Toxicity of Over-the-Counter Cough and Cold Medications

Abstract

ABSTRACT. 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. Pediatrics 2001;108(3). URL: http://www.pediatrics.org/cgi/content/full/108/3/e52; over-the-counter medications, cough and cold preparations, morbidity, mortality, phenylpropanolamine.ABBREVIATIONS. OTC, over-the-counter; PPA, phenylpropanolamine; ED, emergency department; PICU, pediatric intensive care unit; CBC, complete blood (cell) count; WBC, white blood cell (count); bpm, beats per minute; AAP, American Academy of Pediatrics; CNS, central nervous system; FDA, Food and Drug Administration. C olds, 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. 1 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, 2-6 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. 7,8 We present 3 cases of children who suffered significant morbidity from OTC cough and cold preparations requiring admission and treatment in a tertiary care hospital during a 13-month period; they ranged from a self-limited reaction requiring an intensive care unit admission to death in 1 patient. Because no cases of death or heart failure attributable to OTC cough and cold preparations have been reported in recent literature, these cases are presented to serve as points for additional discussion on the risks of OTC cough and cold preparations in children. CASE REPORTS Case 1A 36-month-old b...

Unintentional Pediatric Ophthalmic Tetrahydrozoline Ingestion: Case Files of the Medical Toxicology Fellowship at the University of California, San Francisco

“…Drugs that can cause bradycardia with hypertension include phenylpropanolamine (PPA) [34], phenylephrine [35], and sometimes pseudoephedrine [10]. The mechanism is probably vagally mediated reflex bradycardia due to systemic hypertension.…”

“…Although screening for methadone and oxycodone was included in addition to the opiate urine immunoassay, other synthetic or semisynthetic opioids could have been involved, which might remain undetected. Other drugs that can cause drowsiness and small pupils include benzodiazepines, barbiturates, antipsychotics, other CNS depressants, clonidine, and other imidazoline derivatives [7][8][9][10][11].…”

What is the evidence for the safety and efficacy of over-the-counter cough and cold preparations for children younger than six years of age?

“…There are also factors, aside from adverse effects profiles, that further complicate dosing in children and may contribute to morbidity and mortality. First, caregivers have been found to make dosing errors in attempts to follow 'package guidelines' by misunderstanding the dose required or frequency, using an incorrect measuring device or even giving the wrong preparation (5). Also, the use of several products in an attempt to alleviate symptoms in their child can lead caregivers to overdose their children with certain ingredients due to combination preparations; in some cases, caregivers are not even aware of the active ingredients they are giving, due to small lettering and creative labelling of packages (5).…”

“…First, caregivers have been found to make dosing errors in attempts to follow 'package guidelines' by misunderstanding the dose required or frequency, using an incorrect measuring device or even giving the wrong preparation (5). Also, the use of several products in an attempt to alleviate symptoms in their child can lead caregivers to overdose their children with certain ingredients due to combination preparations; in some cases, caregivers are not even aware of the active ingredients they are giving, due to small lettering and creative labelling of packages (5). In addition, some combination products contain agents such as ibuprofen or acetaminophen that are also widely available in single-ingredient preparations, increasing the possibility of confusion and inadvertent administration of supratherapeutic doses.…”

“…Numerous evidencebased reports, including several systematic reviews of the literature in this area (5)(6)(7)(8)(9)(10)(11), have stated otherwise. In fact, each of the classes of drugs included in these formulations has its own list of associated adverse effects (Table 1) and they often coincide, increasing the danger inherent in combination medications that include many of these preparations (5,6). Furthermore, the active ingredient in these formulations can actually be changed by the manufacturer without any change to the brand name of the product (12), which is often what parents use to differentiate medications.…”