Affiliations: [a] Baylor College of Medicine, Houston, TX, USA | [b] Texas Children’s Hospital, Houston, TX, USA
Corresponding author: Edward Wright, Baylor College of Medicine and Texas Children’s Hospital, Houston, 17580 I-45 South, Suite 1280.77030, The Woodlands, TX 77384, USA. Tel.: +1 936 2677132, +1 405 4128567; Fax: +1 936 2677906; E-mail: [email protected].
Abstract: Serious adverse events (serious AEs) following the therapeutic use of Botulinum Toxin Type A (BoNT-A) are infrequent. Children with pediatric spasticity often have comorbidities that can cloud causation around an adverse event (AE). If a serious AE occurs, clear documentation of information sharing and informed consent as well as the provider-patient relationship are critical to minimizing litigation risks. Reviewing the litigation that has occurred following BoNT-A for pediatric spasticity can offer insight into how providers’ perspectives regarding this intervention may differ from those of the public who might serve as jurists. This article offers suggestions for content sharing during the consent process to optimize patient understanding about potential adverse events.
Keywords: FDA label, indication, off label drug use, serious adverse events, idiosyncratic reactions, Black Box Warning, consent, information sharing, causation, Botulinum Toxin Type A, pediatric spasticity, Cerebral Palsy, medication guide