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aspirin and Reye syndrome

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1. Clopidogrel/Acetylsalicylic acid Teva

2.5. Clinical safety 30 2.6. Pharmacovigilance 33 2.7. Risk Management Plan 34 2.8. Product information 39 3. Benefit-Risk Balance 39 Benefit-risk balance 41 4. Recommendations 42 Medicinal product no longer authorised Assessment report EMA/502333/2014 Page 3/43 List of abbreviations AA Arachidonic acid ACE Angiotensin converting enzyme ACS Acute coronary syndrome ADP Adenosine diphosphate AE Adverse event Al(u) Aluminium ANOVA Analysis of variance ASA Acetylsalicylic acid AUC Area under the curve (...) procedure under Article 3(2)(b) of Regulation (EC) No 726/2004 was based on demonstration of interest of patients at Community level. The applicant applied for the following indication : Clopidogrel/Acetylsalicylic acid Teva is indicated for the prevention of atherothrombotic events in adult patients already taking both clopidogrel and acetylsalicylic acid (ASA). Fixed-dose combination medicinal product for continuation of therapy in: • Non ST segment elevation acute coronary syndrome (unstable angina

2014 European Medicines Agency - EPARs

2. Reye's syndrome

. Prognosis is generally good, and liver function returns to normal. However, encephalopathy can result in permanent neurological sequelae. Definition Reye's syndrome is an illness that meets all of the following criteria: Centers for Disease Control and Prevention. Reye syndrome: 1990 clinical case definition. 1990 [internet publication]. http://wwwn.cdc.gov/nndss/conditions/reye-syndrome/case-definition/1990/ an acute, non-inflammatory encephalopathy with either sterile CSF containing <9 WBC/mL (...) Reye's syndrome Reye's syndrome - Symptoms, diagnosis and treatment | BMJ Best Practice You'll need a subscription to access all of BMJ Best Practice Search  Reye's syndrome Last reviewed: February 2019 Last updated: March 2018 Summary An acute encephalopathy with hepatic dysfunction stemming from mitochondrial damage. Aetiology remains unknown, but viral infections, exogenous toxins, drugs, and inborn errors of metabolism have been implicated. Aspirin is classically associated but data

2018 BMJ Best Practice

3. DuoPlavin - clopidogrel / acetylsalicylic acid

, acidic, basic and oxidative conditions. Results indicate that the active substance obtained from Synthesis Routes 1 and 2 is stable when stored according to proposed conditions and confirmed the re-test period. Acetylsalicylic acid (ASA) Acetylsalicylic acid is chemically designated as Benzoic acid, 2-(acetyloxy) (CAS) or 2-(acetyloxy)- benzoic acid (IUPAC). It is also commonly known as Aspirin and has the following structure: O OH O O It is white crystalline powder with melting point at 156 - 161 °C (...) for the following indication: DuoPlavin is indicated for the prevention of atherothrombotic events in adult patients already taking both clopidogrel and acetylsalicylic acid (ASA). DuoPlavin is a fixed-dose combination product for continuation of therapy in: ? Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction) including patients undergoing a stent placement following percutaneous coronary intervention ? ST segment elevation acute myocardial infarction

2010 European Medicines Agency - EPARs

4. DuoCover - clopidogrel / acetylsalicylic acid

and oxidative conditions. Results indicate that the active substance obtained from Synthesis Routes 1 and 2 is stable when stored according to proposed conditions and confirmed the re-test period. Acetylsalicylic acid (ASA) Acetylsalicylic acid is chemically designated as Benzoic acid, 2-(acetyloxy) (CAS) or 2-(acetyloxy)- benzoic acid (IUPAC). It is also commonly known as Aspirin and has the following structure: O OH O O It is white crystalline powder with melting point at 156 - 161 °C, freely soluble (...) indication: DuoCover is indicated for the prevention of atherothrombotic events in adult patients already taking both clopidogrel and acetylsalicylic acid (ASA). DuoCover is a fixed-dose combination product for continuation of therapy in: ? Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction) including patients undergoing a stent placement following percutaneous coronary intervention ? ST segment elevation acute myocardial infarction in medically treated

2010 European Medicines Agency - EPARs

5. Acetylsalicylic acid as a potential pediatric health hazard: legislative aspects concerning accidental intoxications in the European Union Full Text available with Trip Pro

