Pediatric Fatalities Associated With Over-the-Counter Cough and Cold Medications.

BACKGROUND AND OBJECTIVES: In 2008, over-the-counter cough and cold medications (CCMs) underwent labeling changes in response to safety concerns, including fatalities, reported in children exposed to CCMs. The objective of this study is to describe fatalities associated with exposures to CCMs in children <12 years old that were detected by a safety surveillance system from 2008 to 2016. METHODS: Fatalities in children <12 years old that occurred between 2008 and 2016 associated with oral exposure to one or more CCMs were identified by the Pediatric Cough and Cold Safety Surveillance System. An expert panel reviewed all cases to determine the causal relationship between the exposure and death, if the intent of exposure was therapeutic, and if the dose was supratherapeutic. Other contributing factors related to the child's death were also identified as part of a root cause analysis. RESULTS: Of the 180 eligible fatalities captured during the study period, 40 were judged by the expert panel to be either related or potentially related to the CCM. Of these, the majority (n = 24; 60.0%) occurred in children <2 years old and involved nontherapeutic intent (n = 22; 55.0%). The most frequently involved index ingredient was diphenhydramine (n = 28; 70.0%). In 6 cases (n = 6; 15.0%), the CCM was administered to murder the child. In another 7 cases (n = 7; 17.5%), death followed the intentional use of the CCM to sedate the child. CONCLUSIONS: Pediatric fatalities associated with CCMs occurred primarily in young children after deliberate medication administration with nontherapeutic intent by a caregiver.

Toxicity of over-the-counter cough and cold medications.

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.

Cardiomyopathy induced by phenylpropanolamine.

A 14-year-old girl had evidence of an acute cardiomyopathy after a minimal overdose of phenylpropanolamine. She had myocardial dysfunction, ventricular dysrhythmia, and secondary pulmonary edema without any associated systemic hypertension. The cardiomyopathy resolved after several days.

Adverse effect of intraoperative phenylephrine 10%: case report.

The case is reported of a patient who suffered severe acute hypertension, cardiac arrhythmia, and myocardial infarction probably as a direct effect of phenylephrine overdose. Instillation of the drops during surgery probably enhanced the systemic absorption of a significant amount of the drug. Therefore it should be used during surgery with caution, especially in elderly patients and those with cardiovascular disease.

Atrioventricular block following overdose of decongestant cold medication.

A 24-year-old man developed high-degree atrioventricular (A-V) block with a pulse rate of 40 beats per minute and hypertension following an overdose of a combination decongestant cold medication that contained phenylpropanolamine, phenylephrine, chlorpheniramine, and phenyltoloxamine. The patient was treated with ipecac, activated charcoal, and cathartics in the emergency department (ED). After his admission to the coronary care unit, the A-V block gradually resolved to sinus rhythm with periods of second-degree block, Mobitz types I and II. No treatment was required. The patient had a normal sinus rhythm and normal blood pressure prior to discharge.

Delayed fatal outcome after possible Ru-Tuss overdose.

Death resulted from the delayed onset of the acute respiratory distress syndrome and disseminated intravascular coagulation with left ventricular mural thrombus formation and nonbacterial thrombotic endocarditis approximately five days after an alleged attempted suicide by the ingestion of ten to twelve prolonged-action Ru-Tuss tablets. Although these lesions are thought to be similar in pathogenesis, this combination has not been previously reported in association with a drug overdose. The delay in onset is also of interest because of its clinical implications.