Name: BAT

Uses for BAT

Treatment of Botulism

Treatment of symptomatic botulism following documented or suspected exposure to botulinum neurotoxin serotypes A, B, C, D, E, F, or G;1 9 12 70 105 designated an orphan drug by FDA for treatment of botulism.2

Botulism is a potentially fatal neuroparalytic illness characterized by acute afebrile, symmetric, descending, flaccid paralysis.5 8 9 12 70 105 Caused by neurotoxin produced by Clostridium botulinum;5 8 9 10 12 70 105 certain strains of C. argentinense, C. baratii, and C. butyricum also can produce neurotoxin and cause botulism.9 10 12 70 105 C. botulinum spores are ubiquitous in the environment in soil and water sediments and can germinate into the vegetative bacteria that produce toxin.9 12 70 105 There are 7 known serotypes of botulinum toxin (A, B, C, D, E, F, G) and all cause similar disease;5 8 9 10 12 70 105 naturally occurring human botulism usually involves serotypes A, B, E, and F.5 8 9 10 12 70 105

Foodborne botulism occurs following ingestion of food contaminated with botulinum toxin (e.g., improperly canned food);5 8 9 10 105 symptoms usually begin 12–48 hours (range: 2 hours to 10 days) after ingestion.5 10 70 105 Wound botulism occurs following contamination of wounds with C. botulinum spores from the environment that then germinate and produce botulinum toxin;5 8 9 10 105 time between wound contamination and onset of symptoms usually is 4–14 days.105 Infant botulism occurs when infants <1 year of age ingest C. botulinum spores that then germinate, colonize the GI tract, and produce botulinum toxin;5 8 9 10 105 time between exposure and onset of symptoms estimated to be 3–30 days.105 Intestinal botulism (child or adult) occurs following intestinal colonization with C. botulinum and subsequent production of botulinum toxin.5 8 10

Botulism also could potentially occur from iatrogenic overdose or misinjection of commercially available botulinum toxin used therapeutically (e.g., abobotulinumtoxinA, incobotulinumtoxinA, onabotulinumtoxinA, rimabotulinumtoxinB) or from inhalation of aerosolized botulinum toxin (e.g., in the context of biologic warfare or bioterrorism).8 9 10 12 70 105 Symptoms of botulism may be evident within 12–72 hours following an inhalation exposure.12 70

For the Consumer

Applies to botulism antitoxin: intravenous solution

Along with its needed effects, botulism antitoxin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking botulism antitoxin:

More common
  • Headache
  • hives or welts
  • itching skin
  • nausea
  • rash
  • redness of the skin
Less common
  • Chills
  • fever
  • throat discomfort
  • Chest pain or discomfort
  • cough
  • difficulty with breathing
  • fast, pounding, or irregular heartbeat or pulse
  • feeling of discomfort
  • increased sweating
  • inflammation of the joints
  • lightheadedness, dizziness, or fainting
  • muscle aches
  • no blood pressure or pulse
  • noisy breathing
  • slow or irregular heartbeat
  • stopping of heart
  • swollen lymph glands
  • tightness in the chest
  • unconsciousness
  • unusual tiredness
Incidence not known
  • Blurred vision
  • confusion
  • difficulty with moving
  • difficulty with swallowing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • hoarseness
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • muscle cramping
  • muscle pains or stiffness
  • noisy breathing
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • redness of the skin
  • sweating
  • swollen joints
  • swollen, painful, or tender lymph glands in the neck, armpit, or groin

Some side effects of botulism antitoxin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

  • Anxiety
  • decrease in the frequency of urination
  • decrease in urine volume
  • difficulty in passing urine (dribbling)
  • dry mouth
  • hyperventilation
  • irritability
  • painful urination
  • restlessness
  • shaking
  • trouble sleeping
Incidence not known
  • Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site