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.
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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.
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NEWS HIGHLIGHTS
Published Studies Related to Dysport (Botulinum Toxin Type A)
Botulinum toxin injection for hypertonicity of the upper extremity within 12
weeks after stroke: a randomized controlled trial. [2012]
BACKGROUND: Botulinum neurotoxin type A (BoNT-A) reduces upper-extremity
poststroke spasticity when given 6 or more months after stroke... Functional use of the arm and hand was not
affected.
Immunoresistance in cervical dystonia patients after treatment with
abobotulinumtoxinA. [2012]
Formation of antibodies against botulinum toxin type A has been observed
following treatment of Cervical Dystonia (CD). We present the immunological
findings from two 12-week Phase III prospective, randomized, double-blind,
single-dose, placebo-controlled studies (Study 1, n = 116; Study 2, n = 136)...
Prospective randomized comparison of onabotulinumtoxinA (Botox) and
abobotulinumtoxinA (Dysport) in the treatment of forehead, glabellar, and
periorbital wrinkles. [2012]
California) and abobotulinumtoxinA (BoNT-ABO; Dysport, Ipsen Ltd, Slough, UK)... CONCLUSIONS: At the current pricing of the agents, BoNT-ABO offers a significant
Effectiveness of type A botulinum toxins for aesthetic indications and their
relative economic impact. [2012]
BoNT-A formulations licensed for aesthetic indications in the UK... CONCLUSION: In most scenarios, BoNT-A treatment with abobotulinumtoxinA will
Anticholinergic therapy vs. onabotulinumtoxina for urgency urinary incontinence. [2012]
therapy are needed... CONCLUSIONS: Oral anticholinergic therapy and onabotulinumtoxinA by injection
Clinical Trials Related to Dysport (Botulinum Toxin Type A)
Over Active Bladder Instillation Study - Botox [Recruiting]
The purpose of this study is to determine whether women with overactive bladder (OAB) who
receive direct instillation via a catheter of a Botulinum-A Toxin (Botox) with Dimethyl
Sulfoxide (DMSO) solution experience significantly better improvement of their OAB symptoms
when compared to a similar group of women with OAB who receive instillation of DMSO only.
Study Comparing Short Term Efficacy of Dysport� and Dysport RU� to Placebo, and to Assess Efficacy and Safety of Dysport RU� of Subjects With Cervical Dystonia [Recruiting]
The purpose of this study is to evaluate how well a new drug called Dysport RU works and
how safe it is, when it is used for the treatment of cervical dystonia. Dysport RU will be
compared to an approved drug called Dysport.
The Randomized Double-blind Placebo-controlled Trial of Intralesional Botulinum Toxin A Injection for Recalcitrant Alopecia Totalis and Alopecia Universalis [Not yet recruiting]
The main purpose of this study is to determine the efficacy of intralesional botulinum toxin
type A injection for recalcitrant alopecia totalis and alopecia universalis.
Treatments of recalcitrant alopecia totalis and universalis remains an challenge issue for
medical practice. The application of diphenylcyclopropenone (DPCP) is still being an standard
treatment for the condition, however, there are at least thirty percentage of patients
recalcitrant to this treatment.
The complete etiology of this disease has yet to be clear. Nevertheless,recent studies have
demonstrated the hypothesis of neurotransmitter involvements.
There is numerous evidence in support of an imbalance of transmitters, including substance P
and Calcitonin gene-related peptide.
Botulinum toxin A injection has been used to treat a neuralgiform headache and diffused
alopecia areata. Both headache and hair loss have been made much in improvement. This data
may support the neurotransmitter imbalance theory.
The investigators have been informed about possible effects to the alopecia condition,
therefore, this study is conducted to assess the efficacy of botulinum toxin A as the novel
treatment for recalcitrant alopecia totalis and alopecia universalis.
The Value of Botox-A for Management of Low Anterior Resection Syndrome [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.
The Comparison Study of Intralesional Botulinum Toxin A and Corticosteroid Injection for Alopecia Areata [Recruiting]
Alopecia areata is one of the most common cause of non-scarring alopecia. The pathogenesis
is still unclear, however, it is believed to be an autoimmune disease. This disease is not a
life-threatening condition but it has a significant psychological impact to patient's
quality of life.
Many triggers have been proposed such as viral infection, stress and neurologic factors.
There are many studies show the correlation between disease activities and neurotransmitters
level. Substance P and calcitonin gene-related peptide play major role in early stage of
disease. These substances cause imbalance of CD4/CD8 lymphocyte in pathologic site and loss
of immune privilege of hair follicles.
The conventional treatment of alopecia areata with intralesional corticosteroid injection
might treat the end of pathogenesis process.
There is no therapeutic intervention for the origin of disease. Fortunately, botulinum toxin
A could be a novel treatment of alopecia areata. The botulinum toxin A demonstrates
inhibition release of substance P in many publications.
To sum up, the treatment of alopecia areata with intralesional corticosteroid injection
still be a standard treatment, nevertheless, patients have to receive this treatment every
month until regrowth of scalp hair. Corticosteroid injection have several side effects, for
example, skin atrophy, pigmentary change and hypothalamic-pituitary-adrenal axis
suppression. Moreover, injection pain is also affect to psychological aspect .
This study purpose is to evaluate the efficacy of botulinum toxin A for alopecia areata and
reduce corticosteroid side effects, as well as, others opportunity cost. There is no
prospective, randomized-controlled trial of comparison study between botulinum toxin A
injection and corticosteroid injection for alopecia areata, therefore, investigators
conduct this study for the greatest benefit to alopecia areata patients and for the future
research in disease etiology.
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 >>
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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.
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| | 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. |
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Page last updated: 2013-02-10
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