Tessalon (Benzonastate), a cough medicine for use in people older than 10 years, poses a risk to younger children because the capsules look like candy.
The United States Food and Drug Administration has recorded adverse events for the drug between 1982 and May 2010 and found seven cases of accidental ingestion of the medicine in children under 10. Five of these cases resulted in the death of the children, who were all aged two years or less. The medicine has never been tested for safety in children under 10 and for children less than two years, even one capsule can result in overdose.
Common adverse events reported in the overdose cases included cardiac arrest, coma, and convulsion. Signs and symptoms of overdose can occur within 15-20 minutes of ingestion. Some of the deaths reported in children have been within hours of the accidental ingestion.
The FDA is adding a new warning label to the cough medicine about accidental overdose.
“Benzonatate should be kept in a child-resistant container and stored out of reach of children," said Carol Holquist, R.Ph., director of FDA’s Division of Medication Error Prevention and Analysis. “The FDA encourages health care professionals to talk with their patients and those caring for children about the risk of accidental ingestion or overdose.”
Medicines are drugs and can be as dangerous as illegal drugs. Just because they are prescribed by doctors does not make them safe.
In addition to parental responsibility to keep drugs out of the reach of children, manufacturers also have a responsibility to design their products so that they don’t look like sweets.
If you are aware of a medicinal product that looks like confectionery, consider writing to the company to complain. It may save a child’s life.
If you or a family member has had an adverse reaction to Benzonatate, you can report it online at:
www.fda.gov/MedWatch or by calling 800-332-1088.