Acetylsalicylic acid as a potential pediatric health hazard: legislative aspects concerning accidental intoxications in the European Union Acetylsalicylic acid is a frequently used medication worldwide. It is not used in pediatrics due its association with Reye syndrome. However, in case of pediatric intoxication, children are more fragile to salicylate poisoning because of their reduced ability of buffer the acid stress. Intoxication leads to a decoupling of oxidative phosphorylation (...) and subsequently to a loss in mitochondrial function. Symptoms of poisoning are diverse; eventually they can lead to the death of the patient. Governmental websites of various EU countries were searched for legal information on acetylsalicylic acid availability in pharmacies and non-pharmacy stores. Various EU countries permit prescription-free sales of acetylsalicylic acid in pharmacies and non-pharmacy stores. In Sweden acetylsalicylic acid 500 mg may be sold in a maximum package size of 20 tablets

2016 Journal of occupational medicine and toxicology (London, England)

6. Reye's Syndrome

, it can also occur in the absence of aspirin use. Definition (NCI_NCI-GLOSS) A rare disease that damages the brain and liver and causes death if not treated. It occurs most often in children younger than 15 years who have had a fever-causing virus, such as chickenpox or flu. Taking aspirin during a viral illness may increase the risk of Reye syndrome. Definition (MSH) A form of encephalopathy with fatty infiltration of the LIVER, characterized by brain EDEMA and VOMITING that may rapidly progress (...) Delirium Convulsions Loss of consciousness If these symptoms occur soon after a viral illness, seek medical attention immediately. Reye syndrome can lead to a coma and brain death, so quick diagnosis and treatment are critical. Treatment focuses on preventing brain damage. There is no cure. The cause of Reye syndrome is unknown. Studies have shown that taking aspirin increases the risk of getting it. Because of that, health care professionals now recommend other pain relievers for young patients. NIH

2018 FP Notebook

7. Low-Dose Aspirin Use During Pregnancy

bronchospasm (27). Relative con- traindications to low-dose aspirin include a history of gastrointestinal bleeding, active peptic ulcer disease, other sources of gastrointestinal or genitourinary bleed- ing, and severe hepatic dysfunction. Reye syndrome has been reported rarely (less than 1%) in children younger than 18 years who are given aspirin while recovering from viral illnesses, particularly influenza and chicken- pox. The decision to continue low-dose aspirin in the presence of obstetric bleeding (...) ). Pathophysiology Aspirin (acetylsalicylic acid) is a nonsteroidal antiin- flammatory drug (NSAID) that works primarily through its inhibition of two cyclooxygenase isoen- zymes (COX-1 and COX-2), which are necessary for prostaglandin biosynthesis. The COX-1 isoform is present in the vascular endothelium and regulates the production of prostacyclin and thromboxane A 2 , pros- taglandins with opposing regulatory effects on vascular homeostasis and platelet function. Prostacyclin is a potent vasodilator

2018 American College of Obstetricians and Gynecologists

8. Low-Dose Aspirin Use During Pregnancy

bronchospasm (27). Relative con- traindications to low-dose aspirin include a history of gastrointestinal bleeding, active peptic ulcer disease, other sources of gastrointestinal or genitourinary bleed- ing, and severe hepatic dysfunction. Reye syndrome has been reported rarely (less than 1%) in children younger than 18 years who are given aspirin while recovering from viral illnesses, particularly influenza and chicken- pox. The decision to continue low-dose aspirin in the presence of obstetric bleeding (...) ). Pathophysiology Aspirin (acetylsalicylic acid) is a nonsteroidal antiin- flammatory drug (NSAID) that works primarily through its inhibition of two cyclooxygenase isoen- zymes (COX-1 and COX-2), which are necessary for prostaglandin biosynthesis. The COX-1 isoform is present in the vascular endothelium and regulates the production of prostacyclin and thromboxane A 2 , pros- taglandins with opposing regulatory effects on vascular homeostasis and platelet function. Prostacyclin is a potent vasodilator

2018 American College of Obstetricians and Gynecologists

9. Pediatrics, Reye Syndrome (Treatment)

of therapy (eg, Kawasaki disease). Of approximately 200,000 children in Japan who were treated with aspirin for Kawasaki disease, only 1 was reported to have developed Reye syndrome. In children who require long-term salicylate therapy, use of these agents should be discontinued immediately at the first signs or symptoms of Reye syndrome. It is critical to be alert for and recognize early symptoms of Reye syndrome. It is also important to be mindful of the possibility that an IEM may be the actual cause (...) Funct . 2008 Oct. 26 (7):741-6. . REYE RD, MORGAN G, BARAL J. ENCEPHALOPATHY AND FATTY DEGENERATION OF THE VISCERA. A DISEASE ENTITY IN CHILDHOOD. Lancet . 1963 Oct 12. 2 (7311):749-52. . Uppala R, Dudiak B, Beck ME, Bharathi SS, Zhang Y, Stolz DB, et al. Aspirin increases mitochondrial fatty acid oxidation. Biochem Biophys Res Commun . 2017 Jan 8. 482 (2):346-351. . Singh P, Goraya JS, Gupta K, Saggar K, Ahluwalia A. Magnetic resonance imaging findings in Reye syndrome: case report and review

