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
Will Your Kid Play School Sports This Fall? Here's Some Guidance on Doing It SafelyU.S. Grandparents Are Raising Millions of Kids, and It's ToughMysterious Paralyzing Illness in Kids Is Set to Return, CDC WarnsSchools Can Reopen Safely If Precautions in Place, Australian Study ShowsKids 'Efficient' Transmitters as COVID-19 Raced Through a Georgia Summer CampIn NYC at Least, Routine Child Vaccinations Rebound After LockdownNew Study Sheds Doubt on Notion Kids Aren't COVID-19 SpreadersSpanking on the Decline in American HomesParents: Sharpen up on Your Sunscreen KnowledgeCDC Issues Call to Reopen America's Schools This FallBlack Kids Face Higher Odds of Post-Op Complications Than White KidsLoss of a Twin Linked to Risk for Mental IllnessObesity in Childhood Quickly Harms Heart HealthSleep Problems in Early Childhood Linked to Teens' Mental Health IssuesPot Use in Pregnancy Could Mean Sleepless KidsWith Social Distancing, Schools Should Be Safe to Reopen This Fall, Experts SayThe Long-Term Harm of Missing SchoolHow the Pandemic Is Changing Summer CampHealthier School Meal Programs Helped Poorer Kids Beat Obesity: StudyWith Pandemic-Related Stress, Abuse Against Kids Can SurgeKeep Your Kids Safe in the Water. Here's HowMultiple Surgeries for Cleft Lip, Palate Won't Cause Major Psychological Damage2 in 3 Parents Would Send Kids to School in Fall: SurveySigns of Developing Adult Diabetes Seen as Early as Age 8: StudyVaccine Might Guard Against Bacteria That Cause Diarrhea in KidsShould You Send Your Kid to Summer Camp? Expert Offers AdvicePractice Gun Safety for Your Kids' Sake, Especially During PandemicAsthma More Likely in Kids With Disabilities, DelaysDon't Let COVID-19 Scuttle Your Child's Health ExamsAbout 1 in 15 Parents 'Hesitant' About Child Vaccines: SurveyHome Alone: Will Pandemic's Changes Harm Kids' Mental Health Long-Term?Concussion Can Lead to Vision, Balance Problems in Young KidsAHA News: Finding Balance Between the Good of Youth Sports and Risks of COVID-19Black Children Hit Especially Hard by COVID-19 Inflammatory SyndromeKids Breaking Fewer Bones During Pandemic, But More Fractures Happening at HomeSimilar to Adults, Obesity Raises Kids' Odds for Severe COVID-19Are Food Allergies Under-Diagnosed in Poor Families?Stay-at-Home Orders Could Mean More Obese Kids: StudyWhere Are Kids Getting the Most 'Empty Calories'?AHA News: For Kids, a Pandemic of Stress Could Have Long-Term Consequences6 Expert Tips for Defusing Kids' Quarantine MeltdownsFor Many Kids, Picky Eating Isn't Just a Phase, Study FindsSure-Fire Solutions for Managing Lockdown Temper TantrumsKeeping Kids Slim, Fit During Lockdown Isn't Easy: Here Are Some TipsCOVID-19 Antibodies May Tame Inflammatory Condition in Kids: StudyCould Certain Chemicals Trigger Celiac Disease?Italian Doctors Detail Cases of Inflammatory Condition in Kids With COVID-19AHA News: Is Your Child's Blood Pressure Something to Worry About?Zika Virus Tied to Profound Developmental DelaysCOVID-19 Still Rare in Kids, But Far From Harmless: Study
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.