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Complications associated with the use of Botox in the management of facial dystonia
Complications associated with the use of Botox can be reduced by skillful use of the medication.
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Botulinum toxin (Botox; Allergan) has revolutionized the treatment of patients who have blepharospasm, hemifacial spasm and Meige’s syndrome. Prior to its use, the majority of patients with these problems who sought treatment underwent extensive surgical procedures, including partial 7th nerve resection and extensive dissection of the orbicularis and related facial muscles.
There still are some patients who become refractory to the injection of Botox and, in these patients, surgical correction still is indicated. The majority of patients, however, do respond to periodic injections. The interval between the injections is somewhat variable according to the patient, usually every three to four months, but longer in a limited number of patients.
David B. Soll, MD
Botulinum A toxin is a safe medicine that has been used on more than 100,000 patients for nearly 20 years. It is the treatment of choice in the management of benign essential blepharospasm, hemifacial spasm and Meige’s syndrome.
Complications associated with the use of Botox can be reduced by skillful use of the medication. This includes proper reconstitution of the medication, handling of the medicine, storage of the medicine and its injection.
Store frozen
---Patient with classic, untreated, benign, essential blepharospasm.
If the medication is improperly reconstituted, improperly mixed or improperly stored, then the strength at the time of injection will be reduced and the patient will have the complication of inadequate control. It is imperative that the medicine be stored frozen.
It also is imperative that the medicine be reconstituted with preservative-free saline. When reconstitution takes place, the saline should flow slowly into the vial, rather than splashing violently against the freeze-dried toxin in the base of the vial. Getting the medicine into solution should occur by gentle rolling of the vial, rather than aggressive agitation, because the toxin is very fragile. Strict adherence to these principles is vitally important or the patient will be injected with less than full strength medication.
Complications
Blepharoptosis is the most common complication of injection of the medicine. It is reported to occur in 10% of patients after upper lid injection. It may be mild, moderate or severe in amount, will have its onset 2 to 10 days after the injection of the medication and is fortunately self-limited, usually clearing in 3 to 6 weeks. It is caused by absorption of Botox by the levator muscle. The incidence of this complication can be reduced by placing the medication 2 mm to 3 mm superior to the upper punctum in the subcutaneous plane and 10 mm lateral to the lateral canthal angle and slightly above it.
Some patients are significantly more susceptible to this complication. These patients may have an abnormal orbital septum, which allows unusual penetration of the medicine into the levator. If a patient is unusually susceptible, then the dose of medication should be reduced and/or should be placed at a site more lateral to the lateral canthus.
Paralytic ectropion will occur in patients who have their lower lid injected, if they have pre-injection horizontal laxity and impending involutional ectropion. This complication can be avoided by recognition of impending involutional ectropion and/or more inferior lateral placement of injections in the lower lid. If injection of the lower lid is required, and marked horizontal laxity is present, then surgical correction of the involutional ectropion should be carried out prior to injection.
Vertical diplopia is infrequently seen in patients receiving Botox injections. It is caused by paresis in the inferior oblique muscle and is directly related to injection too close to the origin of the muscle at the infraorbital rim. Some individuals are markedly more susceptible to this complication also. The incidence can be reduced by avoiding injection of the medial one-third of the lower lid and keeping the medication in a superficial subcutaneous plane.
A small number of patients will re port drooling and/or biting of the inside of their mouth for a period of time after injection. This is an indication that excessive medication has been placed in the area of the cheek, nasal labial fold and/or the corner of the mouth. This complication also is self-limited.
Ecchymosis
Ecchymosis may occur after the injection of Botox, just as it may occur after any other injection. The groups of patients receiving this medicine usually are elderly and many are partially anticoagulated with aspirin, nonsteroidal anti-inflammatory medications and/or Coumadin (warfarin sodium; DuPont). If a patient is particularly susceptible to ecchymosis, then immediate pressure should be placed at the site of injection by the physician’s assistant, and in extreme cases, it may be appropriate for the patient to use ice compresses immediately after their injections.
The majority of patients accept the mild pain associated with injection of the medication, particularly if a 30-gauge needle is used and the medication is injected slowly. The pain also can be decreased slightly if the medication is allowed to warm slightly prior to injection. Patients who require Botox and have previously undergone either limited or complete myomectomy will have significantly greater discomfort if the medication is injected in their prior surgical site. This intolerance may be significantly reduced by the application of Emla cream (lidocaine and prilocaine; Astra) 30 minutes before injection.
Systemic toxicity is not a realistic complication of Botox injections in the usual doses used. It is extremely rare for a patient with facial dystonia to receive more than 200 units. The known human LD50 for this medication is 3,000 units.
As with all medical procedures, attention to detail will markedly reduce complications. This is certainly true for botulinum A toxin.
For Your Information:
- John A. Burns, MD, can be reached at 340 E. Town St., Ste. 8-200, Columbus, OH 43215-4619; (614) 221-7464; fax: (614) 221-8117. Dr. Burns has no direct financial interest in any of the products mentioned in this article, nor is he a paid consultant for any companies mentioned.