Knowledge map of thrombopoietin receptor agonists: A bibliometric analysis.

Thrombopoietin receptor agonists (TPO-RAs) have been widely used to treat thrombocytopenia, however, a scientometric profile of TPO-RAs research is lacking. Methods: This study uses VOSviewer, CiteSpace, and R software to provide an overview of current research, highlight study hotspots, and predict future research directions of TPO-RAs. Results: One thousand seven hundred and nineteen relevant studies from 1993 to 2022 with 43962 citations were identified from the Web of Science Core Collection. Over three decades, the USA has been leading TPO-RAs publications. Industries and academic institutions have been actively involved in TPO-RAs research, with funding provided by pharmaceutical companies and public funding bodies. The most productive and cited journals are British Journal of Hematology and Blood, respectively. When author keywords were categorised into three clusters, i.e., cluster 1 (immune thrombocytopenic purpura (ITP)), cluster 2 (avatrombopag, lusutrombopag, and thrombocytopenia), and cluster 3 (TPO-RAs for ITP and off-label drug use), ITP was found to be the current research hotspot, while oral TPO-RAs and licensed or unlicensed drug indications of thrombocytopenic diseases require further investigation. Conclusion: This study has generated the knowledge map of TPO-RAs, which provides a dynamic roadmap for future research in this field.

Korean Brain Tumor Society Consensus Review for the Practical Recommendations on Glioma Management in Korea.

Recent updates in genomic-integrated glioma classification have caused confusion in current clinical practice, as management protocols and health insurance systems are based on evidence from previous diagnostic classifications. The Korean Brain Tumor Society conducted an electronic questionnaire for society members, asking for their ideas on risk group categorization and preferred treatment for each individual diagnosis listed in the new World Health Organization (WHO) classification of gliomas. Additionally, the current off-label drug use (OLDU) protocols for glioma management approved by the Health Insurance Review and Assessment Service (HIRA) in Korea were investigated. A total of 24 responses were collected from 20 major institutes in Korea. A consensus was reached on the dichotomic definition of risk groups for glioma prognosis, using age, performance status, and extent of resection. In selecting management protocols, there was general consistency in decisions according to the WHO grade and the risk group, regardless of the individual diagnosis. As of December 2022, there were 22 OLDU protocols available for the management of gliomas in Korea. The consensus and available options described in this report will be temporarily helpful until there is an accumulation of evidence for effective management under the new classification system for gliomas.

Judicial and legislative practice and related suggestions on off-label drug use in China.

BACKGROUND: Off-label drug use exists widely in medical practice and is also an area which easily triggers controversy between patients and medical institutions. Previous studies have identified the reasons why off-label drug use long exists. However, there is no multidimensional analysis on real judicial precedents about off-label drug use. This study aimed to investigate the dispute points on off-label drug use based on real cases in China, and proposed suggestions based on newly-leased Physicians Law. METHODS: Our study is a retrospective study with all the 35 judicial precedents on off-label drug use extracted from China Judgments Online from 2014 to 2019. This study mainly used the methods of statistical analysis, inferential analysis, exemplification, literature summarization and comparative analysis. RESULTS: According to the analysis of the 35 precedents of jurisdictions from 11 different aspects, it can be seen that the second-instance and retrial rates of this kind of cases are high, and the disputes between patients and medical institutions are fierce. In judicial practice of off-label drug use, medical institutions are determined whether to bear civil liability according to the constituent elements of medical tort liability: the rate of medical institutions' bearing liability for off-label drug use is not high, and medical institutions are not directly identified as infringing acts and they don't bear tort liability. The clear provisions about off-label drug use in Law of the People's Republic of China on Physicians which was implemented in March 2022 confirm this at the legislative level. CONCLUSIONS: By analyzing the current judicial practice of China's off-label drug use cases, and summarizing the dispute points between medical institution and patients, the constituent elements of tort liability, and the rules of evidence etc., suggestions are proposed to further regulate off-label drug use and promote safe and rational drug use.

