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.

Cardiovascular Complications of Opioid Use: JACC State-of-the-Art Review.

Opioids are the most potent of all analgesics. Although traditionally used solely for acute self-limited conditions and palliation of severe cancer-associated pain, a movement to promote subjective pain (scale, 0 to 10) to the status of a "fifth vital sign" bolstered widespread prescribing for chronic, noncancer pain. This, coupled with rising misuse, initiated a surge in unintentional deaths, increased drug-associated acute coronary syndrome, and endocarditis.

Trends in adverse events and related health-care facility utilization from cough and cold medication exposures in children.

Introduction: Initial research following regulatory changes addressing the pediatric safety of cough and cold medications (CCMs) demonstrated decreases in adverse events (AEs). Using a national multi-source surveillance system, we studied subsequent CCM-related AE case rate trends and associated health-care facility (HCF) evaluation in children.

Methods: Data were collected from 2009 to 2016.

Adverse Events Related to Accidental Unintentional Ingestions From Cough and Cold Medications in Children.

Objectives: Previous research has demonstrated that accidental unsupervised ingestions (AUIs) were responsible for the majority of cough and cold medication (CCM) ingestions leading to significant adverse events (AEs) in children. The objective of this analysis was to characterize the role of AUIs in the morbidity associated with CCM exposure in children.

Methods: This surveillance study collected data from 5 United States data sources from 2009 to 2016, in children younger than 6 years with an AE from an AUI involving at least 1 CCM over-the-counter pharmaceutical ingredient.

Medication Errors From Over-the-Counter Cough and Cold Medications in Children.

Objective: Out of hospital medication-related adverse events (AEs) from cough and cold medications (CCMs) can have significant public health impact. The objective of this study was to characterize pediatric medication error AEs involving over-the-counter (OTC) CCMs to identify preventable factors.

Methods: Multisource national data surveillance system study using an expert panel evaluating CCM AEs related to medication errors.

Adverse events associated with diphenhydramine in children, 2008-2015.

Diphenhydramine (DPH) exposures in children may be the result of accidental unsupervised ingestions, caregiver error, and intentional misuse of DPH-containing cough and cold medications (CCM). We sought to understand the nature of pediatric ingestions of DPH, particularly the toxicity and outcome of a single product, single ingredient DPH (DPH-only) exposures, in order to derive ingredient-specific information about the clinical effects and course of such cases. As part of a U.

Evaluation of the quality and value of data sources for postmarket surveillance of the safety of cough and cold medications in children.

Background: The purpose of this report is to evaluate the quality of data sources used to study cough and cold medication (CCM) safety in children via the Pediatric Cough and Cold Safety Surveillance System.

Methods: The System utilized the National Poison Data System (NPDS), FDA Adverse Event Reporting System (FAERS), English-language medical literature, manufacturer postmarket safety databases, and news/media reports to identify cases from January 2008 through September 2016. Each data source was evaluated by the proportion of detected cases determined to be eligible (met case criteria) and the proportion determined to be evaluable (able to determine causal relationship between adverse event and exposure).

Safety Profile of Cough and Cold Medication Use in Pediatrics.

Background And Objectives: The safety of cough and cold medication (CCM) use in children has been questioned. We describe the safety profile of CCMs in children <12 years of age from a multisystem surveillance program.

Methods: Cases with adverse events (AEs) after ingestion of at least 1 index CCM ingredient (brompheniramine, chlorpheniramine, dextromethorphan, diphenhydramine, doxylamine, guaifenesin, phenylephrine, and pseudoephedrine) in children <12 years of age were collected from 5 data sources.

Adverse events associated with pediatric exposures to dextromethorphan.

Study Objective: Dextromethorphan is the most common over-the-counter (OTC) antitussive medication. We sought to characterize adverse events associated with dextromethorphan in children <12 years old from a surveillance program of OTC cough/cold medication exposures.

Methods: This is a retrospective case series of oral exposures to dextromethorphan with ≥1 adverse event from multiple U.

Fatal fentanyl patch misuse in a hospitalized patient with a postmortem increase in fentanyl blood concentration.

