Questions
and Answers on
Pyridostigmine Bromide
- What is the Food and Drug
Administration (FDA) announcing?
- What is the basis for the
approval of pyridostigmine bromide?
- Why does FDA think
pyridostigmine bromide will work in humans if it was only tested in
animals?
- What is Soman?
- Has pyridostigmine bromide
ever been approved for another use?
- How does pyridostigmine
bromide work against Soman?
- Can be given after
exposure to Soman?
- What are possible side
effects of pyridostigmine bromide?
- Are there any long-term
side effects of pyridostigmine bromide?
- Who should not take pyridostigmine
bromide?
- Was pyridostigmine
bromide used in the Gulf War?
- How is pyridostigmine
bromide taken?
- Can people who are not in
the military get pyridostigmine bromide for themselves and their
families?
1. What is the Food and
Drug Administration (FDA) announcing?
FDA is announcing the approval of
pyridostigmine bromide to increase survival after exposure to the nerve
agent Soman. Pyridostigmine bromide is approved only for combat use by
U.S. military personnel.
2. What is the basis
for the approval of pyridostigmine
bromide?
Pyridostigmine bromide was approved under
a FDA rule
that allows the agency to rely on animal study data as evidence of
effectiveness when studies in humans are not possible. Normally, FDA
regulations require studies to be performed in humans but, because
exposing humans to nerve agents is too dangerous, effectiveness studies in
animals are considered acceptable in such circumstances. The safety data
on the use of this product was obtained from humans who took
pyridostigmine bromide.
3. Why does FDA think pyridostigmine
bromide will work in humans if
it was only tested in animals?
FDA believes, based on what it knows about
the animals studied, that it is reasonably likely that humans will respond
similarly. Primarily in studies with monkeys and guinea pigs,
pyridostigmine bromide was shown to be effective in protecting against
Soman's deadly effects.
4. What is Soman?
Soman is a nerve agent that blocks an
enzyme muscles need to work properly. Soman exposure can cause loss of
muscle control and death if the muscles required for breathing are
paralyzed.
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5. Has pyridostigmine
bromide ever been approved for
another use?
Yes, pyridostigmine bromide was first
approved in 1955 to treat myasthenia gravis, a chronic muscle disease.
6. How
does pyridostigmine bromide
work against Soman?
Pyridostigmine bromide appears to work by
preventing Soman from blocking an enzyme that muscles need to work
properly. Pyridostigmine bromide must be taken before exposure to Soman.
Pyridostigmine bromide alone will not protect against Soman poisoning.
However, nerve agent antidotes (atropine and pralidoxime) work better
against Soman if pyridostigmine bromide is taken before exposure to Soman.
7. Can pyridostigmine
bromide be given after exposure to Soman?
No. Military personnel will be told that
pyridostigmine bromide is not expected to be effective if taken after
exposure to Soman. Military personnel will also be advised that taking
pyridostigmine bromide after exposure to Soman can make the harmful
effects of Soman exposure worse.
8. What are possible
side effects of pyridostigmine bromide?
Some side effects that may occur include:
- stomach cramps
- gas
- diarrhea
- nausea
- increased urge to urinate
- drooling
- sweating
- headaches
- dizziness
- eye tearing
- blurred vision
- runny nose
- shortness of breath
- acid stomach, including heartburn or
reflux
- tingling of fingers, toes, arms, and
legs
- muscle twitching, weakness, or cramping
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9. Are there any
long-term side effects of pyridostigmine
bromide?
Pyridostigmine bromide was first approved
in 1955, and has been prescribed by doctors to treat patients with
myasthenia gravis for over 40 years. To date, no long-term health problems
thought to be associated with pyridostigmine bromide have been
reported by these patients.
10. Who should not
take pyridostigmine bromide?
Pyridostigmine bromide should not be taken
by military personnel who:
- have a history of bowel or bladder
blockage
- have sensitivity to certain medicines
used during surgery (like physostigmine, edrophonium, neostigmine, and
ambenonium).
Military personnel should tell their
doctor or medic before taking pyridostigmine bromide if they:
- take medications for glaucoma or blood
pressure
- have asthma
- are pregnant
- are allergic to bromide.
11. Was pyridostigmine
bromide used in the Gulf War?
Yes. At the time of the Gulf War, pyridostigmine
bromide was not approved to prevent death from exposure to a nerve agent.
However, during that time, FDA allowed the military to distribute pyridostigmine
bromide as an investigational new drug for that use. Today's action
provides FDA approval for military combat use of pyridostigmine bromide to
prevent death from exposure to Soman.
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12. How is pyridostigmine
bromide taken?
The approved dose of pyridostigmine
bromide is one 30-mg. tablet every 8 hours
to be started at least several hours
prior to Soman exposure. Pyridostigmine bromide is taken within 8 hours
before, but not right before, exposure to nerve agent. (If pyridostigmine
bromide is taken right before (when the nerve gas attack alarm is given)
or during nerve agent exposure, it may not work and may make the effects
of Soman worse.) The patient information sheet that accompanies the
medication emphasizes that at the first sign of nerve agent poisoning
military personnel should not take any more pyridostigmine bromide and
should immediately take the nerve agent antidotes (atropine and pralidoxime).
13. Can people who are
not in the military get pyridostigmine
bromide for themselves and
their families?
No. Pyridostigmine bromide is only
approved for use in military combat situations, therefore pyridostigmine
bromide is only available to military personnel.
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Pyridostigmine Bromide Information
FDA/Center for Drug Evaluation and Research
Last Updated: February 5, 2003
Originator: OTCOM/DLIS
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