Metoclopramide Hydrochloride

近日，湖北大一女生陶某因注射头孢过敏去世的消息引发热议。4月15日深夜，湖北宜昌大一女生陶某因腹痛和3名同学一起前往宜昌市中心人民医院西陵院区急诊内科就诊，医生曾询问是否有药物过敏，陶兰表示不清楚。急诊病历显示，患者同时伴有发热、心慌表现。经门诊诊断为，腹痛、急性胃肠炎。既往存在左氧氟沙星过敏史。医生根据患者病情，开具相关治疗药物：抗生素类使用注射用头孢曲松钠（第三代头孢菌素），每次静脉点滴2g；止痛药物选用盐酸曲马多注射液，每次肌肉注射100mg；止吐与调节肠胃药物包括盐酸甲氧氯普胺注射液和间苯三酚注射液；此外，还给予包含葡萄糖、生理盐水在内的基础输液及营养补充药物。家属称，陶某的同学后来告知，陶某曾询问医生，使用头孢是否需要皮试，医生回复不需要。媒体梳理了该事件的关键时间线如下：4月15日23:23：陶某开始输液，首袋为其他药物。4月16日00:35：护士换药输注头孢曲松钠后离开。4月16日00:39：陶某出现过敏反应，呼救无医护人员在场，自行拔针后昏迷。4月16日00:41：其他患者发现异常并呼救，医护人员开始抢救，随后被转入ICU治疗。4月20日：陶某因多器官衰竭死亡。事发后，女生家属质疑医院未做皮试，抢救也不及时。医院认为，医生诊断及用药合理，患者的过敏性休克系罕见且严重的不良反应，院方予以积极治疗。5月7日，涉事的宜昌市中心人民医院工作人员告诉记者，针对该事，目前当地卫健委已牵头成立调查小组。双方达成调解协议4月24日，宜昌市医疗纠纷人民调解委员会出具调解协议书。协议书显示，患方认为，医方在对患者使用头孢曲松钠前未行皮试导致患者药物过敏，且在患者出现过敏后抢救不及时导致患者死亡，要求医方承担责任并赔偿。并明确表示协商解决纠纷后放弃通过尸检、医疗损害鉴定或医疗事故鉴定、司法鉴定及法律诉讼等途径维权。医方认为，医务人员对患者的诊断明确，有使用头孢类药物指征，无禁忌症，患者输注头孢曲松钠后出现过敏性休克属于罕见且严重的药物不良反应，在患者出现过敏性休克后医方及时发现并予以积极治疗。最终，双方达成协议。医方向患方一次性补偿包括但不限于死亡赔偿金、丧葬费、精神抚慰金、交通费、住宿费、伙食补助费等所有费用；并承担患方此次住院医保报销后的所有自费部分。指导原则：头孢菌素用药前无需常规进行皮试本次事件的核心争议之一，是头孢菌素类药物是否需要常规皮试。根据2021年国家卫健委发布的《β内酰胺类抗菌药物皮肤试验指导原则》，头孢菌素不推荐常规皮试，仅在以下情况需考虑：1、患者有明确的青霉素或头孢菌素速发型过敏史；2、药品说明书明确要求皮试。该规定与国际主流指南（如美国、欧洲）一致，基于头孢菌素过敏反应发生率低（0.07%-2.8%），且皮试预测价值有限：假阳性率高（10%-30%）导致患者被误判为过敏，被迫使用广谱抗生素，增加耐药风险。而假阴性风险则是无法排除迟发型过敏或杂质致敏。除此之外，《中国药典》和《抗菌药物临床应用指导原则》也均没有头孢菌素类药物进行皮试的规定。尽管指南明确，临床实践中仍存在矛盾，使用头孢曲松钠时要不要皮试，这个问题争议很大，各地并不统一, 说明书和药典中也并无明确规定。临床实际中有不做任何皮试直接使用的，有用青霉素或头孢唑啉代替皮试的，也有原药皮试的。迄今为止，药品说明书对其皮试的要求也是从无到有，最后又从有到无，反反复复。但既往判例显示，法院常从"结果主义"出发裁量责任。2011年北京某医院未对85岁哮喘患者皮试即输注头孢曲松钠，导致患者30秒内呼吸骤停，法院最终以"未尽高度谨慎注意义务"判定医院承担30%责任。撰文 | 梅斯医学编辑 | 阿拉斯加宝● 燃气灶致癌？最新研究：释放一级致癌物，增加患癌风险；仅烹饪1小时，释放的NO2远超阈值，增加死亡率和哮喘发生率！这种方法可缓解●非必要不做CT！最新研究：CT辐射或引发10万例新发癌症；每多做一次CT，血液肿瘤风险升43％；超过该剂量，脑癌风险飙升400％●热议！医生吐槽：退休返聘医生很无能，老眼昏花，电脑不会用！凭啥能拿退休金+医院工资+绩效三重收入？网友建议取消医院返聘，可行吗？版权说明：梅斯医学（MedSci）是国内领先的医学科研与学术服务平台，致力于医疗质量的改进，为临床实践提供智慧、精准的决策支持，让医生与患者受益。欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。点击下方「阅读原文」 立刻下载梅斯医学APP！

SOLANA BEACH, Calif., April 28, 2025 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) disorders with an emphasis on GIMOTI®, today announced that a new abstract comparing the incidence of tardive dyskinesia (TD) in patients receiving continuous versus intermittent oral metoclopramide (OMCP) treatment has been accepted for presentation at Digestive Disease Week® (DDW) 2025, taking place May 3–6, 2025, in San Diego, CA. The analysis leverages real-world data from over 100 million U.S. patients and highlights differences in TD incidence rates and timing based on metoclopramide dosing patterns. “This research builds on our ongoing commitment to understanding metoclopramide’s long-term safety profile,” said Matt D’Onofrio, CEO of Evoke Pharma. “As the only FDA-approved treatment for diabetic gastroparesis, it’s critical that we continue evaluating both efficacy and safety, particularly around concerns like tardive dyskinesia. This real-world data helps clarify risk profiles and supports more informed prescribing decisions for physicians interested in Gimoti. We’re excited to share these findings with the DDW community.” Details of the poster presentation are as follows: Abstract Title: Comparison of the Incidence of Tardive Dyskinesia in Patients