Distant Spread of Toxin Effect
Postmarketing reports indicate that the effects of DYSPORT™ and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms. In unapproved uses, including spasticity in children and adults, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and at lower doses.
|
| |
DYSPORT SUMMARY
Botulinum toxin type A, the active ingredient in DYSPORT™ (abobotulinumtoxinA), is a purified neurotoxin type A complex produced by fermentation of the bacterium Clostridium botulinum type A, Hall Strain.
Cervical Dystonia
DYSPORT™ (abobotulinumtoxinA) is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for the treatment of adults with cervical dystonia to reduce the severity of abnormal head position and neck pain in both toxin-naive and previously treated patients.
Glabellar Lines
DYSPORT™ (abobotulinumtoxinA) is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with procerus and corrugator muscle activity in adult patients <65 years of age.
|
|
NEWS HIGHLIGHTS
Published Studies Related to Dysport (Botulinum Toxin Type A)
A Prospective, Split-Face, Randomized, Double-Blind Study Comparing
OnabotulinumtoxinA to IncobotulinumtoxinA for Upper Face Wrinkles. [2015]
wrinkles using a 1:1 dose ratio... CONCLUSIONS: For identical dosage, both onabotulinumtoxinA and
The efficacy and safety of liquid-type botulinum toxin type A for the management
of moderate to severe glabellar frown lines. [2015]
lines... CONCLUSIONS: The efficacy and safety of MT10109L were comparable to those of
The early use of botulinum toxin in post-stroke spasticity: study protocol for a
randomised controlled trial. [2014]
BACKGROUND: Patients surviving stroke but who have significant impairment of
function in the affected arm are at more risk of developing pain, stiffness and
contractures. The abnormal muscle activity, associated with post-stroke
spasticity, is thought to be causally associated with the development of these
complications...
Correlation of botulinum toxin dose with neurophysiological parameters of
efficacy and safety in the glabellar muscles: a double-blind, placebo-controlled,
randomized study. [2014]
Despite the extensive use of botulinum toxin type A (BoNT-A) in treatments for
glabellar frown lines, the dose-response effect in the glabellar muscles remains
unknown. The aim of this randomized, double-blind, placebo-controlled prospective
study was to characterize the neurophysiological parameters that correlate with
the effect of BoNT-A in the glabellar muscles and its diffusion to surrounding
ocular muscles...
Botulinum toxin type A potentiates the effect of neuromotor rehabilitation of
Pisa syndrome in Parkinson disease: a placebo controlled study. [2014]
group of PD patients with PS... CONCLUSIONS: Our preliminary data suggest that BT may be considered an important
Clinical Trials Related to Dysport (Botulinum Toxin Type A)
Onabotulinum Toxin Type A and Abobotulinum Toxin Type A Crow's Feet Rhytid Study [Completed]
The objective of the study is to compare the time to onset of Dysport® versus Botox® in the
treatment of lateral orbital rhytids ("crow's feet"). Thirty subjects were enrolled in the
study; specifically 30 male or female patients 18 years or older with moderate to severe
lateral orbital rhytids at maximum contracture. Each patient were randomized to be treated
with Dysport® on one side and Botox® on the other side. Both the injector and patient were
blinded to the injected toxin.
The efficacy endpoints were determined by investigator and subject live assessment of
"crow's feet" at rest and maximum contraction at each visit (every other day for 6 days
post-injection, every month for 9 months following) using a validated 5 point photographic
scale(no wrinkles [0], very fine wrinkles [1], fine wrinkles [2], moderate wrinkles [3] or
severe wrinkles [4]) used in previous studies. A written description of each photograph was
included to help standardize the application of the Photographic Scale.
A Study to Compare Dysport� and Botox� in the Treatment of Cervical Dystonia [Completed]
1. to examine the non-inferiority of Dysport in the clinical efficacy and safety in
comparison with Botox®, assuming a bioequivalence ratio of 2. 5: 1 units, in the
treatment of Cervical dystonia.
