PMID- 25443898
OWN - NLM
STAT- MEDLINE
DCOM- 20150212
LR  - 20181202
IS  - 1527-9995 (Electronic)
IS  - 0090-4295 (Linking)
VI  - 84
IP  - 5
DP  - 2014 Nov
TI  - Incidence of adverse events after high doses of onabotulinumtoxinA for multiple 
      indications.
PG  - 1044-8
LID - S0090-4295(14)00826-7 [pii]
LID - 10.1016/j.urology.2014.07.046 [doi]
AB  - OBJECTIVE: To determine the occurrence of all treatment-related adverse events 
      (AEs), especially life-threatening AEs, after the injection of a cumulative dose 
      of >360 units of onabotulinumtoxinA for multiple indications (neurogenic detrusor 
      overactivity, lower limb spasticity, and so forth) within a 3-month interval. 
      METHODS: This is a retrospective cohort study of patients who received >360 units 
      of onabotulinumtoxinA within a 3-month interval, with at least 1 urologic 
      indication for injection, between January 1, 2002 and January 1, 2013. The rate 
      of treatment-related AE up to 8 days after injection and life-threatening AE up 
      to 90 days after injection was compared between the injection sessions below and 
      exceeding the maximum dosage recommendations. RESULTS: Thirteen patients met the 
      study criteria. Eleven were female patients and had a diagnosis of multiple 
      sclerosis. Sixty-five injection sessions involved >360 units of 
      onabotulinumtoxinA administered within a 90-day interval. Median interval between 
      injections was 54 days (interquartile range [IQR], 30-71 days) and median dose 
      administered was 800 units (IQR, 600-1000 units). Seventy injection sessions 
      involved <360 units of onabotulinumtoxinA administered >90 days after prior 
      injection. Median interval between these injections was 113 days (IQR, 97-158 
      days) and median dose administered was 200 units (IQR, 100-300 units). The 
      maximum cumulative dosage injected was 1900 units (1500 units for lower 
      extremities and 400 units for bladder). This patient did not experience any AE. 
      There was a total of 6 AEs (general and/or extremity weakness or leg pain) that 
      occurred in 4 patients, of a total of 183 injection sessions. These AEs all 
      eventually resolved. There were no life-threatening AEs in either group. 
      CONCLUSION: This is the first report of patients receiving >360 cumulative units 
      of onabotulinumtoxinA within a 3-month interval for multiple indications. There 
      were no life-threatening AEs. This study provides preliminary data on 
      administration of high doses of onabotulinumtoxinA for multiple indications.
CI  - Copyright (c) 2014 Elsevier Inc. All rights reserved.
FAU - Nuanthaisong, Umaphorn
AU  - Nuanthaisong U
AD  - Department of Urology, Center for Female Pelvic Medicine and Reconstructive 
      Surgery, Glickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, 
      OH; Urology Unit, Department of Surgery, Faculty of Medicine, Vajira Hospital, 
      Navamindradhiraj University, Bangkok, Thailand.
FAU - Abraham, Nitya
AU  - Abraham N
AD  - Department of Urology, Center for Female Pelvic Medicine and Reconstructive 
      Surgery, Glickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, 
      OH. Electronic address: nitya.abraham@gmail.com.
FAU - Goldman, Howard B
AU  - Goldman HB
AD  - Department of Urology, Center for Female Pelvic Medicine and Reconstructive 
      Surgery, Glickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, 
      OH.
LA  - eng
PT  - Journal Article
DEP - 20141024
PL  - United States
TA  - Urology
JT  - Urology
JID - 0366151
RN  - EC 3.4.24.69 (Botulinum Toxins, Type A)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Botulinum Toxins, Type A/administration & dosage/*adverse effects
MH  - Extremities/pathology
MH  - Female
MH  - Humans
MH  - Incidence
MH  - Male
MH  - Middle Aged
MH  - Multiple Sclerosis/*complications/drug therapy
MH  - Muscle Spasticity/drug therapy
MH  - Retrospective Studies
MH  - Time Factors
MH  - Treatment Outcome
MH  - Urinary Bladder, Overactive/drug therapy
MH  - Urinary Incontinence/*drug therapy
EDAT- 2014/12/03 06:00
MHDA- 2015/02/13 06:00
CRDT- 2014/12/03 06:00
PHST- 2014/06/16 00:00 [received]
PHST- 2014/07/22 00:00 [revised]
PHST- 2014/07/27 00:00 [accepted]
PHST- 2014/12/03 06:00 [entrez]
PHST- 2014/12/03 06:00 [pubmed]
PHST- 2015/02/13 06:00 [medline]
AID - S0090-4295(14)00826-7 [pii]
AID - 10.1016/j.urology.2014.07.046 [doi]
PST - ppublish
SO  - Urology. 2014 Nov;84(5):1044-8. doi: 10.1016/j.urology.2014.07.046. Epub 2014 Oct 
      24.