Summary: Botulinum is a nerve
toxin made by the food poisoning bacteria Clostridium Botulinum. It causes a
time-bound paralysis in affected muscles. Diluted purified Botulinum toxin is
injected into muscles in persistent spasm, to cause a calculated degree of
flaccid paralysis, so that the remaining viable muscles can obey voluntary
muscular commands in a better coordinated way. However this mode of therapy has
certain limitations. Last updated August 5, 2009
BOTULINUM /PHENOL INJECTIONS IN CP: PRESENT
The rapidity of relief from spasticity in Spastic CP with Botulinum
Muscle Infiltration Injection (which can be used a number of times) or
Phenol Nerve Block (which may be used relatively safely about twice) is
magical. However, the effects are temporary, up to 4 to 8 months in most
cases of CP.
Initially, we tried them a number of times, but have since used it rarely.
It gives so much initial relief that it takes away the drive to continue
intensive OT/PT by the child and parents. The net result in most cases is
"Back to the Pavilion" in a few months. In contrast, tendon lengthening surgery costs
just a wee bit more than these injections, and the effects are permanent.
We prefer that if very necessary.
FDA issues warning about the use of Botulinum in cerebral palsy .... More
Medscape notification: From Medscape Medical News
Alerts, Approvals and Safety Changes
Botulinum Toxin Safety Warnings Updated and Name Changes Issued
August 4, 2009 — The US Food and Drug Administration (FDA) has announced revisions to both the prescribing information and the names of botulinum toxin products.
An alert sent yesterday from MedWatch, the FDA's safety information and adverse event reporting program, describes updates to previous safety alerts on 4 botulinum toxin drug products, noting that all of them now have boxed warnings on their labels. In addition, medication guides have been issued for patients, as directed by the agency in April 2009.
The following revisions to the prescribing information of Botox/Botox Cosmetic (Allergan, Inc) and Myobloc (Solstice Neurosciences, Inc) have been made: a boxed warning now highlights the possibility of experiencing potentially life-threatening distant spread of toxin effect from the injection site after local injection, and, a risk evaluation and mitigation strategy that includes a patient-directed medication guide has been issued. Changes also have been made to the established drug names to reinforce individual potencies and prevent medication errors.
Established name changes for the 4 botulinum toxin products are as follows:
Botox/Botox Cosmetic: new name: onabotulinumtoxinA; old name: botulinum toxin type A
Dysport (Medicis Pharmaceutical Corporation): new name: abobotulinumtoxinA; old name: botulinum toxin type A (approved April 29, 2009)
Myobloc: new name: rimabotulinumtoxinB; old name: botulinum toxin type B
"The potency units are specific to each botulinum toxin product, and the doses or units of biological activity cannot be compared or converted from one product to any other botulinum toxin product," the FDA notes. "The new established names reinforce these differences and the lack of interchangeability among products," the agency adds.
According to an FDA press release, symptoms associated with distant spread of toxin effect from the injection site have been reported mostly in children with cerebral palsy being treated for muscle spasticity, a nonapproved use of the drug. "Symptoms have also been reported in adults treated both for approved and unapproved uses," the FDA states. However, no definitive serious adverse event reports of distant spread of toxin effect have been associated with dermatologic uses such as glabellar lines or hyperhidrosis.
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