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:
Four months ago I wrote the last Lyme Journal Entry. I thought my strength would allow me to blog through the illness. Then the 5-6 month point turned my life upside down and it’s been hell. I fired my Lyme doctor and not taking meds at this time. I know many are wondering why the hair photo? I was losing hair by the handful and showering was nearly impossible with longer hair. When you can’t stand, lift your arms or sit down without falling, showering is a problem. I planned a nice Army shave but David would not help. I grabbed the scissors and cut eight inches off. Feels great, looks like crap. Who cares?
I’m sure people have noticed my positive attitude is quickly sliding. The mounting problems are not all Lyme-related. My cat Truffles is dying, lack of communication from my doctor, getting so sick, and walking some days is extremely painful. Our bed was too hard so I moved to a couch months ago. I live on the couch now. Not bad for sleeping except all the animals want to go out, poke me in the back, and the cat wants to attack me. Even attempting to get enough sleep is impossible. With Chronic Lyme Disease sleep is your best friend and a key to survival.
Let me share some Lyme politics for newbies.
Most of the expert Lyme Literate Doctors, are not practicing. Several years ago doctors were watching people die using CDC standards, which state patients can only receive 2-4 weeks of antibiotics at most. The Lyme doctors who understood how the viruses worked knew 4 weeks was a joke. The doctors worked together helping each out calling in antibiotics for the other patients. I have Chronic Lyme, and it can take 1-3 years to get well. Medication is one of the many ways to heal. Getting enough sleep is number one after the meds., take supplements, gluten-free diet and eat foods to help your body heal. No Coffee and drink only electrolyte water.
There was a huge division among Lyme doctors when the CDC allowed several doctors to patent the virus. Makes no sense to me. For years patients were clueless of the division. Both sides fought hard with the CDC to prove their data, from the videos on YouTube it looks like the battle was lost before the presentations started. The expert Lyme Literate doctors were quite vocal and a witch hunt is what followed the meeting. Doctors appeared before the Medical Board and were not able to practice, some for up to a year. Several doctors lost their clinic and everything they owned trying to keep their patients alive. It is a complete mess the CDC let happen, needless to say, I’m pissed. Just a little more background info to burn into your brain.
Many Chronic Lyme patients become so sick they are not able to work. The first reality is you no longer have insurance and can not afford new insurance if you could buy. I’ve watched video after video on YouTube of people with good-paying jobs, racking up several thousand dollars in doctor bills and many having to file bankruptcy, losing everything. One video told of a couple who owed their parents $500,000. Lyme affects everyone in your family, friends, your health, and financial security.
It’s going on Spring in some parts but summer will be here quickly. I don’t want any of you or your family members to struggle with a virus that looks like a worm. The viruses travel through the blood until they can find a way to your major organs. Lyme likes to get cozy in the liver, kidney, heart, and brain. I have three tick-borne illnesses and Epstein Bar Virus. I have cognitive issues, my eyes constantly see things moving by my peripheral vision and balance are fleeting. I was in the bathroom two days ago about to reach for the medicine cabinet. I slammed into a wall hurting my writs and several fingers. If that wasn’t enough I slid down the wall falling on the toilet and hurt my leg. The doctors don’t know how much of your ability will come back if any. You have to keep fighting.
Why I fired my doctor. My husband and I formed an impression at the first appointment, not so good. I was desperate to start treatment and had no other options.
* I start a couple of drugs until the Lab work is back. At the follow-up appointment, the first words out of his mouth are you are in a great deal of pain. REALLY? His communication and organization skills are lacking. No pain meds were prescribed. He has to call someone in to bring him something several times during the appointment.
*I’m loaded down with over 50 pills to take a day plus 15-20 supplements and sleep all I can. The equation doesn’t work. I have gastro issues and the high-powered antibiotics made me nauseous all the time. I asked to have a PICC line in my arm to give my stomach a break. He did not plan to use a PICC line? Almost every patient gets a PICC line so they can fill you full of drugs and bypass your stomach. My wheels are turning. He had lab work for me to do, but I didn’t do it. He never asked about the Labs. He said my Lead levels were three times higher than normal, in the dangerous range. No follow-up test was ordered, it was like “So you know”. I’m scared, my brain is on overload, the test said current and ongoing exposure. I spent about two weeks looking for an answer. I looked at the top of the report one day, it wasn’t my report. Admin acted like no big deal. HIPPA laws are not new.
