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Botulinum Toxin Injections (Botox®): Safety
Side effects after BTX-A injection are generally related
to pain, tenderness, and bruising after injection as well
as to paresis of adjacent muscles, seen primarily with facial
and palmar treatment. [80,117,122]
Neurophysiological study of 37 patients treated for palmar
hyperhidrosis showed a decrease in compound muscle action
potential (CMAP) of several intrinsic hand muscles.[138]
The decrease of CMAP was noted 3 weeks after injection, ranged
from 36% to 64% compared to baseline, and returned to normal
by 37 weeks.[138]
The authors of this study conclude that even with careful
intradermal injection it is possible for BTX-A to diffuse
into adjacent intrinsic muscles; they recommend using Botox
doses no higher than 0.8 U per square centimeter in the skin
overlying the thenar and hypothenar eminence.[138]
Contraindications include infection in the injection site,
peripheral motor neuron disease (amyotrophic lateral sclerosis),
or neuromuscular junction disease (myasthenia gravis, Lambert-Eaton
disease), pregnancy, and lactation.[122]
There are several drugs known to interact with botulinum
toxins:
- Aminoquinolones
- Aminoglycosides
- Cyclosporine
- D-penicillamine
- Tubocurarine
- Pancuronium
- Gallamine
- Succinylcholine
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Some of these agents increase muscle weakness (aminoglycosides
and cyclosporine). Other drugs interfere with toxin effect
by inhibiting binding, intracellular transport, or lysosomal
processing of the botulinum toxin.[61,122]
A major concern about use of botulinum toxins is that development
of neutralizing antibodies will lessen the effectiveness of
repeat treatments.[122]
The only published study that addresses this question in the
treatment of hyperhidrosis is the 16-month open-label follow-up
study of 207 patients treated with BTX-A (Botox, 50 U per
axilla) for axillary sweating.[103]
Only 1 patient developed neutralizing antibodies to BTX-A.
However, this patient had a negative test for antibodies and
had a good clinical response to repeat BTX-A treatment after
the study was completed.
Further information regarding antibody formation in BTX-treated
patients is based on experience treating cervical dystonia
and facial spasm.[61]
The development of antibodies appears to be related to the
cumulative dose of BTX-A; frequency of injections and use
of booster injections are also a factor.[8]
Less than 5% of patients treated with BTX-A for various neurologic
problems develop neutralizing antibodies.[8,61]
In one study, 22% of patients treated with BTX-F at high doses
in order to achieve similar duration of action to that achieved
with the more-potent BTX-A were no longer responsive to the
toxin after 12 to 66 months.[8]
To decrease the risk for neutralizing antibody formation,
it is recommended that clinicians use the lowest effective
dose, intervals of at least 3 months, and no booster injections.[61]
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