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BOTOX RISKS 2008

FDA NEWS: WARNS OF IMPORTANT BOTOX RISKS

FDA, on 8 February 2008 flagged the potential inherent dangers and side-effects of the neurotoxin, botulinum in clinical practice and aesthetic or cosmetic medicine ( skin and beauty). FDA is carefully monitoring adverse side-effect of incoming reports, updating the public and medical profession, but at this stage is not advising health care professionals to discontinue prescribing the products (www.dailyindia.com, www.fda.gov, www.reuters.com , www.msn.com.). But the warning and drug toxicity by the US watchdog, nonetheless, needs to be taken seriously by all SPA’S, Medispa’s and doctors injecting botulinum as anti-wrinkle treatment in cosmetic practice, according to BOLANDCELL, consultants.

Public Citizen, recommended a “ black box” against Allergan INC’s Botox and Solstice Neuroscience INC’s Myobloc during February 2008 ( www.msnbc.com, www.news24.com: of 9/2/2008). Public Citizen have reviewed 180 adverse case reports following the use of botulinum and submitted to FDA. Sixteen of the cases reported were fatal, including 4 involving children under 18 years, many of which were hospitalized ( www.msn.com, of 9/2/2008 ).Clearly, investigation to ensure credibility, accountability of the medical and dental profession, proficiency, ability and training of professionals, proper management of cosmetic clinics by authorized medical doctors  in order to protect the public, is needed. 

According to www.reuters.com , European regulators have warned physicians to watch for signs of botulinum toxin complications, post injection, most recently in March 2007.

Although botulinum is FDA approved for specific indications (including the cosmetic industry) post approval surveillance has clearly shown that botulinum is indeed a potent neurotoxin, can spread/dissipate after injection into unexpected anatomical tissue planes beyond the intended target ( distant sites), be absorbed into the blood stream, causes the botulinum syndrome, and occasionally death in young children (www.msn.com). This must be understood by practicing health care professionals using botulinum to avoid disastrous consequences as announced by Public Citizen in the United States. BOLANDCELL, suspect this only reflects the tip of the iceberg and that there are many other cases that have gone unreported or attributed to other causes. Although thousands of Botox  injections are given daily, the potential for anatomical toxin tracking ( albeit clinically rare) will always be there, with risk to the airway and oesophagus in susceptible persons. Training in appropriate clinical anatomy relevant to botulinum injection, potential for tracking to distant sites, apart from drug pharmacology, should be included in workshops.

Other important side effects of botulinum include: partial or complete paralysis of the oesophageal muscles at the pharyngeal level, resulting in swallowing disorders (iatrogenic dysphagia) up to 6 months and requiring a feeding tube, blurring of vision, aspiration pneumonia because delicate pharyngeal reflexes are lost allowing aspiration of food particles and saliva into the bronchial and lung tree, as well as  botulism. The warnings from FDA are justifiable and will hopefully allow doctors to more effectively medically intervene earlier ( www.msn.com). FDA, in FDA News, on February 8, 2008, flagged Botox and Botox Cosmetic and Myobloc, linking them in some cases to adverse reactions, including respiratory failure and death, following treatment of a variety of conditions using a wide range of doses (www.fda.gov, Feb 8, 2008). FDA provides important background information and advice for health care professionals. This is important educational data, allowing corrective treatment, because the use of botulinum is not properly taught at medical schools, does not appear in medical curricula, is often used by junior and inexperienced general practitioners in cosmetic business who are exploited by trade, and are not aware of the botulism syndrome. Many have forgotten their neuroanatomy and don’t remember the danger of cranial nerve and pharyngeal muscle paralysis, and implications for swallowing and airway control in the larynx area. Most have blinkers on and are only concerned with wrinkle reduction, focused on financial remuneration, financial reward and greed, and are oblivious to the potential anatomical hazards of tracking neurotoxin to airway control muscles and reflexes.

