Off-label

BACKGROUND CONTEXT: Recombinant human bone morphogenetic protein 2 (rhBMP-2) plays a pivotal role in complex spine surgery. Despite its limited approval, the off-label use of rhBMP-2 is prevalent, particularly in transforaminal lumbar interbody fusions (TLIF) PURPOSE: To determine the effectiveness and safety of rhBMP-2 use in TLIF procedures versus autograft. STUDY DESIGN: Retrospective Cohort Study PATIENT SAMPLE: Patients older than 18 years undergoing spine surgery for lumbar degenerative spine disease at a single academic institution...

To systematically evaluate the safety of Kudiezi injection. Databases such as Cochrane library, Medline, EMbase, Web of Science, Clinical Trials, CBM, CNKI, VIP, Wanfang and Chinese Clinical Trial Register were searched to collect the literature on all the study types of Kudiezi injection. Two researchers screened literature, assessed quality and extracted data according to inclusion and exclusion criteria. All studies were assessed by using internationally recognized methodological quality assessment tools or reporting quality evaluation criteria; Meta-analysis of adverse drug reaction/adverse events (ADR/AE) of Kudiezi injection was performed by using Stata 12...

STUDY DESIGN: Retrospective database review. OBJECTIVE: To analyze and report the trends and cost of posterior cervical fusions (PCFs) with and without off-label recombinant human bone morphogenetic protein-2 (rhBMP-2) in the Medicare population. METHODS: Patient records from the PearlDiver database were retrospectively reviewed from January 1, 2005, to December 31, 2012, to distinguish individuals who underwent a PCF with or without rhBMP-2...

One of the most pressing contemporary health care challenges consists in rethinking antibiotic use to contrast the increase of multidrug resistant bacteria. Drawing on an ethnographic fieldwork in an Intensive Care Unit that adopts a nonconforming policy of antibiotic stewardship, this article analyzes doctor-doctor interaction concerning infectious disease diagnosis and antibiotic treatment. By analyzing examples of medical decision-making from a corpus of video-recorded morning briefings, we focus on physicians' stance-taking toward the ward's nonconforming policy and illustrate how it is contingently situated along a continuum from strong commitment to overt resistance...

BACKGROUND AND OBJECTIVE: Chronic Low Back Pain (CLBP) is very common, with a lifetime prevalence between 51% and 80%. In majority, it is nonspecific in nature and multifactorial in etiology. Pregabalin (PG) and Gabapentin (GB) are gabapentinoids that have demonstrated benefit in neuropathic pain conditions. Despite no clear rationale, they are increasingly used for nonspecific CLBP. They necessitate prolonged use and are associated with adverse effects and increased cost. Recent guidelines from the National Health Service (NHS), England, expressed concerns on their off-label use, in addition to the risk of misuse...

Ursodeoxycholic acid is the first-line therapy for primary biliary cholangitis. However, a subset of patients fail to show biochemical response. For these patients, adjuvant therapies are warranted. Obeticholic acid was conditionally approved as a second-line drug. Evidence is building up in favor of fibrates, which are available for off-label use.

Bone morphogenetic proteins are osteoinductive factors which have gained popularity in orthopaedic surgery and especially in spine surgery. The use of recombinant human bone morphogenetic protein-2 has been officially approved by the United States Food and Drug Administration only for single level anterior lumbar interbody fusion, nevertheless it is widely used by many surgeons with off-label indications. Despite advantages in bone formation, its use still remains a controversial issue and several complications have been described by authors who oppose their wide use...

BACKGROUND The treatment of locally advanced non-small cell lung cancer involves a combination of chemotherapy, surgery, and radiotherapy. Each case is discussed and the best strategy is chosen individually, following international guidelines. CASE REPORT A 37-year-old man was diagnosed with locally advanced broncho-pulmonary adenocarcinoma (stage IIIA). The disease was stable after 2 cycles of cisplatin plus Navelbine used as neoadjuvant therapy. FISH analysis revealed an ALK rearrangement. The patient then received unlicensed crizotinib as second-line neoadjuvant treatment, which led to an almost complete radiological and metabolic response...

Drooling of saliva is common in children with physical, intellectual and learning disability, and with poor neuromuscular coordination and oral control.(1) It can cause skin breakdown, damage to clothes and equipment and psychosocial problems for the child and family. For many years, glycopyrronium has been prescribed off-label using the injection solution given orally or tablets crushed and suspended in water, or as unlicensed products that were imported or manufactured as pharmaceutical specials.(2,3) In January 2017, a glycopyrronium oral solution (Sialanar-Proveca Limited) became available in the UK as the first licensed product for the treatment of severe drooling (sialorrhoea) in children and adolescents aged 3 years and older with chronic neurological disorders...

