Health Policy & Advocacy
Resources
Basic InformationMore InformationLatest News
Poor Whites Bear the Brunt of U.S. Opioid Crisis, Studies FindFDA to Tighten Oversight of SupplementsAs U.S. Measles Outbreaks Spread, Why Does 'Anti-Vax' Movement Persist?Even Brief EMS Delay Can Cost Lives After Car CrashHealth Tip: Know Your Family's Medical HistoryPatients With Primary Care Docs May Get Better Health CareIs Brexit a Health Hazard?Blood Donors Needed as Cold Weather Freezes U.S. SupplyMedical Scribes Could Help Improve ER CareAHA: Medical Experts 'Sound the Alarm' on Medical MisinformationWhite House Plan to Disclose Drug Prices May Not Drive Down Costs: StudyCan Artificial Intelligence Read X-Rays?Virtual Doctor Visits Get High Marks in New SurveyBig Pharma's Marketing to Docs Helped Trigger Opioid Crisis: StudyDisrupted Sleep Plagues Hospital Patients, But New Program Might HelpOpioid Prescriptions Almost Twice as Likely for Rural vs. Urban AmericansClimate Change Already Hurting Human Health, Review ShowsCalling All Blood Donors …Even Older Drugs Are Getting Steep Price Hikes, Study FindsAs Medical Marketing Soars, Is Regulation Needed?Radiation Doses From CT Scans Vary WidelyU.S. Leads Health Care Spending Among Richer Nations, But Gets LessIs Your State a Hotspot for Obesity-Linked Cancers?Health Tip: Choose the Right DoctorFDA Warns Companies on Dangerous, Unapproved Stem Cell TreatmentsMore U.S. Kids Dying From Guns, Car AccidentsRoad Rules on Smartphone Use Are Saving Bikers' Lives, TooAHA: Should Pacemakers, Defibrillators Be Recycled -- and Reused in Others?California Farm Tied to E. coli Outbreak Expands Recall Beyond Romaine LettuceHealth Tip: Use Medical Devices SafelyCalifornia Farm Implicated in Outbreak of E. coli Tied to Romaine LettuceFentanyl Now the No. 1 Opioid OD KillerHospitalizations Rising Among the HomelessElectronic Health Records Bogging Docs DownMore Are Seeking Mental Health Care, But Not Always Those Who Need It MostMillions of Americans Still Breathing Secondhand Smoke: ReportNew Approach to Opioid Crisis: Supervised Heroin Injection Programs?Many Americans Unaware of Promise of Targeted, 'Personalized' Medicine: PollAs Gun Violence Grows, U.S. Life Expectancy DropsMost Americans Lie to Their DoctorsOpioid Crisis, Suicides Driving Decline in U.S. Life Expectancy: CDCWant to Learn CPR? Try an Automated KioskHealth Surrogates Often in Dark About Loved One's WishesRestaurant 'Health Grade' Posters Could Mean Safer DiningSmoking Bans Might Help Nonsmokers' Blood PressureWarmer Winters, More Violent Crimes?Are Food Additives Good or Bad? Consumer Views VaryDrug Studies in Children Often Go Unfinished: StudyFDA Moves to Restrict Flavored E-Cig Sales, Ban Menthol CigarettesAgeism Costs Billions in Health Care Dollars
Questions and AnswersVideosLinksBook Reviews
Related Topics

Health Insurance
Healthcare

Drug Studies in Children Often Go Unfinished: Study

HealthDay News
by -- Robert Preidt
Updated: Nov 19th 2018

new article illustration

MONDAY, Nov. 19, 2018 (HealthDay News) -- Drug approvals for adults often require future studies in children, but many of these studies are never completed, a new analysis finds.

"More than 50 percent of all drugs approved by the FDA lack information on how to safely and effectively use the drug in children," said study author Dr. Florence Bourgeois, from the Pediatric Therapeutics and Regulatory Science Initiative at Boston Children's Hospital.

Her team examined 114 new drugs or new uses for drugs that were approved by the U.S. Food and Drug Administration between 2007 and 2014. In all, a total of 222 postmarketing studies in children were required for these approvals.

But only 34 percent of those studies had been completed by December 2017. Of those completed, only 45 percent had results reported in a journal.

At the time of FDA approval, only 16 percent of the drugs approved with postmarketing child studies had any information on child-related efficacy, safety or dosing on their labels. This rose to only 41 percent after an average follow-up of seven years.

"As a clinician, I was struck early on by how little evidence we often have to guide medication use in children. Although the FDA has an established process to ensure medicines are safe and effective in adults, this has historically been lacking for children," Bourgeois said in a hospital news release.

"Unfortunately, we are still seeing long delays between the approval of a drug and the availability of pediatric information. This perpetuates off-label drug use that may be unsafe or ineffective," she said.

Additional FDA oversight and use of enforcement tools are needed to ensure follow-up studies are completed, the researchers said.

The study was published Nov. 19 in the journal JAMA Pediatrics.

More information

The U.S. Food and Drug Administration has more on postmarketing clinical trials.




Facebook

Amazon Smile

To quit smoking, call Connecticut QuitLine at 1-800-QUIT-NOW.

Children and Adult services are available now with no wait time.  Please contact HBH Intake Department at 860-548-0101, option 2.

 


powered by centersite dot net