The number of overdoses is climbing in children under 5, who accidentally ingest the drug, and in kids 10 years and older who misuse the cough suppressant on purpose; the findings were published in the December 2022 issue of Pediatrics, published online November 15. “The most significant finding in our study is that drug safety considerations extend beyond the safe and appropriate use of prescription medication,” says the lead author, Ivone Kim, MD, a senior physician at the FDA. “Accessibility to benzonatate at home may present a risk for unintentional ingestion in young children. In older children and adolescents, access to benzonatate may lead to the misuse or abuse of these products, including the use in suicide attempts,” says Dr. Kim. Signs of benzonatate overdose may include restlessness, tremors, seizures, passing out, or heart attack, and potentially death, according to the FDA.

Pediatric Prescriptions for Benzonatate Have Increased Significantly

Investigators used several available databases to look at trends in the use of the cough suppressant. They found pediatric prescriptions for benzonatate increased 62 percent from 2012 to 2019, an increase that may be due to efforts to reduce inappropriate narcotic prescriptions. Benzonatate still made up only about 10 percent of pediatric antitussive medication prescriptions in 2019, while 90 percent were for dextromethorphan-containing medications. Dextromethorphan, commonly referred to as DXM, is a cough suppressant found in more than 120 over-the-counter cold medications, and it’s typically found in extra-strength cough syrups, tablets and gel capsules, according to American Addiction Centers. Since at least 2010, the FDA has warned that the accidental ingestion of benzonatate by kids under 10 could cause death.

Reports of Children Ingesting the Cough Medicine Jumped 159 Percent Over 8 Years

Researchers found a total of 4,689 cases of benzonatate overdose or misuse, including 6 deaths, between 2010 and 2018. Reports to U.S. poison control centers of children ingesting the drug jumped 159 percent during the eight-year period, from 308 cases in 2010 to 799 in 2018, the study found. The cases include very young children unintentionally exposed to the drug as well as children age 10 and older who misused it intentionally. About 77 percent of benzonatate exposures reported to poison control were unintentional. These exposures rose from 256 in 2010 to 581 in 2018, and most involved children younger than 6 years, according to the study. “The data suggests that access to benzonatate presents a risk for unintentional ingestion in young children, as oral exploration is a normal part of development in infants, and young children may be enticed to consume objects that resemble candy,” says Kim.

Cough Medicine Used in Suicide Attempts in Children and Teens

Intentional exposures rose from 49 in 2010 to 210 in 2018, with just over half of misuse or abuse cases and nearly all suspected suicide attempts occurring among children ages 10 to 16, according to the authors. They noted that exposures and deaths reported in the study likely are an undercount, and they could not discern how benzonatate overdose severity compared with other cough medications.

Expert Tips on Drug Safety

It is important for parents to discuss drug safety for all prescribed medications with their medical providers, says Kim. “Drug safety includes understanding appropriate dosing, administration, reasons for prescription, and learning about potential side effects of the medication,” she says. All medications should have the safety cap on, they should be kept in their original packaging so there’s no confusion about what they are, and they should be kept out of reach of young children — especially toddlers, says Joanna Cohen, MD, an associate professor of pediatrics at Johns Hopkins Medicine in Baltimore. Parents should be aware of symptoms of benzonatate toxicity (such as restlessness, tremors, convulsions, or coma) and seek prompt medical care, says Kim. “Parents and caretakers may also want to be familiar with how to properly dispose of unused medications at home,” she says. For more information on proper drug disposal, visit the FDA’s website.