Editor's choiceMain category: Pediatrics and children's health
Also included in: pharmacy / pharmacist. Respiratory / asthma. Regulatory Affairs / Drug Approvals
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FDA warns that liquid capsules Tessalon (benzonatate) can have serious and sometimes fatal consequences for children under the age of 10 years who accidentally ingest. Drugs should be kept out of reach of children and child-proof containers.
Tessalon is hereby approved for the relief of the symptoms of cough in patients aged 10 years or more. The FDA (Food and Drug Administration) warns that younger children can be attracted by it because of its round gelatin capsule filled with liquid, giving him a candy appearance.
The safety and effectiveness for children less than 10 years only has not been established by the Tessalon agency adds.
Carol Holquist, R.Ph., Director of the Division of prevention of medication errors and analysis, the FDA said: "Benzonatate should be kept in a child resistant container stored out of reach of children." The FDA encourages health professionals to care for children with their patients and those at risk of accidental ingestion or overdose. "Intake accidental among children aged ten years seven cases have been reported since 1982, depending on Adverse Event Reporting System database of the Agency. Five of them every year up to two years, has died. A child under the age of two must ingest one or two capsules benzonatate for risk of death to become a reality.
The following adverse effects have been reported form child overdose - cardiac arrest, convulsions and coma.
For 15 to 20 minutes to take the drug overdosed child will have the signs and symptoms. Some children died, did so within hours of accidentally taking the medication.
A new implementation and precautions section is added to the benzonatate drug label. The goal is to warn doctors and other professionals of the health hazards of accidental overdose and ingestion in younger children.
Health professionals and consumers are encouraged to report adverse events or benzonatate, use the FDA's MedWatch Adverse Event Reporting program-related medication errors.
Source: FDA
Written by Christian Nordqvist
Copyright: Medical News Today
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