FDA MedWatch – Codeine Cough-and-Cold Medicines in Children: Drug Safety Communication – FDA Evaluating Potential Risk of Serious Side Effects
07/01/2015

Codeine Cough-and-Cold Medicines in Children: Drug Safety Communication – FDA Evaluating Potential Risk of Serious Side Effects
AUDIENCE: Family Practice, Pediatrics, Surgery, Patient

ISSUE: FDA is investigating the safety of using codeine-containing medicines to treat coughs and colds in children under 18 years because of the potential for serious side effects, including slowed or difficult breathing.

Children, especially those who already have breathing problems, may be more susceptible to these serious side effects. In 2013, FDA warned against using codeine in children who recently had surgery to remove their tonsils and/or adenoids.

In April 2015, the European Medicines Agency (EMA) announced that codeine must not be used to treat cough and cold in children under 12 years, and that codeine is not recommended in children and adolescents between 12 and 18 years who have breathing problems, including those with asthma and other chronic breathing problems.

FDA will continue to evaluate this safety issue and will consider the EMA recommendations. Final conclusions and recommendations will be communicated when the FDA review is complete.

BACKGROUND: Codeine is a specific type of narcotic medicine called an opioid that is used to treat mild to moderate pain and also to reduce coughing. It is usually combined with other medications in prescription and over-the-counter (OTC) cough-and-cold medicines.

RECOMMENDATION: Parents and caregivers who notice any signs of slow or shallow breathing, difficult or noisy breathing, confusion, or unusual sleepiness in their child should stop giving their child codeine and seek medical attention immediately by taking their child to the emergency room or calling 911. Parents and caregivers should always read the product label to find out if a medicine contains codeine and talk with their child’s health care professional or a pharmacist if they have any questions or concerns. Health care professionals should continue to follow the recommendations in the drug labels and use caution when prescribing or recommending codeine-containing cough-and-cold medicines to children.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: http://www.fda.gov/MedWatch/report
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including links to the Drug Safety Communication and previous MedWatch alerts, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts

19 Comments on “FDA Investigate Serious Side Effects Of Codeine In Children's Cough And Cold Medicine

  1. Well, you just know I have to jump in here.
    1) Codeine is a drug derived from the poppy plant. It has been in use for well over 100 years, with no particular problems other than occasional stomach upset, and adverse effects if given during a SEVERE ACUTE asthma attack. Children with mild asthma who have increased cough due to a cold generally have no adverse effects if given codeine, and may show improvement due to suppression of “irritative cough,” which is what it sounds like: the airway gets irritated from lots of coughing, and this triggers the asthma, and becomes a vicious cycle. In select cases, judicious use of a cough suppressant can break the cough-wheeze cycle. Unfortunately, most of today’s physicians are trained by rote and not by bedside experience, so they just go by the book=no codeine.

    2) Codeine is an old, old drug, and it is not patentable, so it makes sense that Big Pharma lobbies would encourage scare stories, to further encourage physicians to prescribe THEIR “safe” products instead (read: “safe and expensive.”)

    3) Codeine is not a “one size fits all” drug in children. The dose MUST be calculated according to the child’s exact weight. Therefore, if the bottle says “children aged 6 to 12 1/2 teaspoonful,” and you have a 6 year old who weighs as much as the average 4 year old, you’re looking at a mild overdose with CNS symptoms such as lethargy, grogginess, and possible respiratory depression. On the other hand, if you have a chubby 12 year old, that dose is not likely to do anything at all, and that might lead to repeated dosing until the doses stack up and you get an overdose.

    4) Enter the recent demonization of any drug originating with the poppy plant (opioids). For crying out loud, the medicos prescribe all kinds of harmful drugs with dose-dependent side effects, and they are called “good” because they were made in a lab. True, many people get addicted to/overdose on opioids, but I think this is a multifactorial problem and not the fault of the drug. If there were different drugs that worked as well yet were non-addictive, I’m sure they would be accordingly well loved.

    In the 1920’s (during Prohibition) codeine became a very popular way to get high, and many people became addicted. The most popular form was cough syrup, which could be had without prescription. I’m not sure when, but The Powers That Be came up with the brilliant strategy of adding the nauseating chemical Terpenhydrate to the codeine, to make it unattractive to addicts. Enter heroin. Just like now, that physicians are refusing to provide opioids to people who suffer with pain, the number of people turning to heroin for relief is sharply on the rise.

    In summary, it’s my opinion that codeine is a very safe drug to use in children, as long as the prescriber uses common sense in considering weight-based prescribing and prudence in considering co-morbidities like severe asthma, heart disease, morbid obesity, and anything else that could be adversely affected. Parents also must exercise due diligence in reading the pharmacy label and not varying from instructions unless advised by the physician.

    Thus ends my treatise on use of codeine in Pediatrics.

