Cases of Child Poisonings Linked to Cough Medicine on the Rise: Report

A cough medication is poured in this picture illustration taken on Oct. 19, 2022. Ajeng Dinar Ulfiana/Reuters

A rise in reports of child poisonings linked to the prescription cough medicine benzonatate has been found across the United States in recent years, according to a study conducted by the Food and Drug Administration (FDA).

The study, titled “Benzonatate Exposure Trends and Adverse Events,” was published Tuesday by the American Academy of Pediatrics.

Researchers analyzed data from IQVIA pharmacy drug dispensing, the National Poison Data System, National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance Project, and the FDA’s Adverse Event Reporting System.

They found that reports of pediatric poisonings involving benzonatate across the country increased every year from 2010 through 2018, based on reports from poison control centers.

That coincided with an increase in the number of prescriptions that were filled for the cough medicine during that same period, according to the study.

The study found that reports of child poisonings involving the drug included those who were unintentionally exposed to the cough medicine as well as those who intentionally abused or misused it.

‘Rising Patterns of Unintentional Ingestion of Benzonatate’

Among the 4,689 pediatric benzonatate exposure cases reported to U.S. poison control centers from 2010 to 2018, 3,727 cases, or 80 percent, were for single-substance exposures.

Of these, 3,590 cases, or 77 percent, were unintentional exposures, and 2,718 cases, or 83 percent, involved children 5 years old and younger, researchers said.

The majority of cases involving the intentional use of benzonatate were among children 10 and older, according to the study.

“Cases involving intentional benzonatate exposure increased among children 10 to 16 years old with a more pronounced increase for multiple-substance exposures,” the study authors wrote. “Most benzonatate cases involving misuse or abuse were for children 10 to 16 years old (59 cases, 61 percent). The proportion of cases with serious adverse effects was low.”

Researchers concluded: “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. Rational prescribing and improved provider and caregiver awareness of benzonatate toxic effects may reduce risks associated with benzonatate exposure.”

The study authors did note that there were limitations to their research, including that they were not able to confirm every case reported to poison control centers and that some of those cases may have been duplicates.

Benzonatate ‘May Be Attractive to Children’

Benzonatate is a prescription drug used to treat coughs caused by the common cold as well as other breathing problems such as asthma and bronchitis.

The drug is sold under the brand name Tessalon, which is manufactured by Pfizer Inc.

It was approved by the FDA in 1958 for use in patients over 10 years of age but its safety and effectiveness in children under the age of 10 has not yet been established.

The FDA notes that benzonatate “may be attractive to children because of the drug’s appearance (it is a round-shaped liquid-filled gelatin capsule),” which resembles candy.

Overdoses of benzonatate can result in health issues such as convulsions, coma, and cardiac arrest, according to the FDA. Signs and symptoms can appear within 15 to 20 minutes of ingestion while deaths in children have been reported within hours of accidentally ingesting the drug, according to the FDA.

Cough medications “should be treated like any other medication that can have serious side effects,” Dr. Nusheen Ameenuddin, a pediatrician at the Mayo Clinic in Rochester, Minnesota, told NBC News. Ameenuddin added that this means “not giving it to children without specific medical direction.”

The FDA recommends keeping benzonatate in a child-resistant container and storing it out of reach of children at all times. In cases where a child accidentally ingests benzonatate, parents and caregivers are advised to contact the Poison Control Center and seek immediate medical attention.

The Epoch Times has contacted Pfizer for comment.