Tessalon Pearls Warning

From: http://www.examiner.com/family-issues-in-national/fda-press-release-tessalon-pearls-cough-medicine-deadly-for-children?render=print#print

Tessalon (Pearls) cough medication deadly for children
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FDA PRESS RELEASE: Tessalon (Pearls) cough medicine deadly for children

By Patricia Walston, Family Issues Examiner
The FDA has released the following information to warn parents of the dangers of a cough medication that can be deadly for children under 10 years of age.
They have not been studied/tested in children under ten years of age and deaths have occurred with only a few ingested.
They have a candy like appearance and are enticing to children. They must be kept in a child proof container and far away from the reach of children. Do not be tempted to give your child under this age one of these in an effort to relieve their cough. Never give a child a medication prescribed for an adult.
It is a good idea to never let children see where you keep them; and do not let them see you taking medications – Monkey see – Monkey do.
If you have any questions about this you can call 1-888-INFO-FDA
Again, the warning is that Tessalon (benzonatate) ingested by young children under ten years of age can be deadly.
Even those who are prescribed this medication should not take any more than what is prescribed. And with the onset of side effects, they should contact their pharmacist or family doctor.
Physicians are encouraged to warn their patients about the dangers of this medication around young children.
There have been seven cases of accidental overdose in children younger than ten and five of those children died. The smaller the child the less it would take to cause a serious result.
The FDA warns:
“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.”
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Also those with heart problems such as rapid heart rate should also discuss this at length with their medical caregiver as it could cause complications there as well in older people.
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.

Consumers and health care professionals are encouraged to report adverse side effects or medication errors from the use of benzonatate to the FDA's MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling 800-332-1088.
http://www.fda.gov/Drugs/DrugSafety/ucm236651.htm
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