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Post-marketing studies finding adverse events in drugs used in children
Date:9/1/2008

ics are evaluating the data. That's what's so unique about this effort."

The majority of the 67 drugs studied (65.7 percent) did not appear to cause enough adverse events to require continued pediatric monitoring. However, nearly one in five drugs studied required label changes consisting of additional warnings and cautions for use in children, and several of the adverse events revealed during this process were considered life threatening. Some of those labeling changes included:

  • Black Box warning and development of patient information for selective serotonin reuptake inhibitors (SSRIs) regarding potential for suicidality and neonatal toxicity/withdrawal syndrome.

  • Box warning for transdermal opioid analgesis (Duragesic) alerting that inappropriate use may result in serious adverse reactions, including death.

  • Labeling change for methylphenidate (Concerta) to address the potential for psychiatric events.

The Duke researchers say their findings support the approach that pediatric post-marketing surveillance is crucial, and that physicians, nurses, parents and others should take the job of reporting adverse effects seriously. Very rare serious adverse events are seldom defined during a study of a few hundred children and learning about these events is often dependent on the reporting of them from caretakers and parents.

"Unfortunately, few clinicians and patients know this reporting system exists," says Smith. "In the Duke Neonatal Intensive Care Unit, the pharmacist reports adverse drug events to MedWatch. But I'm not sure that happens at every hospital. A lot of physicians don't know it's available. This publication is somewhat of an advertisement that this program is available."

Smith urges parents to report adverse reactions they see. The FDA does not release any confidential information provided. Nor do the parents have to be certain that a drug exposure was t
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Contact: Debbe Geiger
Debbe.Geiger@duke.edu
919-660-9461
Duke University Medical Center
Source:Eurekalert

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