Warning over surge in reports of child cough medicine poisonings: FDA urged careful prescribing

There has been a marked increase in the number of children being poisoned by a specific type of cough medicine, health officials have warned.

Benzonatate – sold under the brand name Tessalon – comes in gel capsules which researchers fear are enticing to minors and easily mistaken for candies.

From 2010 to 2018, reports of pediatric poisonings involving the drug increased each year by an average of about 13 percent.

The steepest jump occurring between 2015 and 2016 at 24 per cent. There were five deaths across the eight year span.

Of the roughly 4,700 reports to poison control centers, three-quarters were unintentional exposures, and most involved children five years old and younger.

The rise in poisonings is in line with the increase in prescriptions during the same time. 

The Food and Drug Administration (FDA) warned parents and caregivers to keep benzonatate ‘out of reach of children to avoid unintentional ingestions in younger children and potential misuse and use for suicide attempts by older children.’

The drug is a popular alternative to narcotic cough medicines such as codeine. It’s also highly effective in treating a persistent dry cough. Between 3.5 million and 6.5 million prescriptions are doled out each year.   

The findings came in a study by FDA researchers which was published in the journal Pediatrics. 

Tessalon is a FDA-approved cough suppressant that is meant to treat severe cough in people over 10 years old.

It works within 20 minutes to relieve dry coughing by numbing the receptors in your airways that cause you to cough. 

Inappropriately taking the cough medicine can have severe health consequences. It is a prescription-strength medication and should be reserved for people dealing with respiratory infection and inflammation, allergies, and bronchitis.

But the drug could cause a host of side effects ranging from common and mild to severe. Adverse effects include bearable symptoms such as drowsiness, dizziness, headache, and stuffy nose.

The more dangerous side effects include a sensation of choking, numbness or tingling in your mouth, throat, face, or chest, and feelings of burning in the eyes.

The drug has not been tested for safety in children younger than 10, and fatal pediatric poisonings have resulted in a handful of cases.  

Prescriptions of the medication have jumped over the past decade despite the side effects, which many health professionals believe are preferred over the risk of prescribing narcotics to treat cough. 

‘The proportion of cases with serious adverse effects was low. There were few cases annually of serious [adverse events] with benzonatate in children,’ the report said.

Researchers added: ‘Rational prescribing and improved provider and caregiver awareness of benzonatate toxic effects may reduce risks associated with benzonatate exposure.’ 

While accidental ingestion was the most common reason for the poisonings, intentional abuse was most commonly reported among 10 to 16-year-olds.

The increase in capsules being doled out follows years of FDA advice against prescribing narcotics for cough for children 12 and under.

And with the drug becoming more commonplace, more reports to poison centers are to be expected.

The medicine is a good alternative to addictive opioids, thus it is becoming more and more common in people’s medicine cabinets.

Tuesday’s warning is not the first to come from the FDA about the misuse of the drug. 

Its candy-like led the agency to issue a similar warning in 2010 about a handful of fatal poisonings in young children involving Tessalon, which ‘may attract younger children because of the drug’s candy-like appearance.’