Many New Drugs Not Adequately Tested in Children

Many New Drugs Not Adequately Tested in Children
Many New Drugs Not Adequately Tested in Children
Last updated:

Many new drugs that are used in children were never actually tested on them or approved for them prior to hitting the market. And while the FDA has required that drugmakers conduct postmarket pediatric clinical trials on many of these medications, only about a third such studies have actually been completed.

The lack of these studies, say researchers, is a problem because these treatments may not be effective in children; doctors may be hesitant to prescribe them due to the missing data; and a concern that off-label use of medications is linked to increased drug reactions in children.

The Pediatric Research Equity Act (PREA), signed into law in 2003, gave the FDA authority to require that drugmakers evaluate the safety and efficacy of new drugs in different pediatric populations. Although the law expected the pediatric studies would be submitted prior to approval, it allowed companies in certain circumstances to delay the studies until after approval.

Between 2007 and 2014, the FDA approved 114 new drugs or new indications for drugs already on the market that were subject to PREA, and required 222 pediatric studies for them. However, only 75 studies – 33.8% – after an average follow-up of about seven years, according to a new study published in JAMA Pediatrics. The researchers also noted that most new drug labels do not include information related to pediatric drug use. Only about 41% include any pediatric information on the label.

DISCLAIMER: MedShadow provides information and resources related to medications, their effects, and potential side effects. However, it is important to note that we are not a substitute for professional medical advice, diagnosis, or treatment. The content on our site is intended for educational and informational purposes only. Individuals dealing with medical conditions or symptoms should seek guidance from a licensed healthcare professional, such as a physician or pharmacist, who can provide personalized medical advice tailored to their specific circumstances.

While we strive to ensure the accuracy and reliability of the information presented on MedShadow, we cannot guarantee its completeness or suitability for any particular individual's medical needs. Therefore, we strongly encourage users to consult with qualified healthcare professionals regarding any health-related concerns or decisions. By accessing and using MedShadow, you acknowledge and agree that the information provided on the site is not a substitute for professional medical advice and that you should always consult with a qualified healthcare provider for any medical concerns.

Recommend More Articles Like This?

Show Comments (0)
0 0 votes
Article Rating
Notify of
Inline Feedbacks
View all comments
Would love your thoughts, please comment.x