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Pediatric Seizure Study Underway in US to Decide Between Diazepam and Lorazepam

dent reviewers will look for overall trends in study data. If it becomes clear that one drug is more effective at treating seizures, the study will be ended early.

We have consulted a wide range of ethicists, experts and government officials about this study to ensure that we protect patients safety, Dr. Baren said.

The researchers have designed a public information campaign to inform the public about the study in the various communities where it will be performed, Dr. Baren said. They will hold community meetings to provide information about the study to all interested families that might be included in the study. During the meetings they will answer questions and listen to concerns of community members.

Dr. Baren stressed the importance of proper research on all emergency treatments to be sure of their effectiveness. The FDA has emphasized the need to test all drugs used for children so that those used are known to be safe and effective.

The NICHD is funding the study in accordance with the Best Pharmaceuticals for Children Act (BPCA), explained Donald Mattison, Chief of the Obstetric and Pediatric Pharmacology Branch. Under the BPCA, the NIH consults with the U.S. Food and Drug Administration to determine which approved drugs should be prioritized for further testing in children. Dr. Mattison added that roughly two-thirds of drugs prescribed for children have never been specifically tested in children.


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