Do not use codeine, tramadol in children: FDA

by Melissa Jenco · News Content Editor American Academy of Pediatrics News

Codeine and tramadol should not be used to treat pain or cough in children younger than 12 years as they could be fatal, the Food and Drug Administration (FDA) said Thursday.
The FDA unveiled several changes to the labels of the medications to protect children, adolescents and infants being breastfed.

“We are requiring these changes because we know that some children who received codeine or tramadol have experienced life-threatening respiratory depression and death because they metabolize (or break down) these medicines much faster than usual (called ultra-rapid metabolism), causing dangerously high levels of active drug in their bodies,” Douglas Throckmorton, M.D., deputy center director for regulatory programs in the FDA’s Center for Drug Evaluation and Research, said in a statement.

The FDA is adding the following new restrictions to the warning labels of codeine and tramadol:

  • Codeine is contraindicated to treat pain or cough, and tramadol is contraindicated for treating pain in children under 12.
  • Tramadol is contraindicated for treating pain after surgery to remove tonsils and/or adenoids for children under 18. Use of codeine for this purpose was placed under the same restriction in 2013.
  • Codeine and tramadol are not recommended for use in adolescents ages 12-18 who are obese or have conditions such as obstructive sleep apnea or severe lung disease.
  • Mothers should not breastfeed when taking codeine or tramadol.

Since 1969, codeine has been linked to 64 cases of serious breathing problems, including 24 deaths in children and adolescents. Tramadol is not approved for pediatric use but has been tied to nine cases of serious breathing problems, including three deaths in children and adolescents, according to the FDA. There also have been cases of breathing problems in breastfed infants whose mothers were taking codeine.

In September 2016, the Academy released a clinical report Codeine: Time to Say “No” that expressed concerns about the dangers of codeine use in children and called for more formal restrictions.
The FDA recommends physicians use other medications for treating cough and pain. Officials also encouraged parents to pay close attention to the ingredients in medication they give their children and seek immediate medical attention if children taking the restricted medications experience difficulty breathing, confusion, unusual sleepiness, trouble breastfeeding or limpness.

Resources

FDA Drug Safety Communication http://bit.ly/2or5PHZ
FDA Q&A on the use of codeine and tramadol in breastfeeding women, http://bit.ly/2pjylz2
Consumer Update: Codeine and Tramadol Can Cause Breathing Problems for Children, http://bit.ly/2pWK2b8
Healthychildren.org information for parents on the use of codeine, http://bit.ly/2ovoQrL

Hungry or Bored?

Children sometimes use food for reasons other than hunger to satisfy themselves.  These reasons may be in response to their emotions or feelings.  Many things can trigger hunger such as:

  • boredom
  • depression
  • stress
  • frustration
  • insecurity
  • loneliness
  • fatigue

One way to keep your child from eating out of boredom is to steer them towards activities that keep them busy.  Also make sure your child eats three well-balanced meals and one snack each day.

A few things to do instead of eating would be:

  • walk the dog
  • walk around the neighborhood
  • kicking a ball around
  • painting a picture
  • running through sprinklers

Dog Bite Prevention Week

May 15-22, 2016 is Dog Bite Prevention Week®.

Each year, more than 4.5 million people in the US are bitten by dogs. Of the 800,000 who seek medication attention, half are children.

Since most dog bites involve familiar animals, prevention starts at the home.

The American Pediatric Association gives the following tips on preventing dog bites:

  • Almost 1 in 5 people bitten by dogs require medical attention. For children, the injuries are more likely to be serious. Parents should be aware of some simple steps that can prevent dog bites.
  • Never leave a small child and a dog alone together, no matter if it is the family dog, a dog that is known to you, or a dog that you have been assured is well behaved. Any dog can bite.
  • Do not allow your child to play aggressive games with a dog, such as tug-of-war or wrestling, as this can lead to bites.
  • Teach your child to ask a dog owner for permission before petting any dog.
  • Let a dog sniff you or your child before petting, and stay away from the face or tail. Pet the dog gently, and avoid eye contact, particularly at first.
  • Never bother a dog that is sleeping, eating, or caring for puppies. Dogs in these situations are more likely to respond aggressively, even with a person who is familiar to them.
  • Do not allow your child to run past a dog, because dogs may be tempted to pursue the child.
  • Teach your child that if a dog is behaving in a threatening manner—for example, growling and barking—to remain calm, avoid eye contact with the dog, and back away slowly until the dog loses interest and leaves.
  • If you or your child is knocked over by a dog, curl up in a ball and protect the eyes and face with arms and fists.

