Analysis of Benzonatate Overdoses Among Adults and Children from 1969–2010 by the United States Food and Drug Administration

  title={Analysis of Benzonatate Overdoses Among Adults and Children from 1969–2010 by the United States Food and Drug Administration},
  author={Melinda W McLawhorn and Margie Rauch Goulding and Rajdeep Gill and Theresa M. Michele},
  journal={Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy},
To augment the December 2010 United States Food and Drug Administration (FDA) Drug Safety Communication on accidental ingestion of benzonatate in children less than 10 years old by summarizing data on emergency department visits, benzonatate exposure, and reports of benzonatate overdoses from several data sources. 

Impact of a drug safety communication on the severity of benzonatate exposures reported to poison centers

Identify if publication of the 2010 drug safety communication (DSC) regarding benzonatate was associated with a decrease in the incidence of severe benzonatate poisonings reported to United States

Benzonatate Exposure Trends and Adverse Events.

Rational prescribing and improved provider and caregiver awareness of benzonatate toxic effects may reduce risks associated with benzon atate exposure.

Management of Acute Cough in Children: Where Do We Go From Here?

Honey and topical use of aromatic oils have limited evidence of efficacy, but may have the greatest margin of safety for treatment of acute cough in children.

Pediatric post‐marketing safety systems in North America: assessment of the current status

It is critical to have pediatric post‐marketing safety systems that contain enough clinical and epidemiological detail to draw regulatory, public health, and clinical conclusions. The pediatric

A description of the clinical course of severe benzonatate poisonings reported in the literature and to NPDS: A systematic review supplemented with NPDS cases

Overdose ingestions of benzonatate can cause significant toxicity with a rapid onset, but duration of directly toxic effects is short, but dramatic with neurologic devastation and resuscitated patients often still have a poor outcome.

Arrhythmogenic Antitussive: A Case of Pediatric Benzonatate Overdose With Torsades de Pointes, Cardiac Arrest, and Complete Recovery Without Neurologic Deficits.

The case of a 14-year-old female who ingested 14 capsules containing 200 mg benzonatate with torsades de pointes is reported, which represents the only reported benzoneatate overdose with torches de pointe, as well as theonly reported pediatric benzon atate ingestion complicated by cardiac arrest with full recovery.

Central nervous system toxicity.

  • A. RuhaM. Levine
  • Medicine, Psychology
    Emergency medicine clinics of North America
  • 2014

Presence of “One Pill Can Kill” Medications in Medication Organizers: Implications for Child Safety

The majority of dispensed medication organizers included 1PCK medications, which may cause toxicity even with a single tablet, and patients should be questioned for possible proximity exposures.

A 17-Year-Old Girl With Cough—Pulseless After Drug Overdose

An 17-year-old girl with a history of depression, but no prescribed antidepressants, arrives to the emergency department (ED) in cardiac arrest after swallowing 12 tablets of a medication, rapidly developed generalized convulsions and then became apneic.

Cardiac Arrest Due to Benzonatate Overdose

Ingestion of benzonatate, a widely prescribed antitussive, may pose a risk to patients due to the potential for rapid development of life-threatening adverse events and limited treatment options in the overdose setting, not only in children but also in adults.



Use of codeine- and dextromethorphan-containing cough remedies in children. American Academy of Pediatrics. Committee on Drugs.

Education of patients and parents about the lack of proven antitussive effects of cough and cold preparations and the potential risks of these products is needed.

Benzonatate Ingestion Reported to the National Poison Center Database System (NPDS)

A median dose of 200 mg or greater suggests a potential for producing serious outcomes in a benzonatate exposure and a prospective study to better evaluate potential HCF triage criteria such as dosage, age, or preexisting conditions may be warranted.

Two fatalities resulting from Tessalon (benzonatate).

Two fatal cases involving Tessalon (benzonatate) were quantitated by ultraviolet (UV) and high performance liquid chromatography (HPLC) and believed to be the first reported cases involving this compound.

Benzonatate overdose associated with seizures and arrhythmias.

Seizures and cardiac arrest are possible following an acute ingestion of benzonatate and an analytical method to identify and quantify benzon atate in human plasma is reported.

An empiric integrative approach to the management of cough: ACCP evidence-based clinical practice guidelines.

Algorithms that provide a "road map" that the clinician can follow are useful and are presented for acute, subacute, and chronic cough.

Evaluation and Overview of the National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance Project (NEISS-CADES)

Assessment of the performance of the National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance project (NEISS-CADES) from January 1, 2004 through December 31, 2004 shows detailed and timely information on outpatient ADEs treated in EDs and identifies specific drugs and circumstances associated with these injuries.

2008 Annual Report of the American Association of Poison Control Centers’ National Poison Data System (NPDS): 26th Annual Report

The near real-time, always current status of NPDS represents a national resource to collect and monitor US poisoning exposure cases and information calls, providing a model public health surveillance system for all types of exposures, public health event identification, resilience response and situational awareness tracking.

The pharmacology of cough.

Tessalon (benzonatate) package insert

  • Available from Accessed March
  • 2010