With the list of experts I start going down the list, ONE of the leading Lyme Literate Doctors still practices. The doctors called before the Medical Board and CDC. Now are full-time advocates/researchers. I phoned his office in DC and they are taking patients. When you have cognitive issues filling out 50 pages is crazy. I stayed up last night to get everything I could without waking my household. With God’s help, I will finish the paperwork tomorrow and get an appointment in the next month.
ILADS is the professional organization Lyme Literate doctors belong to. I saw the tab on site for ILADS Protocol on Lyme. I jumped for joy. Let’s hit them with our best shot. We have boxing gloves on and the truth will come out. The document was extensive for the different stages of Lyme or other tick-borne illnesses. I felt so happy that others may not have to suffer shortly. The document was well-researched by leading scientists, leading hospitals, and large populations of people. I cheered when I read research that outlined how the current system is incorrect, and they went all out. On the issues of insurance, extensive research with real patients exposed what the CDC is keeping from the public. If you want to learn more about Lyme, YouTube has so many videos, you might not have to go anywhere else. If you like the medical jargon go to the ILADS site.
A shout out to others who suffer from Lyme or tick-borne illness. I think of you, pray for you, and send good karma your way.
It’s interesting the events our mind suppresses or forgets. I have no problem or emotion talking about the physical and emotional abuse at the hands of my mother and step father. I have disassociated memories of sexual abuse by my father. I know it. My therapist and I have talked about it, she doesn’t push and knows if the door opens I’ll talk. What I will not do is force my mind and body to endure pain it’s not ready for. I have a good perspective on what I’ve survived and the methods our mind uses to deal with our deepest pain. I’m not sure if this particular memory was forgotten or suppressed. I had no emotion as my therapist was almost brought to tears.
I saw a story on the news about a 8-year-old girl tortured by her parents in some way. I don’t recall the circumstances. I always plan what I want to talk about but this day was different. I sat down and the memory of the little girl crossed my mind. I asked her if she had heard the story then adding my thoughts. I started to cry which I do easily for others in pain. As we talked about what type of parent would do that, a childhood memory flooded over me. The tears dried and it was if I was talking about someone else. When I was 8 years old I started having terrible side pains and daycare called my mother. She didn’t take off early and it was maybe 3 hours before she arrived. At that point I could barely walk and could not walk and breath. The supervisor thought I had an appendicitis attack and should get to the hospital right away. It was Halloween night and I didn’t want to miss out on the candy but pain was taking over my small body. My mother was angry for ruining things for my brother, nothing new about that. I guess we did not have insurance since the first hospital turned us away. We are talking early 1970’s. She drove to the county hospital and I waited on a bed until the people bleeding and dying received treatment. Halloween night is one of the busiest nights of the year with more shootings than normal. The emergency room was full and I was outside a mans curtain to wait my turn. During this time my mother left to take my brother to trick or treat. I didn’t realize until a nurse asked where she was. I said she talked to a nurse and went home. She was a big woman and I knew nobody gave her any shit. Asking why in the hell my mother would leave me there. My answer did not sit well with her, I knew a beating was in store for me. One thing to keep in mind is the county hospital is in the hood in one of the worst areas of Dallas. This is not a place an adult would feel comfortable let alone a child. I was on my side crying in pain and saw the man thru the curtain. He was an older man and he had what looked like wires coming out of several places on both arms. My eyes caught his, I ask does that hurt. He was a kind man saying not as bad as my pain did and then where was my mother. I told him how upset I was that my brother would not share his candy with me. He looked shocked my mother would leave me there. My mother eventually came back in the greatest of moods and was raising her voice at the big nurse. I was rooting for her to punch my mother if the mouth or grab her by the neck. I have no doubt it happened many times getting drunks under control.
The doctor didn’t think I needed surgery, just to stay overnight for observation. For a second I was glad until rolled to my room. The hospital was so overcrowded I hade to sleep in a baby bed. That is the last thing a kid (big girl) wants to hear. I cram myself in the bed and they pull the side up. It was so dark in there I thought I was alone until babies started crying. Which made it much worse for me. Not only did I have to sleep with my legs pulled up, babies are crying and my mother is home in her comfortable bed.
