24-Hour Crisis Hotline: (877)SAFEGBC or (877)723-3422 Mental Health & Substance Abuse Issues

6502 Nursery Drive, Suite 100
Victoria, TX 77904
(361)575-0611
(800)421-8825
Fax: (361)578-5500

Child & Adolescent Development: Overview
Resources
Basic InformationMore InformationLatest News
How to Keep Halloween Fun and SafeFor Kids With Genetic Condition, Statins May Be LifesaversNone of Top-Selling Kids' Drinks Meet Experts' Health RecommendationsChildhood Risk Factors Can Predict Adult ObesityA Parent's Guide to Managing Kids' Asthma During the FallFarm-to-Table Movement Goes to SchoolAHA News: High Triglycerides Caused a Diet Change – at Age 10Kids + Gadgets = Less Sleep and More Risk for Unwanted WeightCause of Paralyzing Illness in Kids Remains ElusiveHealth Tip: Preventing Backpack InjuriesFor Kids With Asthma, Depression Makes ER Visit More LikelyFor Poor Kids, Less Time Spent on Reading, Exercise: StudyTrain Tracks Deadly for Kids, But Many Parents Underestimate the DangerAll That Screen Time Won't Hurt Your Kid's Grades - MaybeDoes Parents' Smoking Raise Future Heart Risks for Kids?Anemia During Pregnancy Tied to Higher Odds for Autism, ADHD in KidsParents, Throw the Garden at Your Picky EaterA Good Night's Sleep Is Key to School SuccessHealth Tip: Helping Children Adjust to a MoveKids Often Prescribed Drugs 'Off-Label,' Raising ConcernsExperts' Guide to Trampoline SafetyDon't Let Kids Wander Alone in Parking LotsMost U.S. Parents Say Vaccination Should Be Requirement for School: PollIf a Child's Schoolwork Slips, Don't Rule Out Hearing LossNurturing Childhood Boosts Odds of a Happy Adult Life: StudyKids in Poor Neighborhoods Face Higher Odds for Obesity as AdultsA Prescription for Medicating Your Child SafelyIs a Charter School the Right Choice for Your Child?Health Tip: Mental Illness Warning SignsAn Easy Recipe for Healthier Back-to-School LunchesAHA News: Understanding Connection Between Poverty, Childhood Trauma and Heart DiseaseHealth Tip: Staying Well During the School YearBackpacks Shouldn't Be a Back-to-School Burden on HealthA Kid-Friendly Emergency Room Saves LivesMany Parents Would Switch Doctors Over Vaccination Policy, Poll FindsAs School Starts, Pack That Lunch With Nutritional Goodies5 Health Tips to Promote Back-to-School SuccessPot Poisonings Among Kids, Teens Double After Medical Marijuana Law PassedFor Kids Born With HIV, Taking Needed Meds Gets Harder With Age: StudyBuilding a Better BackpackKids Getting Too Many Opioids After TonsillectomyExplaining, Easing the Horror of Mass Shootings for Your KidsFor Kids With Asthma, Allergies, New School Year Can Bring Flare-UpsAnother Video Game Risk to Watch Out ForOlder Parents May Have Better Behaved KidsAre Too Many Kids Prescribed Antihistamines?Childhood Cancer Steals Over 11 Million Years of Healthy Life: StudyFamily Home, Football Field Most Dangerous Spots for Kids' Head InjuriesMost Airplanes Not Equipped With First Aid for KidsPlastics Chemicals Meant to Replace BPA May Not Be Any Safer for Kids
Questions and AnswersLinks
Related Topics

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

Kids Often Prescribed Drugs 'Off-Label,' Raising Concerns

HealthDay News
by By Serena Gordon
HealthDay Reporter
Updated: Sep 16th 2019

new article illustration

MONDAY, Sept. 16, 2019 (HealthDay News) -- When a child gets sick, doctors are increasingly relying on what's known as "off-label" use of medications, a new study says.

Off-label use of a drug means that it hasn't been specifically studied and approved for the condition, age group or weight of the person getting the prescription.

For example, kids with asthma may be prescribed antihistamines (approved for allergies, but not specifically for asthma), because they may have allergies that trigger their wheezing, the researchers noted.

The study found that doctors prescribed one or more off-label drugs for children in almost 1 out of every 5 office visits.

"Off-label doesn't mean a drug is harmful. There's often good evidence behind the use of off-label drugs," said study senior author Dr. Daniel Horton. He's an assistant professor of pediatrics and epidemiology at the Rutgers Robert Wood Johnson Medical School in New Brunswick, N.J.

"But sometimes there isn't good evidence, so it's important for parents to discuss with the child's doctor what is known and not known about off-label drugs, so they can try to ensure that the benefits of a drug outweigh the risks," Horton said.

Doctors often turn to off-label drug use because no alternative exists, the authors said.

"Historically, children have been excluded from clinical trials of medications. This left a large gap in knowledge. Over time, legislation and policies to require more research have been developed," Horton said.

The study is being published in the October issue of the journal Pediatrics, available online Sept. 16.

Dr. Rudolph Valentini, chief medical officer at Children's Hospital of Michigan in Detroit, agreed that drug trials in children can be challenging.

He said sometimes parents don't want their children involved in drug research trials. Another issue, he noted, is that "some diseases are just less common in children," such as high blood pressure. Valentini was not involved with the new study.

Horton and his colleagues used nationally representative surveys from doctors' offices, including about 1.74 billion visits for children under 18. During these visits, 18.5% of children were given a prescription for one or more off-label drugs.

That means more than 41 million off-label drugs were ordered for children each year, the researchers said.

Off-label drug use was most common in teens and least common in newborns. However, when newborns needed medications, they were prescribed an off-label drug 83% of the time.

Girls were more likely to receive off-label prescriptions, as were patients in the South. Children and teens with chronic conditions and those who needed more than one type of medication were also more likely to be given an off-label prescription.

The types of drugs most commonly prescribed off-label to children under 18 were antihistamines (allergy medications), antibiotics and antidepressants. Antihistamines and antibiotics were often prescribed for respiratory infections, the researchers said. Antidepressants were often prescribed to treat attention deficit hyperactivity disorder.

"Pediatricians and other doctors that care for children are doing the best they can with the best evidence available. Almost all of the medications used off-label in children have a long track record in the adult world," Valentini explained.

And, he said, doctors are prescribing the medications because they believe their benefit outweighs the risk.

For example, if a baby is in intensive care and needs an off-label sedative because of a painful condition, Valentini said doctors are concerned that a drug might affect the growing brain, but not treating the pain wouldn't be good for the child either.

"Every decision we make weighs risk versus benefits. If it's not clear, we will have a serious conversation with the family. Parents should always ask questions and be the advocate for their child. Your child's doctor should be happy to explain why they've chosen a particular medicine," Valentini said.

Horton said the findings highlight the need for more research and more effective policies to encourage that research.

More information

The U.S. Food and Drug Administration explains more about off-label drug use.