Intoxicación grave con nafazolina: puesta al día a partir de un error terapéutico / Severe poisoning with naphazoline: update from a therapeutic error

La nafazolina es un fármaco utilizado como descongestivo, generalmente, en pacientes adultos. Su indicación en pediatría no es frecuente; su uso está aprobado a partir de los 12 años por los efectos tóxicos que posee. La intoxicación en niños genera un cuadro clínico potencialmente grave. Se caracteriza por la aparición inmediata de hipotonía, deterioro del sensorio, hipotermia y bradicardia con grado variable de compromiso clínico. Si bien es una intoxicación infrecuente, la anamnesis y el manejo inicial del paciente son la clave en su evolución. Se presenta a un niño de 4 años que, por un error terapéutico, recibió este fármaco y se destaca la instauración rápida y potencialmente grave del cuadro clínico.

Naphazoline is a drug commonly used as a decongestant in adult patients. Its indication in Pediatrics is not frequent, being approved its use from the age of 12 for the toxic effects it possesses. Intoxication in children generates a potentially serious clinical picture. It is characterized by the immediate appearance of hypotonia, deterioration of the sensory, hypothermia and bradycardia of variable degree of clinical compromise. Although it is an infrequent intoxication, the anamnesis and the initial management of the patient are the key in the evolution. We present a 4-year-old boy who, as a therapeutic error, receives this drug, emphasizing the rapid and potentially severe establishment of the clinical picture.

[Severe poisoning with naphazoline: update from a therapeutic error]. / Intoxicación grave con nafazolina: puesta al día a partir de un error terapéutico.

Naphazoline is a drug commonly used as a decongestant in adult patients. Its indication in Pediatrics is not frequent, being approved its use from the age of 12 for the toxic effects it possesses. Intoxication in children generates a potentially serious clinical picture. It is characterized by the immediate appearance of hypotonia, deterioration of the sensory, hypothermia and bradycardia of variable degree of clinical compromise. Although it is an infrequent intoxication, the anamnesis and the initial management of the patient are the key in the evolution. We present a 4-year-old boy who, as a therapeutic error, receives this drug, emphasizing the rapid and potentially severe establishment of the clinical picture.

La nafazolina es un fármaco utilizado como descongestivo, generalmente, en pacientes adultos. Su indicación en pediatría no es frecuente; su uso está aprobado a partir de los 12 años por los efectos tóxicos que posee. La intoxicación en niños genera un cuadro clínico potencialmente grave. Se caracteriza por la aparición inmediata de hipotonía, deterioro del sensorio, hipotermia y bradicardia con grado variable de compromiso clínico. Si bien es una intoxicación infrecuente, la anamnesis y el manejo inicial del paciente son la clave en su evolución. Se presenta a un niño de 4 años que, por un error terapéutico, recibió este fármaco y se destaca la instauración rápida y potencialmente grave del cuadro clínico.

Not Just a Drop in the Bucket-Inversion of Oxymetazoline Nasal Decongestant Container Increases Potential for Severe Pediatric Poisoning.

Oxymetazoline is an over-the-counter nasal decongestant with potent alpha agonist properties. In overdoses as small as 1-2 mL, toxicity can be seen including bradycardia and respiratory depression. We demonstrated that inverting the container increased the volume delivered 20- to 30-fold compared with holding it upright in an in vitro model.

Xylometazoline poisoning: A 40-fold nasal overdose caused by a compounding error in 3 children.

The imidazoline derivative xylometazoline, an alpha-2-adrenergic agonist, is used as non-prescription nasal preparation due to its vasoconstrictive and decongestive properties. Especially in children, an overdose can quickly cause severe central nervous system depression and cardiovascular adverse effects. In three 3-year-old boys (triplets) a xylometazoline intoxication was diagnosed by toxicological analysis. On admission to an emergency unit all three children were still unresponsive. One triplet showed respiration of 15-20 breaths/min and required oxygen support (3L/min) via face mask; his electrocardiogram revealed sinus bradycardia of 64 beats/min with supraventricular extrasystoles. However, no interventions were necessary except fluid management via intravenous lines. Eleven hours after the event, two of the triplets were awake but still not fully oriented. The third triplet woke up 20h after instillation of nose drops. Intoxication was caused by a compounding error in a pharmacy resulting in a concentration 40 times above the adequate dosage for children. In general, physicians, pharmacists and the public should be educated about the toxicity of over-the-counter preparations.

Effect of cough and cold medication restriction and label changes on pediatric ingestions reported to United States poison centers.

