Call 413.540.1234 to
schedule an appointment
CONCERN/EAP: 413.534.2625
Billing questions? Call: 413.540.1212
CRISIS: 413.733.6661

Child & Adolescent Development: Overview
Resources
Basic InformationMore InformationLatest News
Learning Problems May Accompany Kidney DiseasePoorer Kids May Fare Worse After Heart SurgeryGuns Still Found in Homes With Unstable KidsSibling Bullying Tied to Increased Odds of Psychotic DisorderSibling Bullying Could Have Mental Health EffectsHealth Tip: Ski and Snowboard Safely With Your KidsKids Who Need Sickle Cell Meds Don't Always Get ThemAfter Another Shooting Tragedy, 'Stop the Bleed' Kits Urged for SchoolsParents Find Kids' Weight Report Cards Hard to SwallowFood Allergies: To Test or Not to TestHealth Tip: Prevent Exposure to LeadHey Kids, Just Say No to Energy DrinksHead Injuries Hit 1 in 14 Kids, CDC Reports2018 Immunization Schedule Issued for U.S. ChildrenKids Can Roll Up Their Sleeves -- Again -- for Mumps ProtectionFetal Alcohol Cases More Common Than Thought: StudyEasing Your Child's AsthmaHealth Tip: X-Ray Suggestions for ParentsIf You Suspect a Child Is Being Abused or Neglected, Report ItPersistent Respiratory Issues in Youth May Decline Lung FunctionPostnatal Depression Tied to Child Behavioral ProblemsFit Kids Have Healthier Lungs as Adults: StudyFew Prescription Meds Have Dosing Guidelines for Obese KidsHealth Tip: Encourage Your Child to be ActivePositive Attitude Adds Up to Better Math GradesReview: Lower Cognitive Scores for HIV+, HIV-Exposed ChildrenA Sleepy Child Is More Likely to Pile on PoundsCan't Pay the Rent? Kids' Health May SufferRepeat BP Reading Needed in Children With Initial High ResultDon't Rely on Just One Blood Pressure Test for Kids: StudyFrom Birth On, One Sex Is HardierHealth Tip: Talk to Your Youngster About AdoptionFor Kids, Chronic Illness May Trigger Mental Health IssuesGrandparents Help Shape Kids' Views on AgingPrenatal PPI, H2 Blocker Use Linked to Asthma Risk in ChildAs CHIP Money Runs Out, Millions of U.S. Kids May Lose Health CarePsoriasis Is Independent Risk Factor for Comorbidity in ChildrenFDA Bans Use of Opioid-Containing Cough Meds by KidsSchool-Based Telemedicine Asthma Management Is EffectiveAcetaminophen in Pregnancy Tied to Language Delays -- in One SexIs Surgery Riskier for Black Children?Mental Disorders Common in Kids With Chronic Physical ConditionsIs Your Child Ready for a Smartphone?What to Do if Your Child Has ChickenpoxChild Death Rate Higher in U.S. Than Other Wealthy NationsThe Opioid Crisis' Hidden Victims: Children in Foster CareApple Investors Press for Parental Controls on iPhonesSpike Seen in Kids' Eye Injuries From BB, Paintball GunsFewer of America's Poor Kids Are Becoming ObeseRespiratory Virus Lurks as Wintertime Worry
Questions and AnswersLinksBook Reviews
Related Topics

ADHD: Attention Deficit Hyperactivity Disorder
Childhood Mental Disorders and Illnesses
Parenting
Child Development & Parenting: Infants (0-2)
Child Development & Parenting: Early (3-7)
Child Development & Parenting: Middle (8-11)
Childhood Special Education

FDA Bans Use of Opioid-Containing Cough Meds by Kids

HealthDay News
by -- E.J. Mundell
Updated: Jan 11th 2018

new article illustration

THURSDAY, Jan. 11, 2018 (HealthDay News) -- Trying to put a dent in the ongoing opioid addiction crisis, the U.S. Food and Drug Administration on Thursday slapped strict new restrictions on the use of opioid-containing cold and cough products by kids.

These prescription medicines involve any that include codeine or oxycodone, the FDA said.

"After safety labeling changes are made, these products will no longer be indicated for use to treat cough in any pediatric population and will be labeled for use only in adults aged 18 years and older," the FDA said in a news release.

The newly updated Boxed Warning on these medicines will also warn adult users "about the risks of misuse, abuse, addiction, overdose and death, and slowed or difficult breathing that can result from exposure to codeine or hydrocodone," the agency added.

"Given the epidemic of opioid addiction, we're concerned about unnecessary exposure to opioids, especially in young children. We know that any exposure to opioid drugs can lead to future addiction. It's become clear that the use of prescription, opioid-containing medicines to treat cough and cold in children comes with serious risks that don't justify their use in this vulnerable population," FDA Commissioner Dr. Scott Gottlieb said in the news release.

"It's critical that we protect children from unnecessary exposure to prescription cough medicines containing codeine or hydrocodone," he added. "At the same time we're taking steps to help reassure parents that treating the common cough and cold is possible without using opioid-containing products."

The move comes after a 2017 decision by the FDA to add its strongest warning -- a "contraindication" -- to labeling for prescription products containing codeine. That labeling restricted use to children aged 12 and over "due to a specific risk of ultra-rapid metabolism in certain patients," the FDA explained.

The new rules announced Thursday were "based on an extensive review of available data and expert advice," the agency said.

They go much further than the 2017 labeling rules -- restricting use of codeine-containing products to everyone under the age of 18, and including cough-and-cold products that contain a second drug, the opioid oxycodone.

In any case, there's little that can or should be done to ease most children's cough and colds, the FDA said.

"Experts indicated that although some pediatric cough symptoms do require treatment, cough due to a cold or upper respiratory infection typically does not require treatment," the agency said. "Moreover, the risks of using prescription opioid cough products in children of all ages generally outweigh the potential benefits."

The FDA pointed to known side effects of opioid medications, including "drowsiness, dizziness, nausea, vomiting, constipation, shortness of breath and headache."

One physician who's dealt with the aftermath of opioid overuse applauded the move.

"It's commendable that the FDA is acting to expand safety use labeling not only for children and teens, but adults as well," said Dr. Robert Glatter, an emergency physician at Lenox Hill Hospital in New York City.

"The opioid epidemic has many origins, but can begin with exposure to [opioids] at young ages," he said. "We know that some children and teens may, in fact, develop a predilection for the 'high' the prescription cough syrups deliver, and subsequently attempt to deceive parents and health care providers regarding the severity of their symptoms to obtain such a prescription."

So what's the advice for parents who may be using these medicines for their child already? According to the FDA, they should talk to their child's doctor about alternative therapies.

It's always important to read medicine labeling, too -- even if it's not obtained by prescription.

"Caregivers should also read labels on non-prescription cough and cold products," the FDA said, because "some products sold over-the-counter in a few states may contain codeine or may not be appropriate for young children."

More information

There's more about this issue at the American Academy of Pediatrics.