“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 at the FDA’s Center for Drug Evaluation and Research, in a prepared statement. “Improving the drug’s label with new dosing information for children will give healthcare professionals better guidance on how to use the drug safely and effectively.”
Patients commonly interact with organophosphate pesticides and chemicals, the nerve agents the drug treats, in farm and exterminator settings. The agents may cause symptoms as mild as runny nose, teary eyes, and vomiting, to those as serious as difficulty breathing, weakness, and convulsions.
Pralidoxime was initially approved in 1964 to treat adult pesticide and chemical poisoning.
Adverse events for pediatric and adult patients treated with pralidoxime include blurred vision, double vision, dizziness, headache, drowsiness, nausea, difficulty breathing, increased heart rate, and increased blood pressure.
The drug can be administered through an intravenous or intramuscular injection.