    Liked by 1 person

    • I always value your opinion. I can’t take it, vomit everytime. One problem I see is parents aren’t as diligent reading label. The problem I’ve encountered lately is Patient Information from manufactures is no longer included. With all the additional drugs I’ve spent endless hours getting info on detail list of side effects at what dosage level. Several drugs I take can cause risk, I do my own research and share concerns with my Psychiatrist.
      When a FDA Update for my drugs comes out, I have to read and get details of what is driving investigations.
      As for drug addicts having to turn to heroine to get high. I can’t feel sorry or worry about connivence of getting a drug. I was a drug addict dating a dealer. The best thing that’s happened is kicking drugs and staying off for so long.
      I hope your travels are going well. Take care out on the road.
      πŸ™‚
      M

      Liked by 1 person

      • Ouch, I didn’t realize you are an addiction survivor. I’m so glad you have kicked and stayed kicked. I wish there was some way of relieving people’s pain that didn’t lead to potential disaster. I’m very worried about the heroin epidemic that’s going on currently, as a direct consequence of the pain meds squeeze. However, in Colorado the drug arrests are down some enormous percent since marijuana was legalized for general consumption. I’m wondering whether more people are relying on the pain mitigation effects of mj, and not feeling compelled to turn to opiates. What do you think?

        PS I also can’t stomach codeine. And even the smallest dose of any opiate makes me itch so bad I can’t stand it. I only take it post-op or if I’ve broken something….

        Liked by 1 person

      • I haven’t payed any attention honestly. I think Meth is a huge problem and very addictive. Because I don’t think about drugs an longer something really has to hit me to think about people with drug addictions. It’s not I don’t feel compassion. I seen enough to make me cry, how young girls get addicted to Meth and when they can’t afford they turn to selling their body. It’s heartbreaking to see how quickly this plays out on the streets of every town.
        I very sick and feel like death so I don’t keep up with much.
        I wish you well in your efforts to bring this to attention.
        πŸ™‚

        Like

      • Oops I think I might not have been clear…the people turning to heroin are actually not addicts, they are people with legitimately painful conditions like neuropathic pain, severe arthritis, spinal stenosis, and more, for whom opiates are the only thing that works, they are on stable doses, using a patch…these people are being denied their pain meds and are turning to the black market to get pain relief. And I’m sure that then they’re bound to get addicted to that evil drug….It’s a tragedy bred by fear and ignorance.

        Liked by 1 person

      • I have not heard of anyone being turned away from legit pain issues. I have terrible neuropathy, the Lyme doctor put me on several drugs to get around any addition issues. Of course I told her no codeine.We’ve spent how many years trying to control drugs, I don’t know the answer.
        πŸ™‚

        Liked by 1 person

      • Not to sound corny, but love is the answer. After being a homeless street kid, I scrambled my way to med school, and from there to a residency in pediatrics and adolescent medicine. Almost killed me, destroyed my family, my mental health of course…somehow I started working at a clinic for street kids like I had been…when the girls came in with abscesses, types of VD I had only seen in books, etc, they were shocked to know that yes, I DO know what it’s like…And it IS possible to get off the street, but very hard…And fortunately our clinic had the support services to get them clean and sober, get their GED, get job training, housing, child care…But of course the state did not find our cause worthy, and pulled our funding…The staff worked for free as long as we could, then the landlord kicked us out. I hope and pray that at least one of those kids made it. With love and money, all things are possible 😦

        Liked by 1 person

      • It wasn’t until my probation officer said the vote was to send me to boot camp style facility, I tried to be cool but was scared to death. My grandmother and probation officer got together and found a convent for troubled teens. I had to go cold turkey on drugs, that was very hard. I stayed a year at the convent. I share my story in post when it makes sense. I’ve been thru many struggles and like you I offer help to anyone who needs it.
        Life is hard, put other traumas on top of it gets real hard. I had help in my journey to wellness and developed a strong desire to change who I was. People have to really want to get out of bad situation and some luck.
        I was one who could see the roads and the choice saved my life.
        πŸ™‚

        Liked by 1 person

      • Whoa. I want to hear that story…Even thinking about a convent gives me the shakes. One reason I kept running was that I was terrified I’d get locked up somewhere. Ironic that I ended up locking my son up for a couple of years, but it was a very good place and he grew into himself there. He was mighty pissed at me at first, but he knew it was that or jail, so to therapeutic boarding school he went. I weep many tears over kids who needed that support but instead ended up in jail or dead, which is where he was headed. I might have been too, for all I know. Probably was. But since I learned how to disappear very early on, like age three, that turned out to be my survival strategy, and I must have lived through it because here I am writing this.

        Liked by 1 person

      • It was an adjustment at first but it didn’t take long. After years of abuse, any positive attention changed my outlook. There no doubt I was spiraling down. I was on probation for being caught with a gun at 12 yrs old. Looking back it was a blessing, a boot camp style would have hardened me and life would be different.
        Here’s a toast for both of us surviving.
        πŸ™‚
        M

        Liked by 1 person

      • Sometimes it helps to write and not post. See how you feel in a week, sometimes emotions get us in trouble. We both say what we think which not everyone can take.
        If you feel the need to say it now, then do it, it could make you feel better. That’s the goal.
        πŸ™‚
        M

        Liked by 1 person

      • **gulp** these are about things that happened a week ago, a month ago….I feel fortunate to have Bloggie friends like yourself who don’t judge me….And I get a lot of feedback from people who say reading what I write helps them in some way, so I feel like it really is a two-way street, I get to write about my life and experiences, and other people help me to process that…And if someone else feels helped in that process also, I can’t ask for much more (except to be healthy and working, but then I wouldn’t be writing about these things…)

        Liked by 1 person

      • We’re here for each other and for anyone else who reaches out. You have to go with your gut. If writing about now will take a load off your back, then you should write.
        πŸ™‚
        M

        Like

I want to hear your thoughts. I can take it!

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