Featured Research

from universities, journals, and other organizations

Study examines drug labeling, exposure in infants

Date:
December 9, 2013
Source:
American Medical Association (AMA)
Summary:
Federal legislation encouraging the study of drugs in pediatric patients has resulted in very few labeling changes that include new infant information, according to a study.

Federal legislation encouraging the study of drugs in pediatric patients has resulted in very few labeling changes that include new infant information, according to a study by Matthew M. Laughon, M.D., M.P.H., of the University of North Carolina at Chapel Hill, and colleagues.

Neonates (infants up to 28 days of age) are at high risk of drug-related adverse events and their unique physiology makes it hard to extrapolate data on drugs from older patients. Drug labeling often has insufficient information on the safety, efficacy or dosing that is appropriate for children, in part because there are few drug trials in neonates, according to the study background.

Researchers reviewed drug studies that included neonates, as a result of legislation, and assessed the types of drug labeling changes, if any, that were made. They reviewed Food and Drug Administration (FDA) databases and identified 28 drugs studies in neonates and 24 related labeling changes.

Study findings indicate 11 (46 percent) of the 24 neonatal labeling changes made clear the drug was approved for use in neonates on the basis of safety and effectiveness. Researchers then found that most of the studied drugs were not used in neonatal intensive care units (NICUs), with 13 (46 percent) of the 28 drugs studied in neonates not used and 8 (29 percent) of the drugs used in fewer than 60 neonates.

"Because of these challenges of performing clinical trials in infants, few labeling changes have included infant-specific information. Novel trial designs need to be developed and appropriate study end points must be identified and validated," the study concludes. "Education of parents and caregivers regarding the need for studies of drugs being given to neonates will also increase trial success. The scientific and clinical research community will need to work together with the FDA to conduct essential neonatal studies."


Story Source:

The above story is based on materials provided by American Medical Association (AMA). Note: Materials may be edited for content and length.


Journal Reference:

  1. Matthew M. Laughon, Debbie Avant, Nidhi Tripathi, Christoph P. Hornik, Michael Cohen-Wolkowiez, Reese H. Clark, P. Brian Smith, William Rodriguez. Drug Labeling and Exposure in Neonates. JAMA Pediatrics, 2013; DOI: 10.1001/jamapediatrics.2013.4208

Cite This Page:

American Medical Association (AMA). "Study examines drug labeling, exposure in infants." ScienceDaily. ScienceDaily, 9 December 2013. <www.sciencedaily.com/releases/2013/12/131209160704.htm>.
American Medical Association (AMA). (2013, December 9). Study examines drug labeling, exposure in infants. ScienceDaily. Retrieved September 1, 2014 from www.sciencedaily.com/releases/2013/12/131209160704.htm
American Medical Association (AMA). "Study examines drug labeling, exposure in infants." ScienceDaily. www.sciencedaily.com/releases/2013/12/131209160704.htm (accessed September 1, 2014).

Share This




More Health & Medicine News

Monday, September 1, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Get on Your Bike! London Cycling Popularity Soars Despite Danger

Get on Your Bike! London Cycling Popularity Soars Despite Danger

AFP (Sep. 1, 2014) Wedged between buses, lorries and cars, cycling in London isn't for the faint hearted. Nevertheless the number of people choosing to bike in the British capital has doubled over the past 15 years. Duration: 02:27 Video provided by AFP
Powered by NewsLook.com
We've Got Mites Living In Our Faces And So Do You

We've Got Mites Living In Our Faces And So Do You

Newsy (Aug. 30, 2014) A new study suggests 100 percent of adult humans (those over 18 years of age) have Demodex mites living in their faces. Video provided by Newsy
Powered by NewsLook.com
Liberia Continues Fight Against Ebola

Liberia Continues Fight Against Ebola

AFP (Aug. 30, 2014) Authorities in Liberia try to stem the spread of the Ebola epidemic by raising awareness and setting up sanitation units for people to wash their hands. Duration: 00:41 Video provided by AFP
Powered by NewsLook.com
California Passes 'yes-Means-Yes' Campus Sexual Assault Bill

California Passes 'yes-Means-Yes' Campus Sexual Assault Bill

Reuters - US Online Video (Aug. 30, 2014) California lawmakers pass a bill requiring universities to adopt "affirmative consent" language in their definitions of consensual sex, part of a nationwide drive to curb sexual assault on campuses. Linda So reports. Video provided by Reuters
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:
from the past week

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins