Botulism Antitoxin

Botulism antitoxin is used intravenously as a treatment for those infected with bacterium Clostridium botulinum.

Overview:

Patients become infected with botulism when they become infected with the bacterium Clostridium botulinum, which produces the toxin responsible for botulism. The toxin targets nerves and weakens muscles, forcing the patient to progressively become weaker and weaker until they can no longer open their eyes, speak, or even breathe.

Botulism is treated with an antitoxin that will protect the patient's nerves from the botulinum toxin. The antitoxin is not a cure and will not be able to reverse the damage that has already been done to nerves. Given time and supportive therapy, however, the nerves may begin to heal on their own.

The botulism antitoxin was developed from antibodies in human blood plasma and was approved by the FDA in 2003. In 2013 the FDA approved a military developed antitoxin that was developed from equine plasma. The antitoxin developed from equine plasma, known as a heptavalent antitoxin, is effective against all known strains of botulism, while the antitoxin developed from human plasma (known as trivalent) is usually only known to treat the A, B, and E strains of botulism. In all cases, the botulism antitoxin is delivered intravenously over the course of several hours. Patients who have been diagnosed with botulism should begin receiving injections of the botulism antitoxin as soon as possible. When treated, botulism has a mere 7.5% risk of fatality. When allowed to progress untreated, botulism kills at a rate between 40 and 50%.

The botulism antitoxin is manufactured by Cangene Corporation and is available in solution form. The heptavalent botulism antitoxin, which is derived from equine plasma, was developed primarily with money from the U.S. military. The U.S. government maintains a stockpile of the botulism antitoxin as a safety measure against possible bioterrorist attacks.

Conditions Treated:

  • Botulism
  • Botulism prophylaxis

Type of Medicine:

  • Antitoxin

Side Effects:

Injections of the botulism antitoxin can produce a range of unwelcome effects on the patient. If the patient begins to experience any of the following side effects after beginning to receive injections of the botulism antitoxin they should notify their doctor immediately. The following side effects require medical attention:

  • Headache
  • Hives
  • Itching
  • Rash
  • Reddened skin
  • Nausea
  • Chills
  • Fever
  • Unusual or uncomfortable sensations in the throat
  • Chest pain
  • Coughing
  • Difficult or noisy breathing
  • Rapid or irregular heartbeat
  • General discomfort
  • Sweating
  • Inflamed joints
  • Lightheadedness
  • Fainting
  • Muscle aches
  • Lack of blood pressure/pulse
  • Stopped heart
  • Swollen lymph glands
  • Tightness in chests
  • Unconsciousness
  • Unusual tiredness

The following side effects have been reported by patients, but as of yet the incidence remains unknown. Patients who experience the following side effects should contact their doctor immediately, as they require medical attention.

  • Blurred vision
  • General confusion
  • Difficulty moving or swallowing
  • Sudden lightheadedness when rising from a prone or seated position
  • Hoarseness
  • Massive swelling of the hands, feet, eyelids, lips, tongue, throat, or groin
  • Muscular pain, cramps, or stiffness
  • Puffiness of the face
  • Redness of the skin
  • Swollen or painful sweating

Not all side effects necessarily demand medical attention. Injections of the botulism antitoxin can be taxing on a patient’s body and can take some time for the body to adjust to. Patients who experience the following side effects should report them to their doctor and seek advice on how to prevent or reduce them.

  • Anxiety
  • Irregular urination habits
  • Difficulty urinating
  • Dry mouth
  • Hyperventilation
  • Irritability
  • Restlessness
  • Shaking
  • insomnia

This is not necessarily a complete list of side effects. Patients should contact their doctor immediately if they begin to experience new or unexpected symptoms after beginning to receive injections of the botulism antitoxin. New side effects can be reported to the FDA at 1 800 FDA 1088 or at www.fda.gov/medwatch.

Dosage:

The botulism antitoxin is administered intravenously under the supervision of trained medical professionals. Patients should begin to receive injections of the botulism antitoxin as soon as they receive their botulism diagnosis. When left untreated, botulism has a mortality rate between 40 and 50%. The botulism antitoxin is diluted into a solution of .9% sodium chloride so that the ratio of botulism antitoxin to sodium chloride solution is 1:10.

The rate of injection of the botulism antitoxin will vary based on several factors, including the patient’s age, weight, body composition, and tolerance. In infants and children the injection is usually begun at a rate of .01 milligrams per kilogram a minute for at least the first half hour. In infants and children the standard maximum injection rate sits at around 0.03 milligrams per kilogram per minute.