2014 eMedicine Emergency Medicine

10. Pediatrics, Reye Syndrome (Diagnosis)

States, Reye syndrome became a reportable disease in 1973. Peak incidence was reported in 1979-80. [ , , ] Reye syndrome typically occurs after a viral illness, particularly an upper respiratory tract infection, , , or , and is associated with the use of aspirin during the illness. A dramatic decrease in the use of aspirin among children, in combination with the identification of medication reactions, toxins, and (IEMs) that present with Reye syndrome–like manifestations, have made the diagnosis (...) after diagnostic workup should be referred to as Reye disease. Next: Pathophysiology The pathogenesis of Reye syndrome, while not precisely elucidated, appears to involve mitochondrial injury resulting in dysfunction that disrupts oxidative phosphorylation and fatty-acid beta-oxidation in a virus-infected, sensitized host potentially with an underlying occult inborn error of fatty acid oxidation, urea cycle or mitochondrial disorder. [ , ] The host has usually been exposed to mitochondrial toxins

2014 eMedicine Emergency Medicine

11. Pediatrics, Reye Syndrome (Follow-up)

of therapy (eg, Kawasaki disease). Of approximately 200,000 children in Japan who were treated with aspirin for Kawasaki disease, only 1 was reported to have developed Reye syndrome. In children who require long-term salicylate therapy, use of these agents should be discontinued immediately at the first signs or symptoms of Reye syndrome. It is critical to be alert for and recognize early symptoms of Reye syndrome. It is also important to be mindful of the possibility that an IEM may be the actual cause (...) Funct . 2008 Oct. 26 (7):741-6. . REYE RD, MORGAN G, BARAL J. ENCEPHALOPATHY AND FATTY DEGENERATION OF THE VISCERA. A DISEASE ENTITY IN CHILDHOOD. Lancet . 1963 Oct 12. 2 (7311):749-52. . Uppala R, Dudiak B, Beck ME, Bharathi SS, Zhang Y, Stolz DB, et al. Aspirin increases mitochondrial fatty acid oxidation. Biochem Biophys Res Commun . 2017 Jan 8. 482 (2):346-351. . Singh P, Goraya JS, Gupta K, Saggar K, Ahluwalia A. Magnetic resonance imaging findings in Reye syndrome: case report and review

2014 eMedicine Emergency Medicine

12. Pediatrics, Reye Syndrome (Overview)

States, Reye syndrome became a reportable disease in 1973. Peak incidence was reported in 1979-80. [ , , ] Reye syndrome typically occurs after a viral illness, particularly an upper respiratory tract infection, , , or , and is associated with the use of aspirin during the illness. A dramatic decrease in the use of aspirin among children, in combination with the identification of medication reactions, toxins, and (IEMs) that present with Reye syndrome–like manifestations, have made the diagnosis (...) after diagnostic workup should be referred to as Reye disease. Next: Pathophysiology The pathogenesis of Reye syndrome, while not precisely elucidated, appears to involve mitochondrial injury resulting in dysfunction that disrupts oxidative phosphorylation and fatty-acid beta-oxidation in a virus-infected, sensitized host potentially with an underlying occult inborn error of fatty acid oxidation, urea cycle or mitochondrial disorder. [ , ] The host has usually been exposed to mitochondrial toxins

2014 eMedicine Emergency Medicine

13. Linking Drugs to Obscure Illnesses: Lessons from Pure Red Cell Aplasia, Nephrogenic Systemic Fibrosis, and Reye's Syndrome. A Report From the Southern Network on Adverse Reactions (SONAR). Full Text available with Trip Pro

