PMID- 34187265
OWN - NLM
STAT- MEDLINE
DCOM- 20211103
LR  - 20211103
IS  - 1744-764X (Electronic)
IS  - 1474-0338 (Linking)
VI  - 20
IP  - 11
DP  - 2021 Nov
TI  - OnabotulinumtoxinA for the prophylactic treatment of headaches in adult patients 
      with chronic migraine: a safety evaluation.
PG  - 1275-1289
LID - 10.1080/14740338.2021.1948531 [doi]
AB  - Introduction: Existing oral prophylaxis for chronic migraine (CM) are often 
      ineffective or poorly tolerated. OnabotulinumtoxinA (onabotA) is approved for 
      headache prophylaxis in CM and ameliorates headaches in patients refractory to 
      multiple preventatives.Areas covered: We appraise evidence regarding action 
      mechanisms, pharmacodynamics, and pharmacokinetics of onabotA in CM prophylaxis. 
      We critically evaluate salient clinical and real-world studies demonstrating its 
      efficacy in improving multiple aspects of CM. We discuss onabotA safety, 
      tolerability, and adverse events (AEs) for CM prophylaxis from clinical trials, 
      post-authorization studies and meta-analyses, including novel pregnancy safety 
      data and comparisons with oral prophylactics. We explore areas of future 
      interest, particularly onabotA safety and efficacy in the context of novel 
      antibody-based prophylaxis.Expert opinion: Clinical and real-world evidence 
      demonstrate onabotA safety, tolerability and efficacy for CM prophylaxis. Most 
      AEs are mild/moderate and self-limiting, with few serious AEs and no 
      treatment-related deaths. Common AEs include neck pain, ptosis, muscle weakness, 
      and stiffness. Modifying existing responder-criteria enables more patients to 
      benefit from onabotA. OnabotA shows superior safety and efficacy to oral 
      preventatives, and appears safe in pregnancy. Future pregnancy-risk register will 
      clarify pregnancy and lactation safety further. Future research comparing onabotA 
      safety and efficacy with newly emergent antibody-based prophylaxis is keenly 
      awaited.
FAU - Cheng, Fan
AU  - Cheng F
AD  - Department of Neurosciences, Hull University Teaching Hospitals NHS Trust, Hull, 
      UK.
FAU - Ahmed, Fayyaz
AU  - Ahmed F
AD  - Department of Neurosciences, Hull University Teaching Hospitals NHS Trust, Hull, 
      UK.
LA  - eng
PT  - Journal Article
PT  - Review
DEP - 20210705
PL  - England
TA  - Expert Opin Drug Saf
JT  - Expert opinion on drug safety
JID - 101163027
RN  - 0 (Neuromuscular Agents)
RN  - EC 3.4.24.69 (Botulinum Toxins, Type A)
RN  - EC 3.4.24.69 (onabotulinum toxin A)
SB  - IM
MH  - Adult
MH  - Animals
MH  - Botulinum Toxins, Type A/*administration & dosage/adverse effects/pharmacology
MH  - Headache/prevention & control
MH  - Humans
MH  - Migraine Disorders/*drug therapy/physiopathology
MH  - Neuromuscular Agents/*administration & dosage/adverse effects/pharmacology
OTO - NOTNLM
OT  - Onabotulinumtoxin a
OT  - chronic migraine
OT  - prophylaxis
OT  - safety
OT  - tolerability
EDAT- 2021/07/01 06:00
MHDA- 2021/11/04 06:00
CRDT- 2021/06/30 05:29
PHST- 2021/07/01 06:00 [pubmed]
PHST- 2021/11/04 06:00 [medline]
PHST- 2021/06/30 05:29 [entrez]
AID - 10.1080/14740338.2021.1948531 [doi]
PST - ppublish
SO  - Expert Opin Drug Saf. 2021 Nov;20(11):1275-1289. doi: 
      10.1080/14740338.2021.1948531. Epub 2021 Jul 5.