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Subscribe to RSSCodeine can kill some children when it is used to help with pain after tonsil and adenoid surgery, and it shouldn’t be used any more, the Food and Drug Administration cautioned on Wednesday.
The FDA said it was adding a strong warning, called a boxed warning, to the label of the drug, and also will warn that it is not to be used in certain patients – especially children after tonsil or adenoid surgery.
“Health care professionals should prescribe an alternate analgesic for post-operative pain control in children who are undergoing tonsillectomy and/or adenoidectomy. Codeine should not be used for pain in children following these procedures,” the FDA says in a statement.
Last year, the FDA said it was investigating the deaths of three children. They died after getting their tonsils or adenoids removed, and had been given codeine to ease the pain. Codeine is turned into morphine in the liver, and morphine can suppress breathing.
“Many of the cases of serious adverse events or death occurred in children with obstructive sleep apnea who received codeine after a tonsillectomy and/or adenoidectomy,” the FDA said.
The children appeared to have metabolisms that natually converted codeine to morphine at an unusually high rate – meaning they got a higher-than-expected dose of the drug once the body processed it.
“Since these children already had underlying breathing problems, they may have been particularly sensitive to the breathing difficulties that can result when codeine is converted in the body to high levels of morphine. However, this contraindication applies to all children undergoing tonsillectomy and/or adenoidectomy because it is not easy to determine which children might be ultra-rapid metabolizers of codeine," the FDA says.
The FDA says between one and seven percent of people are “ultra-rapid metabolizers,” but people of North African, Ethiopian, Greek and African-American descent are especially likely to be.
The FDA says parents should call 911 if their children have been given codeine and show any of these signs:
- Unusual sleepiness, such as being difficult to wake up
- Disorientation or confusion
- Labored or noisy breathing, such as breathing shallowly with a “sighing” pattern of breathing or deep breaths separated by abnormally long pauses
- Blueness on the lips or around the mouth
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- Common pain meds don't always work, study finds
- Ibuprofen works best for kids' pain - study
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When my son was 9 he had his tonsils out and slipped into a coma for 3 days. The doctors had no answers for it then in 1993, this now makes sense.
Ahh man!!! But he was ok after that right?!
"The children appeared to have metabolisms that naturally converted codeine to morphine at an unusually high rate – meaning they got a higher-than-expected dose of the drug once the body processed it."
I have never been able to take Codeine after any surgeries. My doctors always told me that I was wrong that it could not have that type of effect on me. I am the same way with other sleep aids. My body doesn't like them and I have a really hard time waking up. Its nice to know that my doctors didn't have a clue about what they were talking about.
FDA approves the sale of cigarettes to white trash - smoking must be healthy!
FDA has no jurisdiction over cigarettes. Learn the law before you comment on it.
Thank you for this information!! My 2 kids (8&9) are just about to see the tonsil and or adenoid specialist, so I now know to use codeine!!! Man was this a coincidence or just good timing?!?!?!?! Thanks again!!!
Good grief, who could think that treating a small child with codeine could be a good idea? At the very least, codeine can cause excruciating constipation, but as the article indicates, liver failure and/or death are even bigger downers..
Back in the day, "routine" tonsillectomies and adenoid removal were done on just about any tyke over five who suffered a sore throat. Post-op pain was treated with all the orange sherbet the patient could eat. The "routine surgery" was ultimately deemed a very bad idea given that without the tonsils as a "germ catcher" sore throats could easily develop into strep infections. The orange sherbet was yummy and soothing, but I was plagued with strep throat for years. Cure worse than the original disease.
this is extraordinarily rare, and can be easily remedied by taking stool softners or laxatives either prophylactically or at the onset of symptoms (before becoming excruciating)
id be surprised if you could find 50 cases of this EVER in healthy patients without prior liver disease who took the drug as directed
I'm an ultra rapid metabolizer. I can see how it would be a problem. I'm allergic to aspirin and aspirin derivatives that causes a specific type of rather rare seizure. That eliminates almost everything OTC, except acetaminophen. Got a dental problem a few years ago and I wound up taking 39,000 mg in less than a week before I could get some help. The dentist looked at me like, how are you standing ? So something like vicodin you get a tolerance level real quick. I can see how that would be a huge problem for a child who is still growing.
Antibiotics tend to work faster though.......everything has it's pro's and con's depending on the circumstances. I got acetaminophen related asthma if I took more than three for a while after that. Pain management is a tricky thing and should be customized for each person. Surely there's a test that could be developed in the presurgical work-up to detect people who are ultra rapid metabolizers.
Both my mom and sister were/are more rapid metabolizers. I therefore refuse codeine. I had my wisdom teeth out-all four, all of which were impacted-this summer. Guess what? I did JUST fine on extra-strength advil and ice. Didn't even take the steroids they wanted me to. I DID take the antibiotics, which I didn't want to, as a preventative because of a heart valve defect.
I actually have two points.
One, they're still doing too many tonsillectomies/adenoectomies. Two...just use non-prescription medications and TLC. Please. We are in way too drug-dependent a society.
Five years to late for my brother Paul who died from this. The hell my family has gone through.
My son just had his tonsils out about a month ago. They stated that he was in extreme pain after surgury and gave him loratab which is acetominophin and hydrocodone. It was a lifesaver. I gave it to him for 4 days (as needed) not everytime he was due for a dose. After the first day it was like 2 doses a day and in between the advil/tylenol (not given back to back with the loratab). He ate doritos 2 days after surgury. Yes these kids in distress need a little bit more. Why not give it to the kids not at risk for being fast metabolizers and give them an alternative treatment. The doctor said that the problem is that some of the parents knew that the drug had street value and he had a hard time prescribing it. The kid cried a bit and it was hard to let him cry it out but you did until it was time for his next advil/dose. He was back to school a week after surgury. Kids over 12 and adults have a harder time. This study was based on 3 patients. Kids do not get the pain meds they often need and suffer needlesly. They have gotten rid of tylenol and other cold medicine because parents get desperate and give it and give it to the point it builds and causes problems. It is not the medicine to blame, but rather stupid people in many cases.
Now they tell us! I know I had codeine for a number of procedures when I was a young child, and this seems to shed some light on some problems I still have today.