AAP Commends FDA On Approval Of Pralidoxime For Pediatric Use

Main Category: Pediatrics / Children's Health
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 13 Sep 2010 - 3:00 PDT


The American Academy of Pediatrics issued the following statement regarding the Food and Drug Administration's (FDA) approval of pediatric use of Protopam Chloride (pralidoxime chloride), a drug to treat poisoning by organophosphate pesticides and chemicals such as nerve agents.

"This approval is a tremendous victory for children," stated AAP President Judith S. Palfrey, MD, FAAP. "As our nation observes the anniversary of the heinous attacks of September 11, 2001, it is fitting that our government has taken this step to protect our children from possible attacks or disasters. We commend the FDA for issuing this vital approval, which will give physicians and first responders a critical tool for treating children exposed to nerve agents."

"Pediatricians deeply appreciate the FDA's commitment to protecting children from terrorism and disasters," stated Steven Krug, MD, FAAP, Chairman of the Academy's Disaster Preparedness Advisory Council. "Pralidoxime is not a new drug; it has been used off-label in emergency departments to treat pesticide poisoning for many years, and its effectiveness is well-documented. The FDA's formal approval of this drug to treat nerve agent exposure will allow for the issuance of specific usage recommendations and dosing guidelines for children as well as stockpiling for disasters. The AAP and the National Commission on Children and Disasters brought this issue to the FDA's attention, and we are grateful for the agency's responsiveness."

Source:
American Academy of Pediatrics

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