and CNS depression. Tachycardia, blurred vision, agitation, hyperactivity, toxic psychoses, and seizures may be evident. Cardiac dysrhythmias including torsades de pointes have also been reported. Dextromethorphan, an antitussive, has also been associated with toxic side effects such as lethargy, stupor, hyperexcitability, ataxia, abnormal limb movements, and coma.”

“Cough and cold medicines, therefore, are not administered without risk. In 1 analysis of poison control reports of 249,038 exposures to cough and cold preparations in children <6 years old, there were 72 "major events" and 4 deaths. These numbers are probably falsely low resulting from reliance of this data on voluntary reporting. Other children may have adverse outcomes from cough and cold preparation use, but may not be reported to the poison control centers due to self-limited reactions, failure to recognize the reaction (eg, the child slept through the sedation), lack of reporting by the medical facility, or a lack of acknowledgment that OTC medications had been administered.”

“In addition to side effects of the various ingredients, OTC cough and cold preparations also present potential hazards due to dosing errors. The first and third case reports demonstrate negative outcomes attributable to acute and chronic dosing errors. Little published data exists on levels of OTC cough and cold preparations in infants and children; thus, dosing guidelines historically have been extrapolated from adult data, making them imprecise for children. In 2 studies, caregivers reported that they primarily followed dosing guidelines on the medication package; however, this too allows for many potential errors. They can misunderstand the recommended dose, frequency or length of therapy, use an incorrect measuring device, or even give the wrong preparation. In our second case report, well-intentioned parents were giving their child what they perceived to be only an antipyretic; however, because of package labeling the Cold portion of the name Children's Tylenol Cold was in much smaller print they did not realize that what they had actually been giving was a cough and cold preparation.”

“Some parents may intentionally give children supratherapeutic doses of cough and cold preparations, exceeding either the recommended dose amount or length of therapy. When appropriate doses of pediatric formulations don't achieve the desired outcome, parents may increase the dose, or give adult preparations that may be perceived as stronger. Kapasi et al noted in a study of acetaminophen use, that a significant percentage of poisonings from acetaminophen were secondary to excessive dosing, rather than unintentional ingestion. In the third case report, the child tragically died from an overdose of cough and cold medications that likely had been persistently administered because of continued symptoms in the child.”

“Other parents, while recognizing that OTC cough and cold medications do not relieve the cold symptoms, may continue to use these medications for 1 of the side effects sedation. Additionally, many parents may simply be unaware of the potentially serious side effects of OTC cough and cold medications.”

“Despite the risks of OTC cough and cold medicines, many parents believe they should treat their children's cold symptoms with medication. Cold remedies are a formidable industry; in 1990 alone, nearly $2 billion was spent on OTC cough and cold preparations nationwide. In 1991, Hutton et al conducted a randomized, controlled trial evaluating the efficacy of an antihistamine-decongestant preparation versus placebo, and noted that parents reported greater symptom improvement in children who received medicine even if it was a placebo. This parental observational bias suggests that parents in this study felt the need to treat their children's cold symptoms, and perceived more improvement when they received therapy.”

“Many providers fail to give specific instructions on OTC cough and cold medication use even when they are aware that the patient is using them. In addition, some providers have a lack of knowledge regarding the various ingredients in cough and cold preparations. Finally, not only are many physicians unsuccessful in educating parents about the risks of OTC cough and cold preparations, some physicians continue to prescribe them for their patients despite their lack of demonstrated efficacy. Gadomski and Horton described 2 such cases where a physician-prescribed cough and cold preparation produced an adverse outcome in the patient because of inappropriate dosing by the parents. Although the AAP guidelines do not state that physicians should not prescribe OTC cough and cold preparations, they do clearly state that physicians have a responsibility to educate parents about the lack of benefit and known risks of OTC cough and cold preparations. It is our belief that for those families who insist on using OTC cough and cold preparations, physicians should negotiate to discontinue use in 2 days if there is no appreciated benefit.”

“Three cases of children experiencing significant adverse effects and toxicity from OTC cough and cold preparations are presented. Health care providers have the opportunity to intervene by inquiring specifically about OTC cough and cold medication use, and by educating parents on the lack of demonstrated benefit and known risks in the pediatric population as recommended by the AAP.”


Veronica L. Gunn, MD, Samina H. Taha, MD, Erica L. Liebelt, MD, and Janet R. Serwint, MD, "Toxicity of Over-the-Counter Cough and Cold Medications", Pediatrics, September 1, 2001, Vol. 108, Num. 0, pp. e52

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