2. double blind, randomised, multi center, crossover study
Dysport for the Treatment of OMD [Recruiting]
The purpose of this study is to study the efficacy, safety, and proper dosing of
AbobotulinumtoxinA (Dysport) for use in Oromandibular Dystonia (OMD). The study hypothesis
is that one of the dosing levels used will have adequate safety and efficacy.
Dysport in the Treatment of Glabellar Lines in Chinese Subjects [Recruiting]
The Value of Botox-A for Management of Low Anterior Resection Syndrome [Active, not recruiting]
Low anterior resection syndrome (LARS) is frequent after treatment for low rectal cancer.
Increased bowel frequency and urgency with rectal spasms and incontinence have deleterious
impacts on quality of life in a third of the cases.
One possible physiopathology hypothesis suggests an ongoing spastic process; different
mechanisms have been postulated. These include alteration of normal anorectal sensation
with loss of the recto-anal inhibitory reflex (RAIR), decreased rectal compliance and
reduced rectal capacity as well as sphincter damage secondary to preoperative chemoradiation
therapy or during surgery.
Current available treatments are often ineffective, highlighting the need for more
successful management. Botulinum toxin A (BTX-A) is a neurotoxin inhibiting acetylcholine
release at the neuromuscular junction. It is currently used for the treatment of various
smooth muscle spastic diseases.
The hypothesis of this study is that intra-rectal BTX-A injections could represent a medical
treatment alternative for LARS. The goal of this study is to document the effects of
intra-rectal BTX-A injections on sphincter function and quality of life of patients with
LARS.
Reports of Suspected Dysport (Botulinum Toxin Type A) Side Effects
Dysphagia (18),
Muscular Weakness (17),
Neck Pain (12),
Wrong Technique in Drug Usage Process (10),
Drug Ineffective (10),
Headache (8),
Eyelid Ptosis (8),
Asthenia (8),
Fall (7),
Diplopia (7), more >>
|
PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 2 ratings/reviews, Dysport has an overall score of 5. The effectiveness score is 5 and the side effect score is 7. The scores are on ten point scale: 10 - best, 1 - worst.
| | Dysport review by 43 year old female patient | | | Rating |
| Overall rating: | |   |
| Effectiveness: | | Moderately Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | wrinkles |
| Dosage & duration: | | 300 units (dosage frequency: one time treatment) for the period of one time treatment |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | I had deepening frown lines on my forehead and between my eyes....the benefits were a decrease of the lines (wrinkles). |
| Side effects: | | I had a mild headache for a couple of days after my injections. Also, my forehead felt "numb" as if I had had a tooth pulled. Now, when I raise my eyebrows, my eyebrows go up and the middle of my forehead stays still. It looks a bit strange. |
| Comments: | | I had 300 units of Dysport injected into my forehead in about 5 different places. I was told to not bend over or lie back for a few hours or touch my forehead after the treatment. I followed my doctors instructions. It has been over a week since the injections and there is still a mild wrinkle between my eyes. The wrinkle is definitely not as deep looking as it was but it is still visible. I would probably have this done again although the results are not perfect.
|
|
| | Dysport review by 58 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Marginally Effective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | brow wrinkles |
| Dosage & duration: | | 1-2 viles (dosage frequency: twice) for the period of 4-6 injections each time |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | There was a slight softening of the verticle wrinkles between my eyebrows, or "11" lines, but not the degree of change I was looking for, or had been suggested was possible by my physician, even after the second treatment. |
| Side effects: | | I had severe black eyes and brusing after first round of injections and loss of the eye lid crease in my left eye. The bruising took two weeks to completely clear and the lost lid crease never completely returned to normal so is being monitored by my physician and the manufacturer of the Dysport since this was an unusual outcome. |
| Comments: | | Injections were adminsitered by a board certified opthamologist and plastic surgeon who has specal training with this product and instructs other physiians in its use. She couldnot explain my poor outcome other than to say I had very reisistant muscles and the furrowing was very deep. |
|
|
|
Page last updated: 2015-08-10
|
