Benzonatate Cough Medicine Poisonings Among Children Increased Each Year Between 2010 and 2018: Study

Benzonatate cough medicine poisonings can cause children to stop breathing if misused, the FDA warns

A new study highlights the growing problem with childhood poisonings from cough medicines containing benzonatate, which is sold under the brand name Tessalon, indicating that poison control centers throughout the U.S. have seen an increasing number of exposures reported in recent years, which may lead to seizures, cardiac arrest and death in severe cases.

Between 2010 and 2018, the number of children ending up in emergency rooms after accidentally or knowingly ingesting the prescription cough medicine increased each year, according to researchers with the U.S. Food and Drug Administration (FDA).

In a report published this week in the journal Pediatrics, researchers conducted a retrospective analysis of data from IQVIA pharmacy drug dispensing, the National Poison Data System, the National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance Project, the FDA Adverse Event Reporting System, and medical literature evaluated exposure trends and medication-related adverse events with benzonatate.

Benzonatate was first approved by the FDA in 1958, for children over the age of 10. It suppresses the cough reflex in the lungs. This same mechanism, if misused, can cause children to stop breathing completely.

Prescriptions for pediatric Tessalon increased by 62% between 2010 and 2018, but remained low compared with prescriptions for dextromethorphan, another type of cough medication. However, the study suggests that as prescriptions increased, children suffering from poisonings also increased.

Researchers evaluated more than 4,600 pediatric exposure cases reported to U.S. poison control centers during the study period, and found that reports of Tessalon poisoning among children increased every year, with the greatest increase of 24% occurring from 2015 to 2016. More than 80% of cases involved children under the age of 5 years old. While 77% of poisonings were unintentional, cases of children intentionally abusing or misusing the medication increased among children ages 10 to 16 years old, especially for multiple substance exposures.

“There were rising patterns of unintentional ingestion of benzonatate in children 0 to 5 years old and intentional benzonatate ingestion in children 10 to 16 years old,” FDA researchers wrote. “Rational prescribing and improved provider and caregiver awareness of benzonatate toxic effects may reduce risks associated with benzonatate exposure.”

Tessalon Cough Medicine Poisoning Risks

Despite the increases in poisonings the rate of serious side effects was low. However, there were several cases each year of serious adverse events. These cases included seizures, respiratory arrest, cardiac arrest, electrolyte imbalances, and death.

Researchers warn the findings should encourage doctors to take care when prescribing cough medications which can harm children. Parents and caregivers must keep prescription medications out of the reach of children, researchers and poison centers warn.

The look and design of these types of medications may need to be reassessed by drugmakers, researchers noted. The cough medicine is sold as a round liquid-filled gel capsule that closely resembles candy and is visually appealing to young children.

Overall, benzonatate is an appealing alternative to other cough medications because it is non-narcotic. As prescriptions for benzonatate increased among children, prescriptions for cough medicines containing narcotics, like codeine, decreased. But the increase in side effects and misuse should have doctors and parents considering its dangers and prescribing it more cautiously.