Expert consensus on off-label drug use in the three Northeastern provinces of China（solid tumors and hematology） / 中国药房

OBJECTIVE To provide theoretical basis for the rational use of drugs in medical institutions， assist in improving the quality of pharmaceutical services， and thus meet clinical drug demands. METHODS Adopting consensus meetings， Liaoning Pharmaceutical Association，Jilin Pharmaceutical Association and Heilongjiang Pharmaceutical Association collaborated with clinical and pharmaceutical experts in the region to compile the expert consensus on off-label drug use in the three Northeastern provinces of China after many votes and discussions by collecting and collating the information related to off-label drug use in medical institutions from the three northeastern provinces of China，and referring to and citing off-label drug use stated in some expert consensus and medication catalog. RESULTS Finally， a total of 198 pieces of off-label drug use information for 70 drugs were included in the two sections of solid tumors and hematological diseases in Consensus of Experts on Drug Use beyond the Instructions in the Three Provinces of Northeast China. CONCLUSIONS Consensus of Experts on Off-label Drug Use in the Three Northeastern Provinces of Northeast China （solid tumors and hematology）offers a theoretical foundation for rational drug use in the treatment of solid tumors and hematological diseases within medical institutions，and has a positive significance in improving the effectiveness and safety of drug treatment.

Experience With Dexmedetomidine Use in the Treatment of Dysautonomic Crisis in Familial Dysautonomia: An Off-Label Use.

Familial dysautonomia is a rare genetic neurodevelopmental disorder characterized by episodes of hyperautonomic state known as dysautonomic crises. The features of dysautonomic crises are hypertension, tachycardia, vomiting, sweating, flushing, and behavioral changes. The etiology of such crises is supposed to be a consequence of the inability to control sympathetic overflow due to damage to the afferent neurons carrying baroreceptor inputs to the central nervous system. A 19-year-old male with a known history of familial dysautonomia and frequent dysautonomic crises presented to the Emergency Department with intractable nausea and vomiting for six hours. He was hypertensive and tachycardic on presentation. The patient had tried oral labetalol and clonidine at home with no improvement. In the emergency room, the patient received intravenous labetalol, diazepam, and clonidine which were ineffective. He was then treated with intravenous dexmedetomidine, and his symptoms resolved within a few hours. The patient was discharged home on the same day. The mainstay of treatment for dysautonomic crises is benzodiazepines and clonidine. The use of these treatment modalities has its challenges. Here, we present a case of a dysautonomic crisis that was resistant to the conventional treatment, treated safely and successfully with dexmedetomidine.

The Successful Treatment of COVID-19-Induced Bullous Pemphigoid With Dupilumab.

Bullous pemphigoid (BP) is a rare autoimmune blistering condition that predominantly affects the elderly population. Typical treatment regimens target the immune system and inflammatory response. We present a case of BP in a 78-year-old male patient that occurred following the coronavirus disease 2019 (COVID-19) vaccination. This case was refractory to topical steroids and immunosuppressants. However, it responded to treatment with dupilumab, a monoclonal antibody therapy. Dupilumab is classically indicated for the treatment of asthma, eosinophilic esophagitis, atopic dermatitis, and chronic rhinosinusitis with nasal polyposis. We highlight the importance of considering the off-label use of dupilumab and its success in treating BP.

Off-label use of drugs in pediatrics: a scoping review.

To explore the current state of research on off-label drug use in children and identify the existing research gaps in this topic. Six literature databases were searched to identify studies focusing exclusively on off-label drug use in children (aged < 18 years) published in Chinese or English between 2016 and 2021. We also searched clinicaltrials.gov for pediatric clinical trials conducted in the same period and compared the numbers of studies on off-label use and clinical trials for the most commonly reported drugs and drug types. Our search revealed 568 studies on off-label drug use. Almost half of the studies (n = 240) were cross-sectional. A total of 212 specific drugs or drug types were addressed in 361 studies, the most frequent being antipsychotic agents (n = 12), dexmedetomidine (n = 10), and rituximab (n = 8). Antipsychotic agents were also the most common type of drug examined in clinical trials in children. We identified a total of 435 different types of off-label use, the top three being unapproved indication (n = 157), population (n = 96), or age (n = 36). Only about one-third of the studies reported collecting informed consent (n = 195) or having ethics committee approval (n = 166).    Conclusions: Off-label use of antipsychotics in children is widely reported in the literature. We suggest pediatric researchers to consider the number of studies on off-label use and existing clinical trials on different drugs when selecting target drugs for new studies and systematic reviews. What is Known: • There exist a large number of studies on off-label drug use in children. What is New: • This is the first scoping review of studies on off-label drug use in children. • Off-label use of antipsychotic agents is widely reported.

Cumulative Doses Predict the Risk of Furosemide-Induced Electrolyte Abnormalities in Critically Ill Neonates.

Background: Furosemide has limited indications in the term neonates. Its use in preterm neonates is off-label. Considering the dearth of data, we carried out a retrospective study evaluating the furosemide use and its effects on the electrolyte abnormalities in critically ill neonates. Methods: Critically ill neonates receiving at least one dose of furosemide during their stay in the NICU were recruited. The following details were obtained: demographic characteristics and furosemide details (dose, frequency, route, and duration). Urine output, body weight, serum creatinine, electrolytes (sodium, potassium, calcium, bicarbonate, chloride, and magnesium) during furosemide therapy were extracted. Results: Ninety neonates were recruited. Elevated serum creatinine was observed in 21.1% of the patients, and electrolyte disturbances were observed in 52.2%. Those with electrolyte disturbances had significantly greater cumulative doses compared to those without [5.5 (1-34) vs 3.9 (0.9-30.2) mg/kg; p = 0.01]. Cumulative doses adjusted to body-weight were significantly lower in very preterm and extremely preterm neonates compared to late preterm category. A significant area-under-the-curve was observed for the cumulative dose (0.66; 95% CI: 0.54-0.78; p = 0.01) in predicting the risk of electrolyte abnormalities with a cut-off value of 4 mg/kg. Eight neonates received more than 10 mg/kg cumulative dose of furosemide of which one died. No significant differences were observed between the proportion of neonates with electrolyte disturbances with cumulative furosemide dose above 10 mg/kg (p = 0.3) and with mortality (p = 0.3). Conclusion: We observed that our critically ill neonates received relatively higher cumulative doses of furosemide and electrolyte disturbances were observed in nearly half of the population. A cumulative dose of 4 mg/kg increases the risk of electrolyte abnormalities, particularly in preterm neonates. More diligence in the dose titration coupled with deprescribing and intense monitoring of all the potential adverse effects in this vulnerable population is needed.

Drugs Recommended in Adult Rheumatic Diseases, But Considered for Off-Label Use in Argentina.

BACKGROUND: Off-label (OL) drug use is the prescription of a drug for indications other than those authorised in its technical datasheet. The objective of this study was to identify drugs recommended in rheumatology but considered for off-label use in Argentina. METHODS: A list of medications for certain selected rheumatic conditions was compiled. A drug was considered recommended if it was endorsed by a) at least one Argentine or Pan-American treatment guideline or consensus, or b) two international treatment guidelines, or c) one international treatment guideline and one selected textbook. Approval of these drugs for any condition in Argentina until December 31st, 2018 was explored, and medicines were divided into those with on-label indications and those considered for OL use. RESULTS: One hundred and thirty-six medications were analysed in 13 clinical conditions. Sixty-seven OL recommendations (49%) were found, and several drugs had more than one. All the conditions included the recommendation of at least 1 OL drug except osteoporosis and rheumatoid arthritis. The frequency of OL recommendations for the following conditions was 100%: calcium pyrophosphate dihydrate crystal deposition disease, polymyalgia rheumatica, Sjögren syndrome, and systemic sclerosis. The drugs with the highest number of OL recommendations were methotrexate (in 7 conditions), and glucocorticoids and mycophenolate (in 4). There were 2 OL recommendations for rituximab and 1 for abatacept. CONCLUSIONS: Almost all the rheumatic disorders analysed involved the recommendation of at least 1 OL medication, and in 4 conditions all the recommendations were OL. Most OL drugs recommended in rheumatology are neither biological nor small-molecule therapies.