Receiving Continuous vs Intermittent Oral Metoclopramide Presenter & Lead Author: Pierantonio Russo, MD, EVERSANA Life Sciences Presentation Session: Gastroparesis and Small Intestinal Dysmotility Date & Time: Monday, May 5, 2025, from 12:30 – 1:30 p.m. PT The abstract will be available via the DDW ePosters site and accessible to attendees through the DDW meeting planner and mobile app after 12:01 a.m. PT on Sunday, May 4, 2025. Visit Evoke Pharma at DDW 2025:To learn more about GIMOTI and our latest research, visit Evoke Pharma at booth #917 during DDW. About Evoke Pharma, Inc. Evoke is a specialty pharmaceutical company focused primarily on the development of drugs to treat GI disorders and diseases. The company developed, commercialized and markets GIMOTI, a nasal spray formulation of metoclopramide, for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adults. Diabetic gastroparesis is a GI disorder affecting millions of patients worldwide, in which the stomach takes too long to empty its contents resulting in serious GI symptoms as well as other systemic complications. The gastric delay caused by gastroparesis can compromise absorption of orally administered medications. Prior to FDA approval to commercially market GIMOTI, metoclopramide was only available in oral and injectable formulations and remains the only drug currently approved in the United States to treat gastroparesis. Visit www.EvokePharma.com for more information. Follow Evoke Pharma on LinkedInFollow Evoke Pharma on Twitter About Digestive Disease Week® (DDW) Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW is an in-person and online meeting from May 3-6, 2025. The meeting showcases nearly 6,000 abstracts and 1,000 invited talks on the latest advances in GI research, medicine, and technology. More information can be found at www.ddw.org. About Gimoti® (metoclopramide) nasal spray GIMOTI is indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis. Important Safety Information WARNING: TARDIVE DYSKINESIA Metoclopramide can cause tardive dyskinesia (TD), a serious movement disorder that is often irreversible. The risk of developing TD increases with duration of treatment and total cumulative dosage.Discontinue GIMOTI in patients who develop signs or symptoms of TD. In some patients, symptoms may lessen or resolve after metoclopramide is stopped.Avoid treatment with metoclopramide (all dosage forms and routes of administration) for longer than 12 weeks because of the increased risk of developing TD with longer-term use. GIMOTI is not recommended for use in: Pediatric patients due to the risk of developing tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates.Moderate or severe hepatic impairment (Child-Pugh B or C), moderate or severe renal impairment (creatinine clearance less than 60 mL/minute), and patients concurrently using strong CYP2D6 inhibitors due to the risk of increased drug exposure and adverse reactions. GIMOTI is contraindicated: In patients with a history of tardive dyskinesia (TD) or a dystonic reaction to metoclopramide.When stimulation of gastrointestinal motility might be dangerous (e.g., in the presence