Skip 
Navigation Link

1215 South Walnut Ave.
Demopolis, AL 36732 map map 

Access to Care: 334.289.2410

Health Policy & Advocacy
Resources
Basic InformationMore InformationLatest News
Bans on Texting While Behind the Wheel Making Roads SaferColorado Sees Spike in ER Visits After Pot Made LegalMajor Medical Groups Call for Soda TaxesCould the U.S. Mail Deliver Better Colon Cancer Screening Rates?Opioid Rxs Decreasing, But Not for All DoctorsAfter Chinese Infant Gene-Editing Scandal, U.S. Health Officials Join Call for a BanAre 'Inactive' Ingredients in Your Drugs Really So Harmless?Need to Be Vaccinated? Try Your Local PharmacyBystanders Key to Cutting Cardiac Arrest DeathsMany Black Americans Live in Trauma Care 'Deserts'FDA Issues Asbestos Warning About Some Claire's Cosmetic ProductsFDA to Crack Down on Retailers That Keep Selling Tobacco to KidsBlood Donation by Teen Girls May Raise Anemia RiskNurses' Long Hours, Moonlighting Could Pose Patient Safety RiskBerkeley's Efforts Suggest Soda Taxes Do Cut Soda SalesOpioid Overdose Deaths Quadruple, Centered in 8 StatesPayments for Research Can Lead to Lies: StudyFDA Aims to Strengthen Sunscreen RulesAre Primary Care Doctors Prepared to Discuss Cancer Treatment?FDA Fell Short in Preventing Fentanyl Abuse Crisis, Report ClaimsPrimary Care Doctors Help Boost Life Spans, But More Are NeededMore Car Crashes Tied to Drivers High on OpioidsPoor 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 CareBlood Donors Needed as Cold Weather Freezes U.S. SupplyAHA: 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 Safely
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.