Drugs Recommended in Adult Rheumatic Diseases, But Considered for Off-Label Use in Argentina / Fármacos recomendados en enfermedades reumáticas de adultos, pero considerados al margen de las especificaciones en Argentina

Background: Off-label (OL) drug use is the prescription of a drug for indications other than those authorised in its technical datasheet. The objective of this study was to identify drugs recommended in rheumatology but considered for off-label use in Argentina. Methods: A list of medications for certain selected rheumatic conditions was compiled. A drug was considered recommended if it was endorsed by a) at least one Argentine or Pan-American treatment guideline or consensus, or b) two international treatment guidelines, or c) one international treatment guideline and one selected textbook. Approval of these drugs for any condition in Argentina until December 31st, 2018 was explored, and medicines were divided into those with on-label indications and those considered for OL use. Results: One hundred and thirty-six medications were analysed in 13 clinical conditions. Sixty-seven OL recommendations (49%) were found, and several drugs had more than one. All the conditions included the recommendation of at least 1 OL drug except osteoporosis and rheumatoid arthritis. The frequency of OL recommendations for the following conditions was 100%: calcium pyrophosphate dihydrate crystal deposition disease, polymyalgia rheumatica, Sjögren syndrome, and systemic sclerosis. The drugs with the highest number of OL recommendations were methotrexate (in 7 conditions), and glucocorticoids and mycophenolate (in 4). There were 2 OL recommendations for rituximab and 1 for abatacept. Conclusions: Almost all the rheumatic disorders analysed involved the recommendation of at least 1 OL medication, and in 4 conditions all the recommendations were OL. Most OL drugs recommended in rheumatology are neither biological nor small-molecule therapies.(AU)

Antecedentes: El uso de fármacos al margen de las especificaciones (Off-label) es la prescripción de un fármaco para indicaciones diferentes a las autorizadas en su ficha técnica. El objetivo de este estudio fue identificar los medicamentos recomendados en reumatología, pero considerados al margen de las especificaciones en Argentina. Métodos: Se compiló un listado de medicaciones para determinadas situaciones reumáticas seleccionadas. Se consideró recomendado un fármaco si estaba respaldado por a) al menos una guía o consenso de tratamiento argentino o panamericano, b) por dos guías de tratamiento internacionales, o c) una guía de tratamiento internacional y un manual seleccionado. Se exploró la aprobación de dichos fármacos para cada situación en Argentina hasta el 31 de diciembre del 2018, dividiéndose los medicamentos en aquellos dentro de las especificaciones y los considerados al margen de estas. Resultados: Se analizaron 136 fármacos de 13 situaciones clínicas. Se encontraron 67 recomendaciones al margen de las especificaciones (49%), y alguno de los medicamentos tenían más de una. Todas las situaciones incluyeron al menos un fármaco en estas condiciones, exceptuando osteoporosis y artritis reumatoide. La frecuencia de las recomendaciones al margen de las especificaciones fue del 100%: enfermedad de depósitos de cristales deshidratados de pirofosfato de calcio, polimialgia reumática, síndrome de Sjögren y esclerosis sistémica. Los fármacos con mayor número de estas recomendaciones fueron: metotrexato (en siete situaciones) y glucocorticoides y micofenolato (en cuatro). De igual manera, hubo dos para rituximab y una para abatacept. Conclusiones: Casi todos los trastornos reumáticos analizados implicaron la prescripción de, al menos, un fármaco con recomendaciones al margen de las especificaciones, y en cuatro situaciones todas fueron de este tipo.(AU)

Inpatient Administration of Alpha-1-Adrenergic Receptor Blocking Agents Reduces Mortality in Male COVID-19 Patients.

Apha-1-adrenergic receptor antagonists (α1-blockers) can suppress pro-inflammatory cytokines, thereby potentially improving outcomes among patients with COVID-19. Accordingly, we evaluated the association between α1-blocker exposure (before or during hospitalization) and COVID-19 in-hospital mortality. We identified 2,627 men aged 45 or older who were admitted to Mount Sinai hospitals with COVID-19 between February 24 and May 31, 2020, in New York. Men exposed to α1-blockers (N = 436) were older (median age 73 vs. 64 years, P < 0.001) and more likely to have comorbidities than unexposed men (N = 2,191). Overall, 777 (29.6%) patients died in hospital, and 1,850 (70.4%) were discharged. Notably, we found that α1-blocker exposure was independently associated with improved in-hospital mortality in a multivariable logistic analysis (OR 0.699; 95% CI, 0.498-0.982; P = 0.039) after adjusting for patient demographics, comorbidities, and baseline vitals and labs. The protective effect of α1-blockers was stronger among patients with documented inpatient exposure to α1-blockers (OR 0.624; 95% CI 0.431-0.903; P = 0.012). Finally, age-stratified analyses suggested variable benefit from inpatient α1-blocker across age groups: Age 45-65 OR 0.483, 95% CI 0.216-1.081 (P = 0.077); Age 55-75 OR 0.535, 95% CI 0.323-0.885 (P = 0.015); Age 65-89 OR 0.727, 95% CI 0.484-1.092 (P = 0.124). Taken together, clinical trials to assess the therapeutic value of α1-blockers for COVID-19 complications are warranted.

