FDA Approves Pediatric Use of Protopam for Organophosphate Poisoning

Martha Kerr

September 09, 2010

September 9, 2010 — The US Food and Drug Administration (FDA) has approved the pediatric use of pralidoxime chloride (Protopam Chloride; Baxter Healthcare), a drug used to treat poisoning by organophosphates, including neurotoxins. The drug can be administered to children either intravenously or intramuscularly.

"We know this drug has been widely used for many years to treat poisoning in pediatric patients in emergency situations," said Russell Katz, MD, director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research, in an agency release. "Improving the drug's label with new dosing information for children will give health care professionals better guidance on how to use this drug safely and effectively."

"It can be difficult to use [intravenous] drugs in children, particularly in emergency situations, so having the new option of [intramuscular] injection may help healthcare professionals use this medicine quickly and accurately," added Dianne Murphy, MD, director of the FDA's Office of Pediatric Therapeutics.

Pralidoxime chloride was approved by the FDA in 1964 to treat various types of pesticide and chemical poisoning in adults. The drug works as an antidote to organophosphate poisoning by inhibiting attachment of the chemical to neuroreceptors.

Organophosphates are used most often in pesticides by farmers and professional exterminators. Symptoms of poisoning include runny nose, teary eyes, blurred vision, double vision, dizziness, headache, drowsiness, vomiting, difficulty breathing, weakness, increased heart rate, increased blood pressure, and convulsions.

Immediate medical attention is indicated when chemical poisoning is suspected. More information is available on the MedLine Plus: Poisoning and the Poison Control Centers Web sites or by calling 800-222-1222.

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