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Child Drug Safety Data Not Reaching Doctors

Manufacturers are conducting research, then burying the results, study suggests

TUESDAY, Sept. 12, 2006 (HealthDay News) -- Hundreds of common drugs may not be safe for children, but this information may not be reaching physicians, a new study finds.

A congressionally mandated program known as "pediatric exclusivity" allows the U.S. Food and Drug Administration (FDA) to extend the period of time a drug company holds exclusive marketing rights to a drug if that manufacturer conducts safety tests on the drug's use in children.

However, a report in the Sept. 13 issue of the Journal of the American Medical Association finds the results of these tests often don't reach physicians.

In the study, a team from Duke University Medical Center in Durham, N.C., tracked how often these test results were published in peer-reviewed scientific journals that would typically be read by physicians.

Between 1998 and 2004, fewer than half of the pediatric exclusivity studies were published, and the studies were less likely to be published if the drug was found to be unsafe or ineffective in children.

The pediatric exclusivity program was designed to increase knowledge about how children may react differently to commonly used drugs, such as antidepressants, anti-seizure medications and sedatives.

"Because children have different physiologies than adults, they often absorb drugs differently or experience different side effects," lead investigator Daniel K. Benjamin, a pediatrician at the Duke Clinical Research Institute, explained in a prepared statement.

"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," he added. "The results can be beneficial, harmful or not effective, depending on how much information about the use of the drug in the pediatric population is known."

The FDA mandates that findings from the pediatric exclusivity studies result in changes to the drug's label information. But Benjamin said that more can be done to make sure this information is getting into the right hands.

"Physicians are used to using peer-reviewed journals as a source for the latest medical information, so, it makes sense to get this information in there," he said.

More information

The Food and Drug Administration has more about drug safety.

SOURCE: Duke University News, news release, Sept. 12, 2006
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