Linking Drugs to Obscure Illnesses: Lessons from Pure Red Cell Aplasia, Nephrogenic Systemic Fibrosis, and Reye's Syndrome. A Report From the Southern Network on Adverse Reactions (SONAR). Identification of serious adverse drug reactions (sADRS) associated with commonly used drugs can elude detection for years. Reye's syndrome (RS), nephrogenic systemic fibrosis (NSF), and pure red cell aplasia (PRCA) among chronic kidney disease (CKD) patients were recognized in 1951, 2000, and 1998 (...) , respectively. Reports associating these syndromes with aspirin, gadodiamide, and epoetin, were published 29, 6, and 4 years later, respectively. We obtained primary information from clinicians who identified causes of these sADRs and reviewed factors contributing to delayed identification of these toxicities. Overall, 3,500 aspirin-associated RS cases in the United States, 1,605 gadolinium-associated NSF cases, and 181 epoetin-associated PRCA cases were reported. Delays in FDA regulation of over

2012 Journal of General Internal Medicine

14. Reye's Syndrome

, it can also occur in the absence of aspirin use. Definition (NCI_NCI-GLOSS) A rare disease that damages the brain and liver and causes death if not treated. It occurs most often in children younger than 15 years who have had a fever-causing virus, such as chickenpox or flu. Taking aspirin during a viral illness may increase the risk of Reye syndrome. Definition (MSH) A form of encephalopathy with fatty infiltration of the LIVER, characterized by brain EDEMA and VOMITING that may rapidly progress (...) Delirium Convulsions Loss of consciousness If these symptoms occur soon after a viral illness, seek medical attention immediately. Reye syndrome can lead to a coma and brain death, so quick diagnosis and treatment are critical. Treatment focuses on preventing brain damage. There is no cure. The cause of Reye syndrome is unknown. Studies have shown that taking aspirin increases the risk of getting it. Because of that, health care professionals now recommend other pain relievers for young patients. NIH

2015 FP Notebook

15. Cardiovascular Disease: Tailored Pharmacy-based Interventions to Improve Medication Adherence

disease).mp. 36. (thromboembolic disease or congestive heart failure or atherosclerosis).mp. 37. or/28-36 38. 8 and 21 and 22 and 27 39. 7 and 21 and 22 and 27 and 37 40. limit 38 to english language 41. limit 39 to english language 42. 40 or 41 Database: Scopus #1 TITLE-ABS-KEY ( "Hypertension" OR "Blood Pressure" OR "Cholesterol" OR " hypercholesterol*” OR "aspirin" OR “acetylsalicylic acid” or “ASA” OR "high lipid levels" OR "high level lipids" OR "blood fat" OR "blood fats" OR "blood lipid (...) . Search Strategy – Effectiveness Review Database: PubMed #1 "Hypertension"[Mesh] OR "Blood Pressure"[Mesh] OR "Hypercholesterolemia"[Mesh] OR "Cholesterol"[Mesh] OR "Aspirin"[Mesh] OR "hypertension"[Title/Abstract] OR "blood pressure"[Title/Abstract] OR "cholesterol"[Title/Abstract] OR "hypercholesterol"[Title/Abstract] OR "hypercholesterolemia"[Title/Abstract] OR “acetylsalicylic acid”[Title/Abstract] or “ASA”[Title/Abstract] OR “aspirin"[Title/Abstract] OR "high blood pressure" OR "high cholesterol

2020 Community Preventive Services Task Force

16. Aspirin as an add-on Treatment of Refractory Epilepsy in Tuberous Sclerosis Complex

System Diseases Nervous System Diseases Cognition Disorders Neurocognitive Disorders Mental Disorders Hamartoma Neoplasms Neoplasms, Multiple Primary Neoplastic Syndromes, Hereditary Malformations of Cortical Development, Group I Malformations of Cortical Development Nervous System Malformations Neurocutaneous Syndromes Heredodegenerative Disorders, Nervous System Neurodegenerative Diseases Congenital Abnormalities Genetic Diseases, Inborn Aspirin Anti-Inflammatory Agents, Non-Steroidal Analgesics (...) in the treatment of tuberous sclerosis complex (TSC) in one child who got Kawasaki disease and in the addition four TSC patients with epilepsy. The investigator intend to evaluate whether aspirin would be an effective add-on treatment in TSC patients with refractory seizures. Condition or disease Intervention/treatment Phase Tuberous Sclerosis Complex Aspirin Epilepsy Cognitive Decline Skin Lesions Drug: Aspirin Drug: AED Drug: Placebo Phase 2 Detailed Description: There is no optional treatment for patients

