Next time you examine prescription drug information for a child, chances are that suitable safety or dosing data will be lacking. Why? A new study by FDA staffers found that only 231 medicines of 461 listed in the Physicians Desk Reference had adequate information that doctors would need to prescribe a drug to children. The study appears in the Journal of the American Medical Association (
read the extract).The findings are an improvement over a 1975 study that found only 22 percent of labeling was sufficient. And of new molecular entities approved between 1999 to 2009, those with pediatric labeling increased from 20 percent to 41 percent. Nonetheless, the authors say the lack of data is disturbing. “You can’t get a product approved in adults without studying how it affects them first,” Dianne Murphy, one of the authors, tells ABC News. “But children are routinely being given products that are not studied in them.”
The researchers analyzed labels of 560 different drugs used to treat a variety of ailments, everything from high blood pressure to allergies. They found 231 were properly labeled and 29 had useful info for some age groups. That meant 54 percent of labels lacked pediatric info. After excluding 100 drugs not deemed relevant to children, 44 percent of the drugs lacked sufficient labeling.
A contributing factor are hurdles to conducting pediatric studies and lack of evidence means doctors must extrapolate dosing information. "The number of children available with a disease is usually less, and there are very real challenges to doing research on therapy for children ethically," Eric Lavonas, from the Rocky Mountain Poison and Drug Center, tells Reuters.
This means that proper labeling information is often lacking for diseases that are less common in children. "Kids are mostly healthy but they still get heart disease, they still get lung disease, they still get endocrine disease, they still get arthritis, they still get many of the diseases that adults get -- and it's in those populations that we can't get things studied," Murphy tells Reuters. The answer? The authors says there must be legislation to increase pediatric clinical trials and require that information is added to labeling.
10 Comments
1)0-12 months 2)12 months to two years 3)two years to 12 years 4)12-18 years
From my review of other programs ours was one of the most challenging, but we got it done.
Compared to our recruitment challenges you can find obese 5 year olds by walking into any Baskin Robbins store around.
Pediatric Labeling and Extrapolation rule 1994 FDA Modernization Act 1997 Best Pharmaceuticals for Children Act 2002 Pediatric Research Equity Act 2003 (2007)
All of these basically extended the patent protection on innovator drugs (and certain generic drugs) if they, the pharma co., did additional research on children. But as noted above, children are children and these acts have had mixed results ... it's hard to recruit children-patients, expensive, and has limited upside potential with a downside as well ... therefore the acts have not had the impact that was expected.