Minute quantities of botulinal toxin, can cause botulism (see THE MERCK MANUAL). Neurological involvement is typical, whilst GIT symptoms are absent, like wound induced botulism. Neuromuscular disturbance should be detected early. The greatest threat to life is from respiratory impairment and its complications (Merck Manual). Progressive paralysis with airway obstruction occurs suddenly, is dangerous with potential of asphyxia, and intubation and ventilation may be urgently needed with admission to ICU. This has also been emphasized by Professor Donald du Toit, PHD, FRCS, of The University of Stellenbosch in Cape Town. Absorption of the toxin after cosmetic injection may be via the orbital (cavernous venous sinus) and cervical venous plexus (internal jugular vein) in which case the toxin rapidly reaches the respiratory muscles and the clinical outcome is serious and occasionally fatal. Even therapeutically approved doses of botulinum are capable of these outcomes and short-middle-term patient follow-up is needed. The following anatomical dissection of the human face, shows vital structures and veins into which cosmetically injected botulinum toxin can track and be embolised to respiratory muscles and pharyngeal constrictors/oesophageal musculature.


Legend to Illustration: Cadaveric deep dissection of the human face. Left anterolateral aspect and profile showing parotid duct (3), angular vein (9), and facial artery (14). Facial muscles of expression (supplied by the motory, facial nerve) have been excised, but lie in close proximity to these vital demonstrated anatomical structures. Note inferior periorbital venous plexus of the left eye/orbit, feeding venules and proximity to the angular vein cursing in the deep component of the naso-labial fold (drainage is inferior wards to the internal jugular vein). Botulinum toxin-A ( Botox®, Dysport®), injected and deposited or targeted into the periorbital region for cosmetic purposes, to ameliorate wrinkles and fine lines, can track, uninhibitedly, into the adjacent vein lumen, and quickly be swept away via the venous system to paralyze respiratory muscles, in susceptible persons. The same applies to the anterior neck region/triangle and décolleté, and injected botulinum toxin, can track quickly through the investing layer of the deep cervical fascia, to iatrogenically paralyze the pharyngeal constrictor muscles, precipitating dysphagia with loss of airway control and asphyxia. See Moore’s Clinical Anatomy for more detail regarding structure relationships.

CLASSIC FEATURES OF BOTULISM (AFTER DAVIDSON): TOXIN MEDIATED POISONING

  • Paresis of skeletal, ocular, pharyngeal and respiratory muscles
  • Morbidity and mortality can be high

 BOLANDCELL ACADEMIC REFERENCES 2008: BOTULINUM TOXICITY RELEVANT TO CLINICAL PRACTICE

1. The Merck Manual. See details on botulism.
2. Moore’s Anatomy textbook. See detail on the venous drainage of the orbit.
3 .Gray’s Anatomy. See venous drainage of the orbit.
4. Ganong: Review of Medical Physiology: page 87. Details on botulism.
5 .Civetta et al. Critical care. Lippincott. Details on botulism
6. Partikian A, et al. Iatrogenic botulism in a child with spastic quadriparesis. J  Child Neurol.
2007;22: 1235-7. Reversible outcome.
7. Souayah N, et al. Severe botulism after focal injection of botulinum toxin. Neurology.2006:28;67.1855-6.
8. Iatrogenic botulism in an amateur weight-lifter. Mov Disord 2006.
9. Davidson’s Principles and Practice of Medicine. Churchill-Livingstone
10. Davis, Dulbecco et al. Microbiology. Hoeber.

BOLANDCELL WEBSITE, INTERNET REFERENCES AND LINKS FEBRUARY 2008: BOTULINUM TOXICITY RELEVANT TO CLINICAL PRACTICE

Compiled by an experienced specialist clinician, schooled in surgery and the art of aesthetic medicine, Faculty of IMCAS 2008 and internationally recognized academic anatomist in Cape Town. February 9, 2008.

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