FDA warns of rise in reports of child poisonings linked to cough medicine
1 / 2 FDA warns of rise in reports of child poisonings linked to cough medicine FDA Berkeley Lovelace Jr. Tue, November 15, 2022 at 8:01 AM Poison control centers in the U.S. have seen an increase in reports of children ingesting a type of prescription cough medicine, a study published Tuesday by the Food and Drug Administration found.
From 2010 through 2018, reports of pediatric poisonings involving the drug, benzonatate, increased each year, the study found. Benzonatate, sold under the brand name Tessalon, is prescribed to treat coughs caused by colds or the flu. It is not approved for children younger than 10 years old.
The findings, published in the journal Pediatrics, were based on more than 4,600 cases reported to poison control centers. The biggest increase — 24% — was from 2015 to 2016.
The reports included children who were unintentionally exposed to the drug, as well as children who abused or misused it intentionally.
Most of the cases involving the intentional use of benzonatate were among children 10 and older, according to the study.
The proportion of cases with serious adverse effects was low. However, accidental or inappropriate use of benzonatate, which comes in gel capsules, can lead to serious health problems in children, including convulsions, cardiac arrest and death.
The findings should galvanize doctors to be more careful when they prescribe these kinds of medications, said study author Dr. Ivone Kim, a pediatrician and senior medical officer at the FDA.
It should also encourage more parents to keep their prescriptions out of the reach of children, said Dr. Nusheen Ameenuddin, a pediatrician at the Mayo Clinic in Rochester, Minnesota.
Cough medications "should be treated like any other medication that can have serious side effects," Ameenuddin said, "which means not giving it to children without specific medical direction."
Drugmakers may also need to reassess how the drug is manufactured, she added, because in comes in round liquid-filled capsules that resemble candy, making it attractive to children.
The rise in pediatric poisonings involving benzonatate coincided with an increase in the number of prescriptions that were filled for the drug over the same period.
-yahoo news