"March 20, 2012 -- Almost 9.2 million cosmetic procedures were performed in the United States in 2011, and Americans spent nearly $10 billion on cosmetic procedures last year.
These are some of the key findings in the new statistics fr"...
(abobotulinumtoxinA) for Intramuscular Injection
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 in approved indications, cases of spread of effect have been reported at doses comparable to or lower than the maximum recommended total dose. [see WARNINGS AND PRECAUTIONS]
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. It is purified from the culture supernatant by a series of precipitation, dialysis, and chromatography steps. The neurotoxin complex is composed of the neurotoxin, hemagglutinin proteins and non-toxin non-hemagglutinin protein.
DYSPORT® is supplied in a single-use, sterile vial for reconstitution intended for intramuscular injection. Each vial contains 300 Units or 500 Units of lyophilized abobotulinumtoxinA, human serum albumin (125 mcg) and lactose (2.5 mg). DYSPORT® may contain trace amounts of cow's milk proteins [see CONTRAINDICATIONS].
One unit of DYSPORT® corresponds to the calculated median lethal intraperitoneal dose (LD50) in mice. The method for performing the assay is specific to Ipsen's product DYSPORT®. Due to differences in specific details such as vehicle, dilution scheme and laboratory protocols for various mouse LD50 assays, Units of biological activity of DYSPORT® are not interchangeable with Units of any other botulinum toxin or any toxin assessed with any other specific assay method [see Dosage Forms and Strengths].
What are the possible side effects of Dysport (Dysport)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.
The botulinum toxin contained in Dysport can spread to other body areas beyond where it was injected. This has caused serious life-threatening side effects in some people receiving botulism toxin injections, even for cosmetic purposes.
Call your doctor at once if you have any of these serious side effects, some of which can occur up to several weeks after an...
Last reviewed on RxList: 3/17/2016
This monograph has been modified to include the generic and brand name in many instances.
Additional Dysport Information
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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