The Use of Off-Label Medications in Newborn Infants Despite an Approved Alternative Being Available-Results of a National Survey.

Neonates continue to be treated with off-label or unlicensed drugs while in hospital. However, some medications that have previously been used in adults underwent clinical testing and licensure for use with a different indication in the neonatal and pediatric population. Almost always, the marketing of these newly approved substances in a niche indication is accompanied by a steep increase in the price of the compound. We investigated the use of the approved formulation or the cheaper off-label alternative of Ibuprofen (Pedea®), Propanolol (Hemangiol®) and Caffeine Citrate (Peyona®) in neonatal clinical practice by conducting a National Survey of 214 Perinatal Centers in Germany. We also assessed price differences between on- and off-label alternatives and the extend of the clinical development program of the on-label medication in the neonatal population. On-label medication was more frequently used than the off-label alternative in all indications (PDA: on-label to off-label ratio 1:0.26, Apnea: 1:0.56, Hemangioma 1:0.76). All sponsors did conduct placebo-controlled Phase III trials with efficacy and safety endpoints in the target population and the number of participants in the target population varied between 82 and 497. Costs for the three drugs in their approved and marketed formulations increased in median 405-fold compared with the corresponding off-label alternative. Overall, about one out of three neonatologists prescribed an off-label or non-approved drug to patients despite an alternative medication that is approved for the indication in the target population being available.

Real-world data of off-label drug use in patients with actionable genomic alterations on next-generation sequencing.

Introduction We analyzed the outcomes of patients with advanced cancers in our institution treated with off-label drugs targeting actionable genomic alteration based on next-generation sequencing who did not qualify for clinical trials. Purposes Our study endpoint was objective tumor response or stable disease at 16 weeks or later after treatment initiation. Methods Sixteen patients were included, 8 treated with immune checkpoint inhibitors targeting PD-L1 expression or TP53 mutations and 8 with other drugs. Tumors were analyzed based on PD-L1 expression, TP53 mutation, MSI, TMB, MMR status, and other targetable alterations. Results Of the 16 patients in the intention-to-treat group, no patients had an objective response after 16 weeks. Eleven patients met the primary study endpoint with stable disease, 8 in the immune checkpoint inhibitors group and 3 in the non-immune checkpoint inhibitors group. Using the log-rank test, the p-value for the difference between groups was 0.008. Conclusions In this study with off-label drugs, immune checkpoint inhibitors targeting TP53 mutations or PD-L1 expression were superior to the other drugs. This suggests the possibility of off-label use of anti-cancer drugs based on next-generation sequencing to be beneficial for advanced cancer patients without other therapeutic options.

Correlation analysis between the judgment of medical damage liability disputes related to off-label drug use and evidence-based evidence / 中国药房

OBJECTIVE To explore wheth er there is a relationship between the judgment results of medical damage liability disputes related to off-label drug use and evidence-based evidence. METHODS By searching for medical damage liability disputes related to off-label drug use up to 2021 on pkulaw.cn ，documents were extracted to record objective factors ，subjective factors and judgment results ；whether there was evidence-based evidence was judged according to Off-label Drug Use List and Evidence-based Evaluation Standards for Off-label Drug Use of Guangdong Pharmaceutical Association ；univariate analysis was adopted to test the relationship between the judgment results and evidence-based evidence. RESULTS A total of 57 cases were included. Cases mainly occurred in the eastern China （63.2％）and tertiary hospitals （64.9％），the main appraisal agency was the appraisal center or institute（61.4％），and the most common type of off-label drug use was overdose drug use （45.6％）. Among the judgment results ， 23 cases（40.4％）of off-label drug use had a causal relationship with medical damage ，most of the responsibility of doctors was secondary responsibility （28.1％），and the actual compensation amount of the most cases were less than 100，000 yuan（54.4％）. There were 25 cases（43.9％）with evidence-based evidence. Univariate analysis found that for off-label drug use the claim amount of the case with evidence-based evidence was significantly higher than that of the case without evidence-based evidence （P＝ 0.040），and there was no significant correlation between evidence-based evidence and the actual compensation amount of the case （P＝0.741），causality determination （P＝0.256），liability type （P＝0.598）or appraisal agency （P≥0.260）. CONCLUSIONS There is no significant correlation between the judgment results of medical damage liability disputes related to off-label drug use and evidence-based evidence ，indicating that there may be certain differences between judicial trials and medical science. The off-label drug use should be regulated by establishing a complete off-label drug use management system and standardizing informed consent procedure for off-label drug use. 1610307322@pku.edu.cn

