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Early Communication about an Ongoing Safety Review
Botox and Botox Cosmetic (Botulinum
toxin Type A) and
Myobloc (Botulinum toxin Type B)
This information reflects FDA’s current analysis of available data concerning these
drugs. Posting this information does not mean that the FDA has concluded there is
a causal relationship between the drug products and the emerging safety issue. Nor
does it mean that FDA is advising healthcare professionals to discontinue prescribing
these products. FDA is considering, but has not reached a conclusion about whether
this information warrants any regulatory action. FDA intends to update this document
when additional information or analyses become available.
FDA has received reports of systemic adverse reactions including respiratory compromise
and death following the use of botulinum toxins types A and B for both FDA-
These serious systemic adverse reactions occurred following treatment of a variety
of conditions using a wide range of botulinum toxin doses. FDA is currently reviewing
safety data from clinical studies submitted by the manufacturers of Botox, Botox
Cosmetic and Myobloc, as well as post-
Botox (botulinum toxin type A) is approved for treatment of conditions such as blepharospasm (spasm of the eyelids), cervical dystonia (severe neck muscle spasms), and severe primary axillary hyperhydrosis (excess sweating). Botox Cosmetic, also botulinum toxin Type A, is approved for temporary improvement in the appearance of moderate to severe facial frown lines.
Myobloc (botulinum toxin Type B) is approved for the treatment of adults with cervical dystonia; the safety and effectiveness of Myobloc for cervical dystonia in children have not been established.
FDA is aware of the body of literature describing the use of botulinum toxins to treat limb spasticity in children and adults. The safety, efficacy and dosage of botulinum toxins have not been established for the treatment of limb spasticity of cerebral palsy or for use in any condition in children less than 12 years of age.
The current prescribing information (labelling) for Botox, Botox Cosmetic and Myobloc describes adverse reactions occurring in regions near the site of injection for each product’s approved uses, such as dysphagia (difficulty swallowing) after injections to treat cervical dystonia, or ptosis (drooping eye lids) after injections for glabellar frown lines or for strabismus and blepharospasm.
The Warnings sections of the labelling for both botulinum toxin products note that important systemic adverse effects, including severe difficulty swallowing and difficulty breathing have occurred in patients with neuromuscular disorders after local injection of typical doses of botulinum toxin.
FDA now has evidence that similar, potentially life-
Systemic toxicity has been reported in children, several of whom required feeding tubes and/or ventilation (breathing) support.
Until such time that FDA has completed its review, healthcare professionals who use medicinal botulinum toxins should:
1. Understand that potency determinations expressed in “Units” or “U” are different among the botulinum toxin products; clinical doses expressed in units are not comparable from one botulinum product to the next
2. Be alert to the potential for systemic effects following administration of botulinum toxins such as: dysphagia, dysphonia, weakness, dyspnea or respiratory distress
3. Understand that these effects have been reported as early as one day and as late as several weeks after treatment
4. Provide patients and caregivers with the information they need to be able to identify the signs and symptoms of systemic effects after receiving an injection of a botulinum toxin
5. Tell patients they should receive immediate medical attention if they have worsening or unexpected difficulty swallowing or talking, trouble breathing, or muscle weakness
What does FDA know now about these data?
The FDA has reviewed post-
The pediatric botulism cases occurred in patients less than 16 years old, with reported symptoms ranging from dysphagia to respiratory insufficiency requiring gastric feeding tubes and ventilatory support. Serious outcomes included hospitalisation and death. The most commonly reported use of botulinum toxin among these cases was treatment of limb muscle spasticity associated with cerebral palsy. For Botox, doses ranged from 6.25 to 32 Units/kilogram (U/kg) in these cases. For Myobloc, reported doses were from 388 to 625 U/kg.
The reports of adult botulism cases described symptoms including patients experiencing difficulty holding up their heads, dysphagia and ptosis. Some reports described systemic effects that occurred distant from the site of injection and included weakness and numbness of the lower extremities. Among the adult cases that were serious, including hospitalisation, none required intubation or ventilatory support. No deaths were reported. The doses for Botox ranged from 100 to 700 Units and for Myobloc from 10,000 to 20,000 Units.
This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. FDA will communicate to the public its conclusions, resulting recommendations, and any regulatory actions after the review of the data are completed.
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Report serious adverse events to FDA’s MedWatch reporting system by completing a form on line at
By faxing (1-
By mail using the postage-
(5600 Fishers Lane, Rockville, MD 20853-
By telephone (1-
