Frequently Asked Questions about Botulinum Toxin

HOW DID BOTULINUM TOXIN COME TO BE USED AS A MEDICATION?

The idea that localized injections of small amounts of botulinum toxin may relieve medical disorders associated with involuntary activation of muscles was pioneered by Dr. Alan Scott in the early 1980's.  Dr. Scott found that by injecting tiny amounts directly into eye muscles, the symptoms of strabismus (lazy eye) could be improved.  He then proceeded to try the toxin in a condition called blepharospasm.  Blepharospasm is an involuntary spasm of the muscles around the eye such that the eyes blink excessively or become squeezed closed, sometimes rendering a person functionally blind.  Injections of botulinum toxin into these overactive muscles around the eye resulted in a relaxation of the muscles and an improvement of the symptoms, restoring almost normal function to many patients with this problem.  Subsequently, botulinum toxin was used to treat other disorders in which abnormal muscle activity was causing the symptoms.  Botulinum toxin was initially used in patients with spasmodic torticollis in 1984 and has subsequently been shown in many studies to be a safe and effective treatment. 
 

DOES BOTULINUM TOXIN TREATMENT CURE SPASMODIC TORTICOLLIS?

No.  The origin of spasmodic torticollis is believed to be located in the lower part of the brain, causing a message to be sent from the brain to the neck muscles telling them to contract.  The end result is that the muscles are abnormally activated causing the neck and head to turn.  Botulinum toxin, when injected into a muscle, interrupts this message, thus relaxing the overactive muscles and allowing the head and neck to be in a more normal position.  The underlying problem, however, has not been treated.  The effects of the toxin last about 3-4 months on average.  After that time, the message from the brain again reaches the neck muscles and the symptoms return.
 

HOW LONG DOES BOTULINUM TOXIN TAKE TO ACT AND WHAT IS THE LENGTH OF THE RELIEF?

The effect of the toxin usually begins in about three days after the injection.  There is a gradual relaxation of the injected muscles, usually reaching a peak 2-4 weeks after treatment.  The benefit remains fairly stable for about 2-3 months, at which time the effect gradually wears off and the symptoms slowly return.  Therefore, patients are usually re-injected every three to four months.
 

HOW MANY PATIENTS HAVE BEEN INJECTED AND HOW MANY BENEFIT?

Thousands of patients with spasmodic torticollis have received the botulinum toxin injections.  Approximately 75% to 85% obtain some relief of pain and improvement of head position.  The injections do not usually completely alleviate the symptoms, but provide for substantial improvement.
 

WHAT ARE THE SIDE EFFECTS FROM BOTULINUM TOXIN INJECTIONS?

At the time of injection, there may be pain or bruising from the needle inserted to inject the toxin.  In the first two weeks following injection, some patients have noticed new pain in the neck muscles.  This pain likely originates from the shrinkage of the injected muscles or from other muscles that may be trying to make up for the effects of the toxin.  Usually, using mild analgesics such as acetaminophen, cool compresses, and sometimes a soft collar will alleviate this pain.  The pain typically lasts from 1 to 3 weeks and then goes away.

Dysphagia (difficulty swallowing) has also been reported in up to 19% of the patients following botulinum toxin treatment and are likely due to the spread of small amounts of the toxin to the swallowing muscles.  The swallowing problem consists of a feeling that coarse solid foods, such as bread, chips, or steak, get caught in the throat and that one must swallow a few times, or drink water in order to clear the throat.  This side effect typically is mild, beginning 3 to 10 days following treatment and lasting from 1 to 3 weeks, although a few patients have had the symptoms for up to 6 weeks.  Avoiding large chunks of coarse solid foods during the time of the swallowing discomfort is the best course of action. If swallowing symptoms are more severe, contact your physician.

Sometimes, following the botulinum toxin injections, there can be some neck weakness.  This may be noticed when leaning forward or when rising out of bed. This weakness  is usually described as a heavy feeling of the head.  Usually, signs of weakness occur about two weeks following injection and last a variable amount of time, sometimes as long as a few weeks but then completely resolving.  If bothersome, wearing a soft neck collar can be of some help in relieving the symptom.
Another side effect reported in a very small number of patients include a temporary feeling of generalized tiredness or upper respiratory infection (such as a cold or flu, 12%)lasting a couple of days.

No patient has ever gotten botulism from these treatments because of the very small doses used.  If you have side effects that are not mild, you should notify your doctor.

WILL THE INJECTIONS BECOME LESS EFFECTIVE OVER TIME?

Repeated injections of botulinum toxin has caused resistance to the toxin in some patients. This means that after several treatments with good results, the injections may lose their effect. Fortunately, the development of resistance to botulinum toxin is unusual, affecting only a small number of people. It appears that frequent treatments (at intervals less than 3 months), routine use of “booster” injections and high doses of toxin predispose to the development of resistance. Limiting the dose of botulinum and the frequency of treatments is viewed as the best way to avoid development of resistance.  Some doctors check a blood test to see if the patient has developed an immunity to the toxin because of botulinum toxin antibodies, but accuracy of this test in identifying patients who are resistance is unproven, thus the usefulness of this test is unknown.  Sometimes, the doctor will perform a special test to check for botulinum toxin resistance.
Newer forms of botulinum toxin (botulinum toxin serotype B and F) have been studied in patients who have become resistant to the approved form of the toxin (type A).  Many patients who are resistant to type A will respond to type B.
 

DOES INSURANCE OR MEDICARE COVER THE COST OF THE BOTULINUM TOXIN INJECTIONS?

Medicare has approved the botulinum toxin injections for spasmodic torticollis.  If you have private insurance or an HMO, you should check with your insurance company regarding coverage.  If you have problems with your insurance, the Allergan BOTOX Reimbursement Hotline and Patient Assistance Program may be able to help:  1-800-530-6680.