Regulatory Focus™ > News Articles > Study: Most Drugs Lacking Information on Adequate Pediatric Use

Study: Most Drugs Lacking Information on Adequate Pediatric Use

Posted 09 May 2012 | By

A study conducted by researchers at the US Food and Drug Administration (FDA) finds fewer than half of all pharmaceutical products on the market do not contain any information for how the drug should be used safely in pediatric populations, reports Reuters.

The study, published in the Journal of the American Medical Association, notes just 46% of products listed in the electronic Physicians' Desk Reference contained information to ensure safe pediatric use, notes Med Page Today.

Of the 560 drugs studied by Dr. Dianne Murphy and her colleagues, just 231 of the drugs were labeled with pediatric information, while another 29 had incomplete information. The remainder of the drugs-54%-did not have age-specific information, reports Reuters.

While those numbers are a vast improvement to the period before the Pediatric Research Equity Act (PREA) and the Best Pharmaceuticals for Children Act (BPCA) were passed, much work remains to be done, said Murphy.

"Children are routinely being given products that are not studied in them," said Murphy.

The study's finding closely mirrors that of the Institute of Medicines' (IOM) February 2012 FDA-commissioned report, Safe and Effective Medicines for Children: pediatric Studies Conducted Under BPCA and PREA.

The report found while there was a marked increase in the number of drugs studied in pediatric populations, several improvement could be made. The report recommended FDA require sponsors to conduct long-term follow-up clinical trials in children more frequently and address other areas where pediatric testing is lacking.


Read more:

Reuters - Many drug labels missing dose, safety info for kids

Med Page Today - Drug Info on Pediatric Use Still Lacking

ABC - How Do Docs Prescribe Kids' Meds? Guess

Regulatory Focus - IOM: Legislation Has Led To Safer Medicines For Children, More Work Needed

Regulatory Focus - Study: Pediatric Clinical Trials Guilty of Publication Bias, NIH Falling Short of Obligations

Regulatory Focus - Senators Release Plan to Improve Pediatric Device, Drug Safety

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe