Kids potentially confuse cough medicine with candy
by Aimee Keenan-Greene
It may look like candy, but its really a liquid cough medicine that should be kept in child-proof containers.
That's the warning about Tessalon that came from the Food and Drug Administration today.
The FDA says Tessalon poses a risk to kids under 10 who may accidentally ingest it.
Tessalon benzonatate is approved by the FDA to treat symptomatic relief of cough in patients older than 10. Children may be drawn to the medication because of the round, liquid-filled gelatin capsule - but it can cause serious side effects including cardiac arrest, coma, and convulsion.
Signs and symptoms of overdose can occur within 15-20 minutes of ingestion. In some cases deaths have been reported within hours of the accidental ingestion.
A review of the FDA’s Adverse Event Reporting System database from 1982 through May 2010 identified seven cases of accidental ingestion associated with benzonatate in children younger than 10. Five children under age 2 died. Benzonatate overdose has been reported in kids this young who take just one or two capsules.
“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.”
The FDA is also adding a new Warning and Precaution section to the benzonatate drug label to warn health care professionals about accidental ingestion resulting in overdose and death in children younger than 10.
Children under the age of 5 are the majority of the 100,000 Americans treated annually in emergency rooms after accidentally swallowing medications.
Most occur in 1 and 2 year olds, according to a new report from the Substance Abuse and Mental Health Services Administration. 85 percent of children were treated and released from the ER.
About 10 percent had more serious injuries and required hospital admission.
About 90 percent of child poisonings happen in the home, according to the Consumer Product Safety Commission. Child poisoning deaths have fallen by 80% since 1972 because of better packaging. However, than 30 children a year still die from poisoning.
Keep kids safer this holiday season by keeping an eye on your pill bottles. The CPSC suggests taking some simple measures before your guests arrive, or when you visit a friend or relatives home:
Properly dispose of unneeded or expired medications
Don't take medications in front of children, which may inspire them to try to imitate you.
Never refer to pills as candy.
Because children can sometimes open child-resistant caps, keep medications out of sight, out of reach and in a locked container.
The Poison Control center number is 800-222-1222.
To report adverse side effects or medication errors from the use of benzonatate, contact the FDA's MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or call 800-332-1088.



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