Surgeon in Ophthalmology, Massachusetts Eye and Ear Infirmary,

Assistant Clinical Professor, Harvard Medical School

Medical Director Associate Eye Physicians and Surgeons, Inc

Articles

Safety

The statement on the Safety of Botulinum Toxin products (Botox, Myobloc, Xeomin and Dysport). 

Recently, the common press has published articles dealing with potential serious complications associated with the use of botulinum toxin, particularly Botox, for the treatment of certain diseases.  It should be pointed out that these products have been used extensively by experienced physicians without significant risk for decades.

The center of the recent controversy has emerged from two observations.  The first observation was made from a scientific study using botulinum toxin at high doses which revealed the toxin moved along nerves into the brain.   This observation, however, was in doses that were far in excess of which are conventionally used for human treatment. To date, no long term neurotoxicity has ever been demonstrated using these agents.  The mere fact that a drug can move into the brain does not mean that it is potentially damaging; for instance, antihistamines, sedatives and other type medications can penetrate the brain without any lasting or enduring side effects.  To date there has been no neurologic side effects associated with the long term use of botulinum toxin.  Dr. Borodic has served on safety committees, and as safety monitor for a number of clinical studies, and has used the medication for over 28 years.  He has had no serious side effects in his practice with long term use of this medication.

The second category of sides effects associated with the use of botulinum toxin emerged from use of botulinum toxin for the treatment of cerebral palsy.  In this area of very large dose applications, there can be substantial and serious side effects if the drug is used imprudently without regard to dosing limitations and injection placement. In certain rare cases, diffusion of the toxin at high doses leads to dangerous systemic weakness.  One has to understand that the cosmetic and facial application of botulinum toxin as well as the applications in the human neck are in doses far less than those that had been advocated for children and some adults with spasticity and cerebral palsy that have suffered from substantial adverse effects from diffusion of the toxin.  Some academic manuscripts had advocated doses far in excess of which should be used safely, particularly for children with cerebral palsy.   Most recently this has led to a fine of the manufacturer of botulinum toxin, Allergan for over $600 million for off label promotion for this indication.

Patients in Dr. Borodic’s practice should be assured that this dose will not be used in any such patients and this has not been a problem at Associated Eye Physicians and Surgeons, Inc. in its 30 year history.

Gary E. Borodic. MD

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F: 617.770.0030 

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