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Doctors Unaware If Pediatric Dosages Are Safe

Drugs prescribed to children are not checked properly for their safety and efficacy, says a new study by Duke University Medical Center researchers. // The drugs that are being indiscriminately prescribed include antidepressants, antiseizure medications and sedatives.

The researchers analyzed drugs covered by a "congressionally mandated program known as "pediatric exclusivity," through which the Food and Drug Administration (FDA) may extend the period of time that a company holds exclusive marketing rights for a drug -- thereby delaying the entry of competing generic drugs -- if the manufacturer conducts FDA-requested trials on its use in children.

The researchers looked at how often the results of such studies were published in peer-reviewed scientific journals, often cited as among the most effective ways to communicate information to the medical community. Fewer than half of the pediatric exclusivity studies were published, the researchers found, and the results were less likely to be published if the drug was deemed unsafe or ineffective in children.

"Because children have different physiologies than adults, they often absorb drugs differently or experience different side effects," said the study's lead investigator, Daniel K. Benjamin, M.D., Ph.D., a pediatrician at the Duke Clinical Research Institute who also holds an appointment at the FDA's Office of Pediatric Therapeutics. "Much of pediatric drug use is done 'off label,' meaning that children are often treated based on what has been shown to be effective in older patients, and the results can be beneficial, harmful or not effective, depending on how much information about use of the drug in the pediatric population is known."

The FDA designed the pediatric exclusivity program to increase knowledge about how children may react differently to commonly used drugs that have not been previously studied in the pediatric population. Based on their study the Duke res
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