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Botulinum Toxin - Botox® Dysport® Xeomin®

Botulinum toxin is an extremely potent poison, originally developed as a nerve gas before the Second World War. Its therapeutic use is now recognised in a range of symptoms. Botulinum toxin is a drug that may be used to treat spasticity and spasms. Researchers are also looking into the drug as a treatment for bladder problems.

 

How botulinum toxin works                                                                                                                                                                                                        

By preventing nerve messages being transmitted to muscles, thus causing paralysis. In small, therapeutic doses, botulinum toxin is injected into individual muscles to prevent the nerve messages that cause spasticity and spasm. The effects of an injection with botulinum toxin can last from six to ten months.

 

How is botulinum toxin given?                                                                                                                                                                                                   

Botulinum toxin is injected - injections have to be delivered by a professional trained in the technique.

 

 

Side effects may occur                                                                                                                                                                                                                

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-approved and unapproved uses. The reactions reported are suggestive of botulism, which occurs when botulinum toxin spreads in the body beyond the site where it was injected.

The most serious cases had outcomes that included hospitalisation and death, and occurred mostly in children treated for cerebral palsy-associated limb spasticity.

Use of botulinum toxins for treatment of limb spasticity (severe arm and leg muscle spasms) in children or adults is not an approved use in the U.S.

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-marketing adverse event reports and the medical literature.

Botox - botulinum toxin type A

• 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

• 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-threatening systemic toxicity from the use of botulinum toxin products can also result after local injection in patients with other underlying conditions such as those with cerebral palsy associated limb spasticity. 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:

• 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
• Be alert to the potential for systemic effects following administration of botulinum toxins such as: dysphagia, dysphonia, weakness, dyspnea or respiratory distress
• Understand that these effects have been reported as early as one day and as late as several weeks after treatment
• 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
• 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 the data?

The FDA has reviewed post-marketing cases from its Adverse Event Reporting System (AERS) database and from the medical literature of pediatric and adult patients diagnosed with botulism following a local injection with a marketed botulinum toxin product.

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.

 

 

MS - First used to treat spasticity in MS in 1990. There are several different types of the toxin, with botulinum toxin A the one most frequently used in MS. Botulinum toxin is only available in a few specialist centres in the UK - access can be difficult. [1]

1. Snow BJ, et al.Treatment of spasticity with botulinum toxin: a double-blind study. Annals of Neurology 1990;28(4):512-515.

 

Other web sites                      

fda.gov/cder/drug

fda.gov/medwatch

 

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