Recommendations on off-label antibiotics use in PICU / 中国小儿急救医学

Off-label antibiotics use in pediatric intensive care unit is not rare.Off-label antibiotics use is due to indication, age, dosage, frequency, route and method of administration, course of treatment, etc.It is necessary and reasonable for off-label antibiotics use in clinical practice, but there are also some risks.Off-label antibiotics use in clinical practice should follow the corresponding principles and standardized management.Drug treatment decisions should always be made on the basis that the individual child would be ultimately benefit.

Off-label medication use in rare pediatric diseases in the United States.

Many pediatric patients with rare diseases use drugs off-label due to limited data in pediatric patients. Off-label treatment remains an important public health issue for neonates, infants, children, and adolescents, especially for pediatric patients with rare diseases. For patients with rare diseases, the majority of medications have no or limited information in labelling for pediatric use. Children present unique considerations in clinical trials due to ethical and clinical concerns, which have limited and even discouraged testing of drugs in the pediatric population. Numerous legislative measures have been enacted to address barriers in pediatric drug testing. This research reviewed off-label medication use in rare pediatric diseases, evaluated recent medication uses in pediatric clinical practice, discussed key regulations for rare pediatric diseases, and summarized recent drug approvals for rare pediatric diseases. This study demonstrates the ongoing medical need for newly approved medications to treat pediatric rare diseases and revealed the positive impact of regulations from the Orphan Drug Act of 1983 to the Research to Accelerate Cures and Equity (RACE) for Children Act on drug development and off-label medication practice in rare pediatric disease management. This article provides informative historical background and current considerations of off-label use of medications in neonates, infants, children, and adolescents with rare diseases.

Acid Suppression Use Among Infants in One Tertiary Children's Hospital in China, 2015-2018: A Retrospective Observational Study.

Clinical guidelines emphasized that physicians should be cautious when prescribing acid suppressions to infants. Histamine-2 receptor antagonists (H2RAs) and proton pump inhibitors (PPIs) are not approved for use in infants aged below 2 years in China. We investigated H2RA/PPI use in infants aged below 2 years hospitalized between 1st January 2015 and 31st December 2018 in a Chinese tertiary children's hospital. Our study observed that H2RAs/PPIs were frequently prescribed with a prevalence of 4.4% (7,158/162,192). The frequency of PPI use was over two-fold than that of H2RA use (71.9%, 5,148/7,158; 28.1%, 2,011/7,158). H2RAs/PPIs were commonly used to treat infants without digestive system diseases (57.5%, 4,118/7,158). Further studies are urgently needed to evaluate the effectiveness and safety of H2RAs/PPIs in infants.

Apremilast in the Management of Disseminated Granuloma Annulare.

Granuloma annulare (GA) is a common inflammatory skin condition that manifests as annular skin colored to erythematous papules and plaques. Disseminated GA is a subtype of GA that presents with diffuse cutaneous involvement. While topical and intralesional corticosteroids and phototherapy have been used as therapies for GA, there is no consensus on the best course of treatment for GA. Apremilast is a phosphodiesterase 4 (PDE4) inhibitor that has been Food and Drug Administration (FDA) approved for psoriasis, psoriatic arthritis, and oral ulcers associated with Behcet's disease; apremilast has also shown promise off-label for other inflammatory skin conditions. Here, we present the case of a woman in whom apremilast use led to an almost complete resolution of her disseminated GA. Our patient tolerated apremilast well and reported no side effects. We also review the literature on the use of apremilast in other patients with GA.

Botulinum Toxin Type A injections for pediatric spasticity: Keeping our patients informed and practices safe.

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.