FDA Approves Military Use of Anti-Nerve Gas Medication

The Food and Drug Administration on Wednesday approved a drug that is intended to increase the chance of survival for people exposed to the nerve gas soman. The drug is limited to use by U.S. military personnel.

The agency said it has approved the use of pyridostigmine bromide under a special rule that allows animal data for proof of a drug’s effectiveness when the drug can’t be ethically or feasibly tested in humans.

“Today’s action will help protect American troops and others from nerve agent attacks,” said FDA Commissioner Mark B. McClellan.

Experimental use of the drug during the Persian Gulf War was blamed by some soldiers for illnesses suffered after they returned home, and a study by the Rand research group concluded that the drug “cannot be excluded as a contributor to illness” in Gulf War veterans.

The nerve agent soman causes loss of muscle control and death from respiratory failure.

In tests on monkeys and guinea pigs, the use of pyridostigmine bromide before exposure to soman, together with atropine and pralidoxime given after exposure, increased survival rates.

Based on this, the FDA said it believes that pyridostigmine bromide is also likely to be a benefit to humans exposed to soman. Military personnel must carefully follow instructions and use the drug only under specific circumstances.

The drug is not effective if taken at the time of, or after, exposure to the nerve gas, the agency said. Side effects may include stomach cramps, diarrhea, nausea, headaches, dizziness, shortness of breath and watery eyes, the FDA said.

The drug was first approved by the agency in 1955 to treat a neuromuscular disease called myasthenia gravis.