2017 Clinical Trials

17. Defining Oligometastatic Disease from a Radiation Oncology Perspective

treatment of the primary cancer and all metastatic lesions might have a curative potential [19,21,25,29,32,34,38,51,57,58,61,64,65,73– 75,78,83,87,92,99,100,104–111] + Outcome An intermediate state in which local or treated metastasis control may yield improved systemic control [39,66] + Disease burden Limited number of metastases:oligometastatic is de?ned asa small number of low volume metastases, 5 orless, 3 or less [22,23,35,42,45,70,112–114] Limited number of sites/regions [31,71] Single or limited (...) Defining Oligometastatic Disease from a Radiation Oncology Perspective Original Article De?ning oligometastatic disease from a radiation oncology perspective: An ESTRO-ASTRO consensus document Yolande Lievens a,? , Matthias Guckenberger b , Daniel Gomez c , Morten Hoyer d , Puneeth Iyengar e , Isabelle Kindts f , Alejandra Méndez Romero g , Daan Nevens h , David Palma i , Catherine Park j , Umberto Ricardi k , Marta Scorsetti l , James Yu m , Wendy A. Woodward c a Department of Radiation

2020 American Society for Radiation Oncology

18. American College of Rheumatology Guideline for the Management of Reproductive Health in Rheumatic and Musculoskeletal Diseases

or persistent positive lupus anticoagulant); APS = antiphospholipid syndrome (obstetric and/or thrombotic); obstetric APS (OB APS) = patients meeting laboratory criteria for APS and having prior consistent pregnancy complications (=3 consecutive losses prior to 10 weeks’ gestation, fetal loss at or after 10 weeks’ gestation, or delivery at 100 mg per day. Low- dose aspirin is not thought to complicate anesthesia or delivery (112); however, a decision regarding discontinuation prior to delivery should (...) acid 5 mg/day ? Limited data suggest low transfer Leflunomide ?? Cholestyramine washout if detectable levels ?? Stop and give cholestyramine washout ?? Mycophenolate mofetil andmycophenolic acid ?? Stop >6 weeks prior to conception to assess disease stability ?? ?? Cyclophosphamide ?? Stop 3 months prior to conception + Life-/organ-threatening disease in second and third trimesters ?? Thalidomide ?? Stop 1–3 months prior to conception ?? ?? Tofacitinib, apremilast, baricitinib Unable to determine

2020 American College of Rheumatology

19. Management of Cardiovascular Diseases during Pregnancy Full Text available with Trip Pro

, maternal heart disease is the major cause of maternal death during pregnancy. , Hypertensive disorders are the most frequent cardiovascular disorders during pregnancy, occurring in 5–10% of all pregnancies (see section 10). Among the other disease conditions, congenital heart disease is the most frequent CVD present during pregnancy in the western world (75–82%). , Rheumatic valvular disease dominates in non-western countries, comprising 56–89% of all CVDs in pregnancy. , Peripartum intensive care unit (...) ventricle with good or mildly decreased ventricular function Fontan circulation. If otherwise the patient is well and the cardiac condition uncomplicated Unrepaired cyanotic heart disease Other complex heart disease Moderate mitral stenosis Severe asymptomatic aortic stenosis Moderate aortic dilatation (40–45 mm in Marfan syndrome or other HTAD; 45–50 mm in bicuspid aortic valve, Turner syndrome ASI 20–25 mm/m 2 , tetralogy of Fallot <50 mm) Ventricular tachycardia Pulmonary arterial hypertension Severe

2018 European Society of Cardiology

20. Which Kind of Baby Aspirin Should I Take To Prevent Heart Attack? Chewable Versus Enteric Coated Versus Regular

she was at the local Walgreen’s. Aspirin or acetyl salicylic acid (ASA) comes in either a 325 mg dose or in a low dose which can be between 75 to 100 mg and is often called “baby” aspirin. However, since a link between aspirin use and a potentially lethal disease called Reye’s syndrome was identified in the 1980s, no authorities recommend aspirin in children or babies, and the low dose ASA (LDASA) is primarily marketed and used for prevention of cardiovascular disease. Although Bayer and Dr. Oz (...) I will be swallowing daily the orange chewable LDASA and I will carry a bottle around in my satchel for emergency use. Salicylically Yours, -ACP N.B. Aspirin is generally recommended in secondary prevention of cardiovascular disease, ie. for those who have had heart attacks, stents or bypass surgery . For a good review of the evidence for this see . Share this: Like this: Like Loading... Related Post navigation 9 thoughts on “Which Kind of Baby Aspirin Should I Take To Prevent Heart Attack

2018 The Skeptical Cardiologist

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