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Child Deaths Prompt FDA Warning on Cough Drug
http://abcnews.go.com/Health/Drugs/child-deaths-prompt-fda-warning-cough-drug-tessalon/story?id=12395444&page=2
12/14/10
After reviewing reports on 31 overdoses of the prescription cough medication benzonatate (Tessalon) -- including the deaths of five toddlers -- the FDA said it was beefing up the drug's label warnings and urging parents to keep it out of reach of children.
More Video
Watch: GMA Health (08.10.10)
Watch: Medical Warnings May Have Side Effects
Watch: Teens and Prescription Drug AbuseThe product is sold in colored gelcaps with a "candy-like" appearance, the agency indicated in a press release.
"Benzonatate should be kept in a child-resistant container and stored out of reach of children," said Carol Holquist, director of the agency's Division of Medication Error Prevention and Analysis. "The FDA encourages healthcare professionals to talk with their patients and those caring for children about the risk of accidental ingestion or overdose."
Read this story on www.medpagetoday.com.
The product will remain on the market, but new label information will be added about risks of accidental ingestion resulting in overdose and death in children younger than 10.
Benzonatate was approved in 1958 for treatment of coughs in patients 10 and older. It is available in 100- and 200-mg dosage forms.
An FDA review of adverse event reports disclosed 31 cases of overdose in children and adults, ranging in age from 1 to 66. The overdoses involved as many as 30 gelcaps and as few as one.
Most of these appeared deliberate. However, seven were ruled accidental, all of which occurred in children younger than 10.
Five of these -- all involving children younger than two -- ended in death.
Cardiac arrest, coma, and convulsions were common in the overdose cases.
Overdose Had Sudden Consequences
In six cases where the event report included information on time course of events, the FDA said, symptoms developed within an hour of ingestion, much faster in some cases.
The agency recommended that healthcare professionals prescribe the minimum number of capsules needed to treat an episode.
Providers should also advise parents to keep the capsules in childproof containers out of reach of children, the FDA said.
12/14/10
After reviewing reports on 31 overdoses of the prescription cough medication benzonatate (Tessalon) -- including the deaths of five toddlers -- the FDA said it was beefing up the drug's label warnings and urging parents to keep it out of reach of children.
More Video
Watch: GMA Health (08.10.10)
Watch: Medical Warnings May Have Side Effects
Watch: Teens and Prescription Drug AbuseThe product is sold in colored gelcaps with a "candy-like" appearance, the agency indicated in a press release.
"Benzonatate should be kept in a child-resistant container and stored out of reach of children," said Carol Holquist, director of the agency's Division of Medication Error Prevention and Analysis. "The FDA encourages healthcare professionals to talk with their patients and those caring for children about the risk of accidental ingestion or overdose."
Read this story on www.medpagetoday.com.
The product will remain on the market, but new label information will be added about risks of accidental ingestion resulting in overdose and death in children younger than 10.
Benzonatate was approved in 1958 for treatment of coughs in patients 10 and older. It is available in 100- and 200-mg dosage forms.
An FDA review of adverse event reports disclosed 31 cases of overdose in children and adults, ranging in age from 1 to 66. The overdoses involved as many as 30 gelcaps and as few as one.
Most of these appeared deliberate. However, seven were ruled accidental, all of which occurred in children younger than 10.
Five of these -- all involving children younger than two -- ended in death.
Cardiac arrest, coma, and convulsions were common in the overdose cases.
Overdose Had Sudden Consequences
In six cases where the event report included information on time course of events, the FDA said, symptoms developed within an hour of ingestion, much faster in some cases.
The agency recommended that healthcare professionals prescribe the minimum number of capsules needed to treat an episode.
Providers should also advise parents to keep the capsules in childproof containers out of reach of children, the FDA said.
That does seem odd to give a gell cap to such a young child. I do think parents need to be more responsible. If there's nothing on the label about dosages, then they need to call their doctor. You never guess! It's just common sense.
I even google stuff to check on it before taking many times. Yes, I've given my children cough medicine and I read the labels and put the medicine up. Parents do need to be more responsible.
I worry that people (parents) are being dumbed down and treated as if we can't be trusted. That only makes things worse.
I also worry that because of a few careless parents, they will ban cough medicine and most medicines for children. But then what? Ban adult medicine because the child might find it? Yes,we need to be more careful about keeping stuff up.
And Specialmom, I too, downed a bottle of cough medicine one time when I was around 4 maybe? My mom had put me down for a nap and had left the bottle on the dresser. Fortunately, I was fine. It must not have been the whole bottle. I didn't have to go to the hospital.
I left Tums out once and had my little one eat about 4 of them before I caught it. I called the poison control center and they said the child would have to eat several Tums before they would even get a tummy ache. But I still felt terrible about that and was more conscientious after that. We just have to be careful.
I even google stuff to check on it before taking many times. Yes, I've given my children cough medicine and I read the labels and put the medicine up. Parents do need to be more responsible.
I worry that people (parents) are being dumbed down and treated as if we can't be trusted. That only makes things worse.
I also worry that because of a few careless parents, they will ban cough medicine and most medicines for children. But then what? Ban adult medicine because the child might find it? Yes,we need to be more careful about keeping stuff up.
