New FDA Approvals
The U.S. Food and Drug Administration (FDA) recently approved the following drug:
Pyridostigmine bromide by the U.S. Army Medical Research and Materiel Command.
The FDA has approved pyridostigmine bromide to increase survival after Soman "nerve gas" poisoning, which causes loss of muscle control and death from respiratory failure. The product is approved for combat use by United States military personnel.
Pyridostigmine bromide is the first drug approved under an FDA rule that allows use of animal data for evidence of the drug’s effectiveness for certain conditions when the drug cannot be ethically or feasibly tested in humans. Evidence of the effectiveness of pyridostigmine bromide as a pretreatment for exposure to Soman was obtained primarily from studies in monkeys and guinea pigs.
A leaflet that explains the drug’s uses, benefits, and side effects will be provided to military personnel when the drug is distributed. The leaflet advises that pyridostigmine bromide should not be used by persons who have a history of bowel or bladder obstruction or sensitivity to certain medicines used during surgery (like physostigmine). Side effects that may occur include stomach cramps, diarrhea, nausea, frequent urination, headaches, dizziness, shortness of breath, worsening of peptic ulcer, blurred vision, and watery eyes.
The approved dose of pyridostigmine bromide for Soman pretreatment is one 30 mg tablet every 8 hours. The leaflet states that pyridostigmine should be started at least several hours before exposure to Soman and emphasizes that it must be discontinued upon exposure to nerve gas, at which point the antidotes atropine and pralidoxime are given.
The FDA has approved pyridostigmine bromide to increase survival after Soman nerve gas poisoning, which causes loss of muscle control and death from respiratory failure. The product is approved for combat use by United States military personnel.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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