In adults the standard injection rates are higher than those typically used in children and infants. The standard adult beginning injection rate is around 0.5 ml a minute for the first half hour. If the patient can tolerate the dose then it is usually increased every thirty minutes to as much as 2ml per minute.

The total amount injected is usually measured by vial. Adults typically receive a full single use vial while children usually receive a percentage (minimum 20%) of the vial depending on their weight. Vials come in 20 milliliter and 50 milliliter volumes.

Interactions:

Patients who are going to receive injections of the botulism antitoxin should disclose the full list of medications, drugs, and supplements they are taking to their doctor prior to receiving injections of the botulism antitoxin. Drugs can interact with each other in unique ways, possibly increasing or decreasing the effects of one another, raising the risk of side effects, or producing a whole new effect.

The botulism antitoxin can interfere with blood glucose monitoring systems. Patients who are using a blood glucose monitoring system at the time they receive injections of the botulism antitoxin should be aware that the readings will be artificially changed as a result of the infection. Patients should consult their doctor as to the best way to proceed with respect to the altered readings and how best to use that information to inform insulin administration and hypoglycemia treatment.

The botulism antitoxin may interact with a patient’s preexisting medical conditions. Patients should disclose a full list of the medical conditions they are living with, including recurrent diseases, viruses, and allergies.

This is not necessarily a complete list of interactions. Patients should disclose a full list of medications, drugs, and supplements they are taking to their doctor prior to receiving injections of the botulism antitoxin.

Warnings:

The botulism antitoxin has been known to cause severe allergic reactions. Patients should be monitored for signs of allergic reaction, such as hives, swelling of the face or throat, difficulty breathing, or anaphylaxis.

Allergic reactions have been known to be delayed for as long as several weeks, resulting in a condition known as serum sickness, which can cause symptoms including rashes, fever, and hives. Some studies have shown that the risk of serum sickness is greatly increased in infants who receive the heptavalent form of the botulism antitoxin. Other studies have contradicted these findings.

Some forms of the botulism antitoxin are derived from equine plasma. Patients who are allergic to horses or various equine products should avoid receiving any botulism antitoxin which was derived from equine plasma.

The botulism antitoxin is a Class C drug for pregnancy. Testing in animals has consistently shown damage to the fetus, but insufficient testing has been done on humans to determine whether or not the botulism toxin can be damaging to human fetuses. Patients who are pregnant or breastfeeding should exercise caution when deciding whether or not to receive injections of the botulism antitoxin and weigh the risks and benefits of it. Patients who are making this decision should keep in mind that when left untreated botulism has a mortality rate of between 40 and 50%.

The botulism antitoxin has not been properly evaluated in pediatric or geriatric populations. Among the handful of pediatric patients treated with the antitoxin, a disproportionately high number (<10%) have reported an adverse reaction to the treatment.

Individuals with asthma, hay fever, or seasonal allergies should use caution when deciding to receive injections of the botulism antitoxin. These conditions may cause complications, including increased risk of recurrent allergic reaction.

In every iteration of the botulism antitoxin, it is derived from organic plasma: human or equine. As such, there is some risk that bacteria or viruses from the plasma will remain in the antitoxin, despite efforts to screen and treat the plasma. Patients who begin to experience new or heightened symptoms after receiving an injection of the botulism antitoxin should contact their doctor immediately.

As of 2013 there were no known cases of a patient contracting a disease that was transmitted by injections of the botulism antitoxin. No diseases have been identified as being more at risk of being transmitted through injections of the botulism antitoxin.

Storage:

Botulism antitoxin should only ever be stored and administered by trained medical professionals. In nearly every case, the patient should not have to worry about the proper storage of the botulism antitoxin.

The botulism antitoxin should be stored frozen, at or below 5 degrees Fahrenheit, until it is used.

Vials of the botulism antitoxin which have been thawed can be stored for as long as 36 months at a temperature between 36 and 46 degrees Fahrenheit. Vials which have been thawed should never be refrozen.

Once a vial of the botulism antitoxin has been punctured it should be administered as quickly as possible. In the event that a full vial is not used during the course of the treatment, the remaining botulism antitoxin must be discarded.

Summary:

The purpose of the botulism antitoxin is simple: to treat botulism. Patients who have become infected with botulism are faced with little option but to temper their infection with injections of the botulism antitoxin. Left untreated, botulism kills at a rate between 40 and 50%. In most cases, the threat of botulism outweighs any and all risks that accompany injections of the botulism antitoxin. The administration of the botulism antitoxin is largely the responsibility of medical professionals, leaving little for the patient to do but be a willing receiver of the treatment. Patients should seek out the highest quality medical care they can in order to reduce the risks of complications or unaddressed adverse reactions.