Non-invasive genomic profiling of tumors may be possible with next-generation sequencing (NGS) of blood-derived circulating tumor DNA (ctDNA), but proof of concept in a large cohort <p>of patients with diverse cancers has yet to be reported. Here we report the results of an analysis of plasma-derived ctDNA from 670 patients with diverse cancers.</p> The tumors represented in the patient cohort were mainly gastrointestinal (31.8%), brain (22.7%) or lung (20.7%). ctDNA obtained from most patients (N = 423 (63%)) displayed at least 1 alteration...

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BACKGROUND: An omalizumab treatment and a high maintenance venom dose may both help to prevent recurrent systemic allergic reactions (SAR) to venom immunotherapy (VIT). The effectiveness of this combination therapy, however, is unclear. OBJECTIVE: We wanted to explore the possibility whether a temporary treatment with the anti-IgE antibody omalizumab, combined with a VIT using an elevated maintenance dose of >100 μg venom may establish a permanent tolerance of maintenance VIT...

BACKGROUND: Apixaban is a direct oral anticoagulant (DOAC) for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF). Other DOACs require renal dose adjustments based solely on creatinine clearance. Apixaban differs in that its dose adjustments are more complex, potentially leading to prescribing errors. OBJECTIVE: To determine if adherence to Food and Drug Administration (FDA)-approved dosing for apixaban is maintained in hospitalized patients with NVAF...

The lawsuits with antineoplastic drugs generate high costs for governments and require careful analysis to ensure efficient and adequate health results. This study analyzed cases conducted by federal entities to a reference institute for the treatment of cancer for technical opinion. Data were collected from copies of the cases examined from July 1 to December 31, 2013. It was analyzed: therapeutic subgroups, presence in essential drug list, drug registry, off-label use, indications of clinical practice guidelines, drug incorporation in Brazilian Health System and estimated value of court cases...

OBJECTIVE: Optimal pain management often requires multiple pharmacological interventions with the goal of disrupting the pain-signaling pathway and targeting the underlying pathophysiology. Off label use of nonpain medications may have a role in treating refractory pain syndromes. BACKGROUND: We report a case of a 60-year-old female with refractory nociceptive and neuropathic pain. Conventional therapies were either ineffective or fraught with side effects. Given the underlying inflammatory nature of her pain syndrome, and the role of substance P (SP) in pain transmission and modulation, we decided to use fosaprepitant, an SP and neurokinin-1 (NK1) receptor antagonist...

This case report aims to describe in detail a complication associated with resorption of regenerated bone following implant placement and ridge augmentation using rhBMP-2 in combination with allograft and xenograft. Bilateral maxillary sinus and ridge augmentation procedures were completed using rhBMP-2 combined with allograft and xenograft. Five months later, significant bone augmentation was achieved which allowed for the placement of 4 implants. Upon stage 2 surgery, significant dehiscence was noted in all implants...

INTRODUCTION: The peripherally inserted central catheters (PICCs) are vascular access devices (VAD) that are increasingly being used in the pediatric population. If a small vein caliber prevents positioning the catheter in the arm, the following step is to position the same catheter in the supraclavicular area, which can be defined as an off-label use or "atypical" approach, first described by Pittiruti. MATERIALS AND METHODS: We retrospectively reviewed PICC positioning with puncture-site in the supra-clavicular area ("atypical" PICC insertion) and then tunneled on the chest...

Neurofibromatosis type 2 (NF2) is a nervous system tumor disorder caused by inactivation of the merlin tumor suppressor encoded by the NF2 gene. Bilateral vestibular schwannomas (VS) are a diagnostic hallmark of NF2. Mainstream treatment options for NF2-associated tumors have been limited to surgery and radiotherapy; however, off-label uses of targeted molecular therapies are becoming increasingly common. Here we investigated drugs targeting two kinases activated in NF2-associated schwannomas, c-Met and Src...

The wake-promoting drug modafinil is frequently used off-label to improve cognition in psychiatric and academic populations alike. The domain-specific attentional benefits of modafinil have yet to be quantified objectively in healthy human volunteers using tasks validated for comparison across species. Further, given that modafinil is a low-affinity inhibitor for the dopamine and norepinephrine transporters (DAT/NET respectively) it is unclear if any effects are attributable to a non-specific increase in arousal, a feature of many catecholamine reuptake inhibitors (e...

Seizures are common in neonates with moderate and severe hypoxic ischemic encephalopathy (HIE) and are associated with worse outcomes, independent of HIE severity. In contrast to adults and older children, no new drugs have been licensed for treatment of neonatal seizures over the last 50 years, because of a lack of controlled clinical trials. Hence, many antiseizure medications licensed in older children and adults are used off-label for neonatal seizure, which is associated with potential risks of adverse effects during a period when the brain is particularly vulnerable...