bannerHON
img
HONnews
HONnews
img PATIENT / PARTICULIER img PROFESSIONNEL DE SANTE img WEBMESTRE img
img
 
img
HONcode sites
All Web sites
HONselect
News
Conferences
Images

Themes:
A B C D E F G H I
J K L M N O P Q
R S T U V W X Y Z
Browse archive:
2014: A M F J
2013: D N O S A J J M A

 
  Other news for:
Child
 Resources from HONselect
Drug Labels Still Lack Infant Info, Study Finds
Research to measure effects on newborns may be needed, researchers say

By Robert Preidt

MONDAY, Dec. 9, 2013 (HealthDay News) -- Drug labels often lack infant-specific information, despite U.S. government legislation encouraging drug studies involving children, a new study finds.

The research focused on neonates, who are infants up to 28 days of age. They are at high risk for harmful effects from drugs. The unique ways in which their bodies work makes it difficult to determine how drugs might affect them by analyzing data involving older patients, according to background information in the study.

"The scientific and clinical research community will need to work together with the FDA to conduct essential neonatal studies," said Dr. Matthew Laughon, of the University of North Carolina at Chapel Hill, and colleagues.

The researchers reviewed 28 drug studies that included neonates and were conducted as a result of federal legislation, along with 24 related labeling changes.

The results showed that 11 of the 24 neonatal labeling changes made it clear that the drug was approved for use in neonates.

The investigators also found that 13 of the 28 drugs were not used in neonatal intensive care units and that eight of the drugs were used in fewer than 60 neonates, according to the study published online Dec. 9 in the journal JAMA Pediatrics.

"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," Laughon and colleagues wrote in a journal news release.

"Education of parents and caregivers regarding the need for studies of drugs being given to neonates will also increase trial success," they added.

More information

The U.S. National Library of Medicine has more about children and medicines.

SOURCE: JAMA Pediatrics, news release, Dec. 9, 2013

Copyright © 2013 HealthDay. All rights reserved. URL:http://consumer.healthday.com/Article.asp?AID=682847

Resources from HONselect: HONselect is the HON's medical search engine. It retrieves scientific articles, images, conferences and web sites on the selected subject.
Specialty Chemicals and Products
Research Personnel
Intensive Care
Caregivers
Affect
The list of medical terms above are retrieved automatically from the article.

Disclaimer: The text presented on this page is not a substitute for professional medical advice. It is for your information only and may not represent your true individual medical situation. Do not hesitate to consult your healthcare provider if you have any questions or concerns. Do not use this information to diagnose or treat a health problem or disease without consulting a qualified healthcare professional.
Be advised that HealthDay articles are derived from various sources and may not reflect your own country regulations. The Health On the Net Foundation does not endorse opinions, products, or services that may appear in HealthDay articles.


Home img About us img MediaCorner img HON newsletter img Site map img Ethical policies img Contact