PMID- 23783005 OWN - NLM STAT- MEDLINE DCOM- 20140226 LR - 20220318 IS - 1537-162X (Electronic) IS - 0362-5664 (Linking) VI - 36 IP - 4 DP - 2013 Jul-Aug TI - Dysport (botulinum toxin type A) in routine therapeutic usage: a telephone needs assessment survey of European physicians to evaluate current awareness and adherence to product labeling changes. PG - 122-7 LID - 10.1097/WNF.0b013e318296e630 [doi] AB - BACKGROUND: Botulinum neurotoxin type A is a well-established treatment for a number of conditions involving muscle hyperactivity. Dysport (Ipsen Ltd, Wrexham, United Kingdom) is a botulinum neurotoxin type A preparation that has been available for a number of therapeutic uses for over 20 years in the European Union (EU). This survey was part of the EU botulinum toxin risk management plan to identify potential educational needs of injectors by collecting data on their routine practice administration of Dysport and their awareness of potential adverse events (AEs) that are included in the current product labeling. METHODS: Dysport-experienced injectors in 5 EU countries were surveyed via telephone about their experience of Dysport in patients with cervical dystonia, adult upper and lower limb spasticity, pediatric cerebral palsy, and blepharospasm/hemifacial spasm. RESULTS: The reconstitution dilution volume most often used was 2.5 mL per 500 U for all indications. The mean total dose ranged from 387 to 530 U for cervical dystonia, 508 to 773 U for upper limb spasticity, 600 to 832 U for lower limb spasticity, 375 to 700 U for pediatric cerebral palsy, and 54 to 213 U for blepharospasm/hemifacial spasm. The potential AEs most commonly mentioned by surveyed physicians were dysphagia for cervical dystonia, arm muscle weakness for upper limb spasticity, leg muscle weakness for lower limb spasticity, and pediatric cerebral palsy and ptosis for blepharospasm/hemifacial spasm. CONCLUSIONS: The results indicate that product-labeling recommendations are generally applied in clinical practice and that there is a good familiarity with potential AEs based on clinical condition. Nevertheless, the survey shows that experienced injectors do sometimes deviate from the manufacturers labeling recommendations, highlighting the importance of ongoing education. FAU - Hubble, Jean AU - Hubble J AD - Ipsen Biopharmaceuticals, Inc, Basking Ridge, NJ 07920, USA. FAU - Schwab, Joseph AU - Schwab J FAU - Hubert, Catherine AU - Hubert C FAU - Abbott, Chandra Coleman AU - Abbott CC LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't PL - United States TA - Clin Neuropharmacol JT - Clinical neuropharmacology JID - 7607910 RN - EC 3.4.24.69 (Botulinum Toxins, Type A) RN - EC 3.4.24.69 (abobotulinumtoxinA) SB - IM MH - Adult MH - Blepharoptosis/etiology/*prevention & control MH - Blepharospasm/drug therapy/physiopathology MH - Botulinum Toxins, Type A/administration & dosage/adverse effects/*therapeutic use MH - Cerebral Palsy/drug therapy/physiopathology MH - Child MH - *Clinical Competence MH - Deglutition Disorders/etiology/*prevention & control MH - *Drug Labeling MH - Education, Medical, Continuing MH - European Union MH - Guideline Adherence MH - Hemifacial Spasm/drug therapy/physiopathology MH - Humans MH - Injections, Intramuscular MH - Muscle Spasticity/drug therapy/etiology/physiopathology/prevention & control MH - Muscle Weakness/etiology/*prevention & control MH - Needs Assessment MH - Off-Label Use MH - Pharmacovigilance MH - *Practice Patterns, Physicians' MH - Torticollis/drug therapy/physiopathology EDAT- 2013/06/21 06:00 MHDA- 2014/02/27 06:00 CRDT- 2013/06/21 06:00 PHST- 2013/06/21 06:00 [entrez] PHST- 2013/06/21 06:00 [pubmed] PHST- 2014/02/27 06:00 [medline] AID - 10.1097/WNF.0b013e318296e630 [doi] PST - ppublish SO - Clin Neuropharmacol. 2013 Jul-Aug;36(4):122-7. doi: 10.1097/WNF.0b013e318296e630.