OBJECTIVE: To determine the impact of industry and Food and Drug Administration initiatives implemented to limit the use of over-the-counter (OTC) cough and cold medications in children younger than 6 years of age. STUDY DESIGN: This is a retrospective database study of OTC cough and cold medication ingestions reported to US poison centers between 2000 and 2010. Data analyzed from the National Poison Data System included the month and year of ingestion, reason for ingestion, health care utilization, and medical outcome. Ingestion frequencies were stratified by age and reason. Data were divided into pre- and postintervention periods for comparative analysis. RESULTS: Unintentional ingestions of OTC cough and cold medications decreased 33.4% and therapeutic errors by 46.0%. Health care facility referral declined for unintentional ingestions (28.9% <2 years of age, 19.9% 2-5 years of age, P < .0001) and therapeutic errors in children younger than 2 years of age (59.2%, P < .0001). Moderate and severe adverse outcomes decreased for unintentional ingestions in children younger than 2 years of age by 32.4% and by 21.3% in 2- to 5-year olds, P < .0001. CONCLUSIONS: The restriction of OTC cough and cold medications has led to a decline in unintentional ingestions, therapeutic errors, health care facility referral, and serious medical outcomes in children younger than 2 years of age. There has also been a decline in ingestions in 2- to 5-year-old children.

Restricting cough and cold medicines in children.

AIMS: Based on concerns about safety and efficacy, international authorities have either advised against the use of cough and cold medication or considering such action. We aimed to systematically review the evidence for the effectiveness and safety of cough and cold medicines in children. METHODS: We conducted a systematic review to identify studies relating to the use of products to treat symptoms of the common cold, influenza or allergic rhinitis, and relating to poisoning or toxicity from unintentional ingestion or overdose in children (<12 years). Medline, Embase and the Cochrane database were searched. No meta-analysis was undertaken because of the paucity of evidence, multiple medicines available, and the need to consider both effectiveness and safety. RESULTS: Seventy two relevant studies or clinical reports were identified. There was little support for the effectiveness of these medicines for acute cough or the common cold in children. However, the majority of these medicines do not appear to be highly toxic in children and are not a major cause of severe effects following unintentional poisoning. The common use of these agents does not appear to be responsible for increased deaths in young children. Many cases of toxicity from cough and cold medications in young children are a result of therapeutic error. Particular medications, including diphenhydramine and codeine, appear to be associated with a high frequency of severe adverse effects and toxicity. CONCLUSION: Restriction of cough and cold medicines in children is supported by currently available evidence.

One drop can be beneficial, one swig can be deadly: tetrahydrozoline intoxication.

Tetrahydrozoline is a commonly used imidazoline derivative with serious side effects and toxicity, particularly in small children. A one-year-old boy was admitted to the emergency department (ED) after he accidentally ingested about half a bottle of nasal decongestant solution containing tetrahydrozoline. He was unconscious, hypothermic and bradycardic on presentation. His respiration was irregular and superficial, and blood pressure was borderline hypotensive. His skin was pale and cold. Atropine was administered twice for symptomatic bradycardia, and the child was transferred to the pediatric intensive care unit (PICU). During the 12th hour of observation, vital signs returned to normal and there was no need for mechanical ventilation. Although suitable room temperature with passive warming was applied, hypothermia continued for approximately 24 hours. The patient was discharged on the second day of admission. There were no complaints one week later, and the physical examination was normal. We report a case of accidental tetrahydrozoline intoxication with life-threatening events accompanying hypothermia in a small infant.

[Misuse of substances theoretically without abuse potential--case series]. / Naduzywanie substancji teoretycznie bez znanego potencjalu uzalezniajacego--przeglad przypadków.

The aim of our study was to present cases of misuse of different substances theoretically without abuse potential. In the last few years such behavior became an increasing problem in toxicological and emergency units. Lack of typical signs of intoxication with psychoactive substances, and negative results of standard toxicological tests may be a challenge for toxicologists and emergency medicine practitioners.

Pediatric fatalities associated with over the counter (nonprescription) cough and cold medications.

STUDY OBJECTIVE: The use of nonprescription cough and cold medicines is widespread, but their use has been sporadically associated with severe toxicity and death. We evaluate the role of these medications in pediatric fatalities and identified factors that contributed to the death. METHODS: Fatalities that involved a child younger than 12 years and mentioned a cough and cold ingredient were obtained from 5 sources. An independent panel of 8 experts (pediatrics, pediatric critical care, pediatric toxicology, clinical toxicology, forensic toxicology, forensic pathology) used explicit definitions to assess the causal relationship between medication ingestion and death. Contributing factors were identified. RESULTS: Of 189 cases included, 118 were judged possibly, likely, or definitely related to a cough and cold ingredient. Of these 118 cases, 103 involved a nonprescription drug, whereas 15 cases involved a prescription medication alone. Of 103 cases associated with nonprescription drugs, the evidence indicated that 88 involved an overdosage. A dosage could not be assessed in the remaining 15 cases. Several contributing factors were identified: age younger than 2 years, use of the medication for sedation, use in a daycare setting, use of 2 medicines with the same ingredient, failure to use a measuring device, product misidentification, and use of a nonprescription product intended for adult use. All cases that occurred in a daycare setting involved a child younger than 2 years. CONCLUSION: In our sample, pediatric fatalities caused by nonprescription cough and cold medications were uncommon, involved overdose, and primarily affected children younger than 2 years. The intent of caregivers appears to be therapeutic to relieve symptoms in some cases and nontherapeutic to induce sedation or to facilitate child maltreatment in other cases.