And Specialmom, I too, downed a bottle of cough medicine one time when I was around 4 maybe? My mom had put me down for a nap and had left the bottle on the dresser. Fortunately, I was fine. It must not have been the whole bottle. I didn't have to go to the hospital.
I left Tums out once and had my little one eat about 4 of them before I caught it. I called the poison control center and they said the child would have to eat several Tums before they would even get a tummy ache. But I still felt terrible about that and was more conscientious after that. We just have to be careful.
Hm. Well, it did say that many of the cases of overdose were intentional. And as to the kids, I'm confused. This was not an over the counter medication but a perscription strength cough suspressant, right? So a doctor perscribed it. And it is a gel tab, right? So that would make me wonder what child under the age of 6 would be perscribed such a medication.
If a doctor perscribed this medication for a child, it would be a problem. They probably perscribed it for the adult in the house and either the parent lost it when their child was sick and tried to dose it for them (which would be crazy to do) or the child got ahold of them and took them theirselves.
And while I agree that there are a lot of poopy parents out there---------- kids are quick and can do grave harm to themselves in mere seconds. If something can be lethal to a child-------- why wouldn't it be dispensed in a child proof container which this article indicates it might not have been?
And I had a super dee duper mom. But at 2 I downed a whole bottle of children's orange flavor aspirin. Yum yum. It was an ambulence trip and tubes up my nose and down to my stomach to pump it. Good times. Gosh, I hope no one was hard on my Mama or looked at her like she had done something wrong. Little bitty specialmom didn't feel good and in a split second got up on a stool in the bathroom, got those pills and took them all. I was suppose to be napping.
I do think if someone is trying to not deal with their crying, sick child and gives them a titch more med so they will sleep a bit . . . and you know it happens-------- they should be held responsible. And really, who would try and give a gel cap to a toddler?
If a doctor perscribed this medication for a child, it would be a problem. They probably perscribed it for the adult in the house and either the parent lost it when their child was sick and tried to dose it for them (which would be crazy to do) or the child got ahold of them and took them theirselves.
And while I agree that there are a lot of poopy parents out there---------- kids are quick and can do grave harm to themselves in mere seconds. If something can be lethal to a child-------- why wouldn't it be dispensed in a child proof container which this article indicates it might not have been?
And I had a super dee duper mom. But at 2 I downed a whole bottle of children's orange flavor aspirin. Yum yum. It was an ambulence trip and tubes up my nose and down to my stomach to pump it. Good times. Gosh, I hope no one was hard on my Mama or looked at her like she had done something wrong. Little bitty specialmom didn't feel good and in a split second got up on a stool in the bathroom, got those pills and took them all. I was suppose to be napping.
I do think if someone is trying to not deal with their crying, sick child and gives them a titch more med so they will sleep a bit . . . and you know it happens-------- they should be held responsible. And really, who would try and give a gel cap to a toddler?
When my kids were small and they did somethin to damage someone elses property, or if they hit someone and knocked a tooth out or the child had to be seen by a doctor, guess who was sued? Me. If they damaged a mailbox or threw a stone at a car and left a mark, guess who was responsible? You got it! Me! So why and how are things so different now I ask? And if the kid was out late at night without a parent, guess who brought the buggers home? The police and left a warning about it happening again. If my kid did not go to school, guess who showed up at the door? Parents used to be responsible for their children and it used to be if a kid got hold of medicine without the parents knowledge, the parent was looked at with "What kind of parent are you and maybe you should not be a parent"
This type of "parenting" is seriously laughable. With so many parents leaving all of the parenting to day care's and nannies, when left alone with their own kids - they haven't a clue as to what to do.....
Unfortunately this type of parenting (or lack there of) is prevalent in our little community. And from the looks of the community, you'd really think otherwise. It is a pretty affluent community filled with plenty of the nations millionaires.... and oddly enough, its some of these more affluent "parents" that are guilty of this.
I don't know. I give.....
Unfortunately this type of parenting (or lack there of) is prevalent in our little community. And from the looks of the community, you'd really think otherwise. It is a pretty affluent community filled with plenty of the nations millionaires.... and oddly enough, its some of these more affluent "parents" that are guilty of this.
I don't know. I give.....
Hold parents accountable for their actions AND hold them accountable for actions that result in harm to their children? The hell you say!!!
The government & lawmakers are responsible for our children and their care. How dare you infer that I should be held personally accountable for my actions, especially if those actions result in the harm of my child or my child'd death.
It's not MY fault the warning label didn't specifically state that I shouldn't give my child (30) capsules, and that said dose could result in overdose leading possibly to death.
Sheesh... you people. Expecting me to actually PARENT my children. What on earth is this country coming to.
The government & lawmakers are responsible for our children and their care. How dare you infer that I should be held personally accountable for my actions, especially if those actions result in the harm of my child or my child'd death.
It's not MY fault the warning label didn't specifically state that I shouldn't give my child (30) capsules, and that said dose could result in overdose leading possibly to death.
Sheesh... you people. Expecting me to actually PARENT my children. What on earth is this country coming to.
I was afraid to give my kids my doctors reccommended dosage of childrens tylenol or childrens advil..... The parents do need to be held to some accountability.
Why or why are the parents not held accountable for not reading and following the labels? What in gods name is going on in our society!
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