A:
During Operation Desert Storm, the threat of use of nerve agents by Iraq was very high. After careful deliberation by a specially constituted human-use review committee of the Food and Drug Administration, it was determined that the pretreatment could help save the lives of many Service members if nerve agents were used. Approval for the use of pyridostigmine bromide was based on extensive scientific information that supported the safety and effectiveness of pyridostigmine bromide as a preventive treatment.
Pyridostigmine bromide is not an exotic or experimental drug. The Food and Drug Administration approved it in 1955 for use in treating myasthenia gravis, a neuromuscular disease that causes muscle weakness and fatigue. However, when approved for use in the Gulf, the approval was as an investigational new drug. This classification means that pyridostigmine bromide had not been formally approved for general commercial marketing as a nerve gas antidote.
There was no effort to withhold information from the troops or the public. In fact, pyridostigmine bromide use was widely reported by the news media at the time. The Department of Defense believes that most individuals knew they were taking an oral drug to counter the effects of a possible attack with nerve agents. However, troops did not receive enough information about the possible side effects of pyridostigmine bromide. Information was prepared for distribution in the field, but it did not arrive before hostilities began.
The Defense Department estimates that approximately 250,000 personnel took at least some pyridostigmine bromide during the 1990-1991 Gulf War. During the 1990-1991 Gulf War, all U.S. troops were to have received packets containing pyridostigmine bromide pills.
Actual administration of the pre-treatment was decentralized in nuclear, biological chemical (NBC) and not medical channels. It was intended to be self-administered upon a unit commander's order. We know that in some units, pyridostigmine bromide administration was carefully monitored, while in others, it was not. However, accurate assessments of actual pyridostigmine bromide use are difficult because no specific records were kept of self-administered medications.
To date, the Food and Drug Administration has recalled none of the drugs or vaccines administered by the military. If you would like more information on pyridostigmine bromide you may contact the Defense Personnel Support Center at (215) 737-5768.