You would think at this point in the story I would feel some emotion but my mind switches back to the little girl. My mind turned a switch, my story was over, no big deal, that was my mother, that was my life. I couldn’t help but cry for the other girl. How can people do that to their children. As I’m talking to my therapist my story and pain never crosses my mind again. That was several years ago, it buried itself and popped back up last week.
Being diaognosed with Chronic Lyme Disorder in 2014/2015 changed my life and my husbands forever. After 18 months of IV Antibiotic Treatments, I survived, and in remission at this time. Since the spirokettes remain in your body, your body can continue to decline whether in remission or not.
Over a 12 months of testing, my Neurologist has performed every test in her arsenal except a spinal. Every test she ran came back abnormal yet not able to pin down a diagnosis. She refered me to a Rheumatologist to start on the tread mill again. I started researching illnesses which included brain wave abnormalities to weed out my more common symptoms. There were the ones I expected, Lupus, Multiple Sclerosis or other autoimmune disorder. I didn’t think the answer would come from the crazy searches by using the abnormal test results and symptoms in every combination possible, I thought I had the answer and I did.
More reasearch and what I found was alarming, not the illness alone, the politics and witch hunt taking place. The illness is Lyme or other tick borne illnesses. The CDC rates Texas as med-high concentration. The east coast is at epidemic levels with some articles stating we are facing epidemic levels across the country. I had a different idea for this post yet feel it’s critical to get this information out ASAP. When I learned of the divide in the medical community over Lyme, I shook my head. What is the controversy? The CDC establishes treatment standards for doctors and the standard Lyme test is based on 30-year-old information. What happens is you go to doctor for a Lyme test, it comes back negative. You then find out the test is 30% +/- correct. The CDC acknowledges the test has false positives yet the standard for testing hasn’t changed.
With a lack of confidence in the test, I wanted to see a Lyme Literate Doctor. This blew my mind, a current day Salem Witch Hunt is happening. On one side of the controversy are doctors who specialize in Lyme and tick borne illness. If a tick bite is not caught right away it grows in your system. Lyme looks like a long skinny curly worm. It bores thru your body damaging your organs or brain depending where it lands. The symptoms can move around your body as the virus spreads. Lyme is hard to kill, it can encapsulate itself in an invisible cocoon and is near impossible to see under microscope. The Lyme doctors take the approach, attack the virus aggressively for long periods of time to prevent a relapse. People who are very ill from Lyme can require years of antibiotics. Not only to kill the virus more importantly to save your life. Heres the rub, the CDC states 2 weeks of antibiotics will cure Lyme and doctors can prescribe an extra 2 weeks if needed.
Medical insurance companies only pay what the CDC approves and the CDC doen’t recognized Chronic Lyme Dieases nor in IV treatments. Some Lyme doctors are getting called before the Medical Review Board having their license taken away for a year. Insurance companies are cancelling people’s policy and they are left with 150k+ in out-of-pocket expenses. There are many patients who have to lose their house or get their loved one treatment.
There are two main thoughst on Lyme Dieases, doctors that do not believe in Chronic Lyme Dieases and the others that do and are treating patients. The CDC hasn’t changed their rules on insuring Lyme treatments but I don’t think doctors are not under as big of a microscope.
When I decided to see a Lyme Literate doctor it was a process. I called the association, they took info on where I lived and would call back. The next morning I received a call with a doctor’s name and phone number. I later found out the doctor I’m seeing was the first to lose his licenses for a year. I didn’t know if I should jump for joy or not.
I’m battling over 50 symptoms on any given day from a tick that is smaller than a sesame seed. When you’re doing tick checks on you and the kids, ticks are hard to see. Around 30% to 50% of people get a bull’s-eye rash. If you get the rash go to the doctor right away and ask for a Lyme panel test.
Please remember to check your scalp, they can hang out in your hair. A flashlight might help with this task. I’ll keep you up to date on how my appointment goes. I’m not worried about what, I need an answer to move on to the next hurdle. I will do a f/u post including more information about treatments.
lookingforthelight.blog 