Opioid-related mortality happens, even in healthcare settings. We describe serial postmortem fentanyl blood concentrations in a hospital inpatient who fatally abused transdermal fentanyl. This is a single-patient case report.

Fentanyl in postmortem forensic toxicology.

Context: Fentanyl is a powerful opioid used for the induction of anesthesia as well as for the management of severe pain. In recent years, transdermal fentanyl "patches" have become popular for outpatient management of chronic pain. The high potency and outpatient availability of fentanyl has also made it a highly sought-after drug of abuse.

Massive ethylene glycol ingestion treated with fomepizole alone-a viable therapeutic option.

Fomepizole is used to treat and prevent toxicity from ethylene glycol poisoning. Treatment with fomepizole without hemodialysis in massive ethylene glycol ingestion has been rarely reported in the literature; however, published literature and practice guidelines recommend considering dialysis for ethylene glycol levels >50 mg/dL. We report a case of massive ethylene glycol ingestion resulting in the highest serum ethylene glycol concentration in a patient without ethanol co-ingestion who was treated with fomepizole and was not hemodialyzed.

A review of the use of ethyl glucuronide as a marker for ethanol consumption in forensic and clinical medicine.

Ethyl glucuronide (EtG) is a direct phase-II metabolite of ethanol formed through the UDP-glucuronosyl transferase catalyzed conjugation of ethanol with glucuronic acid. It has been detected in many antemortem and postmortem biological matrices using a variety of analytical methods. Due to its long urinary elimination time, detectability in hair, specificity for ethanol exposure, and low detection limits of assays, the use of EtG has been proposed as a marker of recent ethanol intake in a variety of clinical and legal settings, including medical monitoring for relapse, emergency department patient evaluation, postmortem assessments, and transportation accident investigation.

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.

Epidemiology, toxicokinetics, and health effects of methyl tert-butyl ether (MTBE).

This paper reviews the published information assessing the kinetics and potential for adverse health effects related to exposure to the fuel oxygenate, methyl tert-butyl ether (MTBE). Data were obtained from previously published reports, using human data where possible. If human data were not available, animal studies were cited.

Derivation of a chemical-specific adjustment factor (CSAF) for use in the assessment of risk from chronic exposure to ethylene glycol: application of International Programme for Chemical Safety guidelines.

The International Programme for Chemical Safety (IPCS) has developed a set of guidelines ("the Guidance") for the establishment of Chemical-Specific Adjustment Factors (CSAFs) for in the assessment of toxicity risk to the human population as a result of chemical exposure. The development of case studies is encouraged in the Guidance document and comments on them have been encouraged by the IPCS. One provision in the Guidance is for the determination of CSAFs based on human data.

Solvents and vapor intrusion pathways.

Vapor intrusion must be recognized appropriately as a separate pathway of contamination. Although many issues resemble those of other forms of contamination (particularly its entryway, which is similar to that of radon seepage), vapor intrusion stands apart as a unique risk requiring case-specific action. This article addresses these issues and the current understanding of the most appropriate and successful remedial actions.

Gamma-butyrolactone and 1,4-butanediol: abused analogues of gamma-hydroxybutyrate.

gamma-Hydroxybutyrate (GHB) is a GABA-active CNS depressant, commonly used as a drug of abuse. In the early 1990s, the US Drug Enforcement Administration (DEA) warned against the use of GHB and restricted its sale. This diminished availability of GHB caused a shift toward GHB analogues such as gamma-butyrolactone (GBL) and 1,4-butanediol (1,4-BD) as precursors and surrogates.

Improvement in irritable bowel syndrome following ano-rectal surgery.

Background And Aims: To assess the effect on irritable bowel syndrome (IBS) of treating ano-rectal problems by applying multiple Barron's bands to prolapsing mucosa and excising haemorrhoids, with or without a low lateral sphincterotomy.

Patients And Methods: 144 patients with IBS whose ano-rectal abnormalities were treated by a single consultant surgeon. A prospective "within person" study of consecutive patients referred with ano-rectal problems who also had IBS symptoms according to the Rome criteria.