of gastrointestinal hemorrhage mechanical obstruction, or perforation).In patients with pheochromocytoma or other catecholamine-releasing paragangliomas. Metoclopramide may cause a hypertensive/pheochromocytoma crisis, probably due to release of catecholamines from the tumor.In patients with epilepsy. Metoclopramide may increase the frequency and severity of seizures.In patients with hypersensitivity to metoclopramide. Reactions have included laryngeal and glossal angioedema and bronchospasm. Potential adverse reactions associated with metoclopramide include: Tardive dyskinesia (TD), other extrapyramidal effects (EPS), parkinsonism symptoms, motor restlessness, neuroleptic malignant syndrome (NMS), depression, suicidal ideation and suicide, hypertension, fluid retention, hyperprolactinemia, effects on the ability to drive and operate machinery. Most common adverse reactions (≥5%) for GIMOTI are: dysgeusia, headache, and fatigue. These are not all of the possible side effects of GIMOTI. Call your doctor for medical advice about whether you should take GIMOTI and the possible risk factors and side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Safe Harbor Statement Evoke cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should, ”expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negatives of these terms or other similar expressions. These statements are based on the company’s current beliefs and expectations. These forward-looking statements include statements regarding: guidance regarding 2024 net product sales; potential future prescribing trends for GIMOTI based on Evoke’s or EVERSANA’s marketing efforts; Evoke’s commercialization plans, the potential market opportunity for GIMOTI, Evoke’s partnership with ASPN Pharmacies, growth in prescriptions, patients taking GIMOTI and the conversion of prescriptions to fills, and Evoke’s expected cash runway. The inclusion of forward-looking statements should not be regarded as a representation by Evoke that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Evoke’s business, including, without limitation: Evoke may not be able to achieve its guidance for 2024 including as a result of decreased demand for GIMOTI; Evoke’s and EVERSANA’s ability to successfully drive market demand for GIMOTI; Evoke’s ability to obtain additional financing as needed to support its operations; Evoke may use its capital resources sooner than expected; warrant holders may choose not to exercise any of the outstanding warrants; Evoke’s dependence on third parties for the manufacture of GIMOTI; Evoke is entirely dependent on the success of GIMOTI; inadequate efficacy or unexpected adverse side effects relating to GIMOTI that could result in recalls or product liability claims; Evoke’s ability to maintain intellectual property protection for GIMOTI; and other risks and uncertainties detailed in Evoke’s prior press releases and in the periodic reports it files with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Evoke undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investor & Media Contact:Daniel Kontoh-BoatengDKB PartnersTel: 862-213-1398dboateng@dkbpartners.net