Botulinum toxin: Does the black box warning justify change in practice?

Developmental Medicine and Child Neurology

Volumn 53, Issue 2, 2011, Pages 101-102

  Narayanan, Unni G ^a  

^a University of Toronto   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

BOTULINUM TOXIN;

ASPIRATION; CEREBRAL PALSY; CLINICAL PRACTICE; DRUG FATALITY; DYSPHAGIA; FOOD AND DRUG ADMINISTRATION; GROSS MOTOR FUNCTION CLASSIFICATION SYSTEM; HUMAN; MEDICAL RESEARCH; NOTE; PNEUMONIA; PRIORITY JOURNAL; RESPIRATORY TRACT INFECTION; SIDE EFFECT; SPASTICITY; UNITED STATES; WEAKNESS;

ADVERSE DRUG REACTION REPORTING SYSTEMS; ANTI-DYSKINESIA AGENTS; BOTULINUM TOXINS; BOTULINUM TOXINS, TYPE A; CEREBRAL PALSY; CHILD; CLINICAL TRIALS AS TOPIC; DRUG LABELING; DRUG TOXICITY; HUMANS; INJECTIONS, INTRAMUSCULAR; RISK; TREATMENT OUTCOME; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 78751503271     PISSN: 00121622     EISSN: 14698749     Source Type: Journal    
DOI: 10.1111/j.1469-8749.2010.03870.x     Document Type: Note

References (6)

1. Petition to the FDA requesting regulatory action concerning the possible spread of botulinum toxin from the site of injection to other parts of the body (HRG Publication #1834). (accessed 1 December 2010).
2. US Food and Drug Administration. Early Communication about an ongoing safety review of botox and botox cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B). February 2008. (accessed 12 October 2010).
3. US Food and Drug Administration. Response to Citizen's Petition. April 2009. (accessed 1 December 2010).
4. US Food and Drug Administration. Early Communication about an Ongoing Safety Review of Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B). April 2009. (accessed 1 December 2010).
5. US Food and Drug Administration. Information for Healthcare Professionals: OnabotulinumtoxinA (marketed as Botox/Botox Cosmetic), AbobotulinumtoxinA (marketed as Dysport) and RimabotulinumtoxinB (marketed as Myobloc). August 2009. (accessed 1 December 2010).
6. O'Flaherty S, Janakan V, Morrow A, Scheinberg A, Waugh M. Botulinum toxin A adverse events and health status in children with cerebral palsy in all GMFCS levels. Dev Med Child Neurol 2011; 53: 125-30. DOI: .