For more information and what to do if a dog bites your child, visit healthychildren.org.

Infant Safety Classes

Unfortunately, babies do not come with directions! It is our job as parents to keep them safe. The Children’s Clinic would like to see how many parents would be interested in a child safety class that include topics such as:  CPR, sleeping positions, SIDS, and car seat safety.

If interested, please fill out the form below. You will be contact should we decide to offer a class like this.

Poison Prevention Week

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National Poison Prevention Week is March 16 – 22, 2014.

An estimated 90,000 children are treated in emergency rooms nationwide and about 30 die each year due to poison-related incidents. The good news, many of these poison-related incidents are preventable.

The first step in prevention is identifying poison danger. Nine out of ten times unintentional poisoning incidents occure in the home, and many involve commonly used medicines and household chemicals.  Simple steps such as keeping products in original containers, properly sealed after each use and stored up and away and out of child’s reach and sight can go a long way in preventing unintentional exposure. It is also important to know what to do in case of exposure.

For more information about poison awareness, download 50+ Poisoning Prevention Tips.

You can also like the Poison Prevent Week Council on Facebook or follow the hashtag #PreventPoison on twitter.

The Arkansas Poison Center’s website by The University of Arkanasas for Medical Sciences College of Pharmacy also has more information and a section to order free materials for your home.

Graco Harness Buckle Recall

From Graco:

Harness Buckle Recall – 2014 Announcement

As part of our continuous product testing and improvement process, Graco identified that food and dried liquids that can make some harness buckles progressively more difficult to open over time or become stuck in the latched position. Therefore, Graco has decided to conduct a voluntary recall on the harness buckles used on all toddler convertible car seats and harnessed booster seats manufactured from 2009 to July 2013. Graco would like to stress this does not in any way affect the performance of the car seat or the effectiveness of the buckle to restrain the child. And a car seat is always the safest way to transport your child.

Injuries Reported: 0

Number of Units Affected: 3.7 million

Dates Produced: 2009 through July 2013

MSRP: $99.00-$399.99

Models Affected: Toddler Convertible Car Seats: Cozy Cline, Comfort Sport, Classic Ride 50, My Ride 65, My Ride 70, My Ride 65 with Safety Surround, Size4Me 70, My Size 70, Head Wise 70, Smart Seat. Harnessed Booster Seats: Nautilus 3-in-1, Nautilus Elite and Argos.

Solution

Graco offers a new and improved replacement harness buckle to affected consumers at no cost. If you are experiencing difficulty with your harness buckle and cleaning has not improved its performance, please contact our Graco customer service team at 800-345-4109 (Monday through Friday from 9 a.m. until 5 p.m.) or consumerservices@gracobaby.com.

Cleaning Tips for Harness Buckles:

  • To clean your buckle, turn the restraint over and push the retainer through the harness strap slot. Place the buckle in a cup of warm water and gently agitate the buckle, pressing the red button several times while it is in the water.
  • Do not submerge the harness webbing and do not use soaps or lubricants, only rinse the harness buckle with warm water.
  • Shake out the excess water and allow the harness buckle to air dry.
  • Reattach the harness buckle into the same slot and re-check harness for correct installation according to the car seat manual before use.

Video Tips:

Cleaning Harness Buckles
Opening Harness Buckles
Replacing Harness Buckles

Download instructions for replacing buckles:

[note title=”For More Information” align=”center”]For more information, please visit Graco Baby’s website: http://www.pages02.net/newellrubbermaid/harness-buckles[/note]

Folic Acid Before and During Pregnancy

Folic acid is a B vitamin. If a woman has enough folic acid in her body before and during pregnancy, it can help prevent major birth defects of the baby’s brain and spine. Women need 400 micrograms (mcg) of folic acid every day.

[framed_box]Listen to the CDC’s Podcast: Folic Acid: Helping to Ensure a Healthy Pregnancy[/framed_box]