Revised product labels for pediatric over-the-counter cough and cold medicines.

October 7, 2008, the Consumer Healthcare Products Association announced that the leading manufacturers of pediatric over-the-counter cough and cold medicines would voluntarily modify the labels on these products to state that they should not be used in children aged <4 years.

Acute pulmonary edema associated with naphazoline ingestion.

In published reports of naphazoline ingestion, clinical effects are hypertension, bradycardia, pallor, diaphoresis, and respiratory distress. We report three cases of acute pulmonary edema after the intentional ingestion of naphazoline-containing antiseptic first aid liquid. These cases presented with altered mental status, hypertension, bradycardia, and diaphoresis. Chest x-ray on admission revealed acute pulmonary edema. Two cases required mechanical ventilation. All of these clinical effects resolved within 24 hours and the patients were discharged with no sequelae. Since naphazoline stimulates the peripheral alpha-2 adrenergic receptor, we speculate that intense vasoconstriction may have elevated cardiac afterload and left atrial-ventricular blood volume and caused acute pulmonary edema.

A case series of xylometazoline overdose in children.

INTRODUCTION: Serious intoxications associated with low doses of imidazolines have been reported. Therefore, the treatment advice for children with xylometazoline overdose is usually to observe the child in the hospital, even after exposure to very low doses. Our aim was to determine the frequency of severe symptoms after xylometazoline exposure, and the systemic dose of xylometazoline below which asymptomatic children do not need to be hospitalized for observation. METHODS: From May 2002 until December 2004, we prospectively collected data on all consecutive cases of xylometazoline exposure in children <6 years old reported to our poisons centre. Follow-up information was collected. The systemic dose was calculated and the frequency of severe symptoms was observed. RESULTS: During 32 months, we included 101 cases of xylometazoline exposure in children. For 63 out of these 101 cases, follow-up information could be collected. No severe symptoms were observed after exposure to xylometazoline doses reported to be below 0.4 mg/kg (95% confidence interval: 0-6%). CONCLUSION: We conclude that less than 6% of children exposed to xylometazoline, at doses reported to be less than 0.4 mg/kg body weight, may develop symptoms that require hospitalization.

Intoxicación accidental por descongestionante tópico nasal / Accidental intoxication due to a topical nasal decongestant

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[Acute exposure to imidazoline derivatives in children]. / Exposição aguda a derivados imidazolínicos em crianças.

OBJECTIVES: To study acute exposure to imidazoline derivatives in 72 children younger than 15 years of age, followed-up from January 1994 to December 1999. METHODS: This is a retrospective study of 72 patients with age between 2 months and 13 years (median 2 years; 25-75% = 1 to 3 years old) exposed to naphazoline (N = 48), fenoxazoline (N = 18), oxymetazoline (N = 5) and tetrahydrozoline (N = 1), through oral (N = 46), nasal (N = 24) or unknown (N = 2) routes. RESULTS: Fifty-seven children developed clinical manifestations such as somnolence (N = 34/57), sweating (N = 20/57), pallor (N = 17/57), hypothermia (N = 16/57), bradycardia (N = 13/57), cool extremities (N = 9/57), restlessness (N = 7/57), tachycardia (N = 6/57), vomiting (N = 5/57), irregular respiratory pattern and apnea (N = 5/57), miosis/mydriasis (N = 4/57). Naphazoline was the active ingredient most frequently involved (N = 47), followed by fenoxazoline (N = 5) and oxymetazoline (N = 4). The onset of clinical manifestations was rapid, beginning within 2 hours after exposure in 32/57 children. Only supportive measures were employed, with one child requiring mechanical ventilation after accidental naphazoline ingestion. In most of the children resolution of symptoms occurred within 24 hours (N = 39/57). No deaths were observed. Patients exposed to naphazoline (N = 47/48) presented a higher frequency of clinical signs of poisoning in comparison with those exposed to fenoxazoline (N = 5/18) (p < 0.001). There were no significant differences in the frequency of patients who presented clinical manifestations considering the route of exposure [oral (N = 34/46), nasal (N = 21/24); p = 0.31]. CONCLUSIONS: Most children (especially those younger than 3 years) exposed to imidazoline derivatives (especially naphazoline) presented early signs of poisoning regardless of the exposure route (nasal or oral). The main signs observed were nervous system, cardiovascular and respiratory depression. Most children showed complete resolution of the symptoms within 24 hours.