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Adverse Event Attributed to Commercial Product

MedGen UID:
1716883
•Concept ID:
C5237829
•
Finding

Definition

An indication that an adverse event is causally related to the use of a commercially available product. [from NCI]

Term Hierarchy

CClinical test,  RResearch test,  OOMIM,  GGeneReviews,  VClinVar  
  • CROGVAdverse Event Attributed to Commercial Product

Professional guidelines

PubMed

Financial Implications of Avapritinib for Treatment of Unresectable Gastrointestinal Stromal Tumors in Patients With a PDGFRA Exon 18 Variant or After 3 Previous Therapies in a Hypothetical US Health Plan.
Proudman D, Miller A, Nellesen D, Gomes A, Mankoski R, Norregaard C, Sullivan E
JAMA Netw Open 2020 Nov 2;3(11):e2025866. doi: 10.1001/jamanetworkopen.2020.25866. PMID: 33201235Free PMC Article
Preferences of Patients and Pharmacists with Regard to the Management of Drug-Drug Interactions: A Choice-Based Conjoint Analysis.
Heringa M, Floor-Schreudering A, Wouters H, De Smet PAGM, Bouvy ML
Drug Saf 2018 Feb;41(2):179-189. doi: 10.1007/s40264-017-0601-7. PMID: 28965265Free PMC Article
Management of pressure ulcers.
Cannon BC, Cannon JP
Am J Health Syst Pharm 2004 Sep 15;61(18):1895-905; quiz 1906-7. PMID: 15487879

Recent clinical studies

Etiology

The Bowtie diagram: a simple tool for analysis and planning in anesthesia.
Culwick MD, Endlich Y, Prineas SN
Curr Opin Anaesthesiol 2020 Dec;33(6):808-814. doi: 10.1097/ACO.0000000000000926. PMID: 33044235Free PMC Article
SGLT2 Inhibitors: A Review of Their Antidiabetic and Cardioprotective Effects.
Tentolouris A, Vlachakis P, Tzeravini E, Eleftheriadou I, Tentolouris N
Int J Environ Res Public Health 2019 Aug 17;16(16) doi: 10.3390/ijerph16162965. PMID: 31426529Free PMC Article
Energy Drinks Induce Acute Cardiovascular and Metabolic Changes Pointing to Potential Risks for Young Adults: A Randomized Controlled Trial.
Basrai M, Schweinlin A, Menzel J, Mielke H, Weikert C, Dusemund B, Putze K, Watzl B, Lampen A, Bischoff SC
J Nutr 2019 Mar 1;149(3):441-450. doi: 10.1093/jn/nxy303. PMID: 30805607
Safety With Echocardiographic Contrast Agents.
Muskula PR, Main ML
Circ Cardiovasc Imaging 2017 Apr;10(4) doi: 10.1161/CIRCIMAGING.116.005459. PMID: 28377467
Heart disease and stroke statistics--2011 update: a report from the American Heart Association.
Roger VL, Go AS, Lloyd-Jones DM, Adams RJ, Berry JD, Brown TM, Carnethon MR, Dai S, de Simone G, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Greenlund KJ, Hailpern SM, Heit JA, Ho PM, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, McDermott MM, Meigs JB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Rosamond WD, Sorlie PD, Stafford RS, Turan TN, Turner MB, Wong ND, Wylie-Rosett J; American Heart Association Statistics Committee and Stroke Statistics Subcommittee
Circulation 2011 Feb 1;123(4):e18-e209. Epub 2010 Dec 15 doi: 10.1161/CIR.0b013e3182009701. PMID: 21160056Free PMC Article

Diagnosis

Immune checkpoint inhibitors: immune-related adverse events, healthcare utilization, and costs among commercial and Medicare Advantage patients.
Gunturu KS, Pham TT, Shambhu S, Fisch MJ, Barron JJ, Debono D
Support Care Cancer 2022 May;30(5):4019-4026. Epub 2022 Jan 21 doi: 10.1007/s00520-022-06826-9. PMID: 35064328Free PMC Article
Energy Drinks Induce Acute Cardiovascular and Metabolic Changes Pointing to Potential Risks for Young Adults: A Randomized Controlled Trial.
Basrai M, Schweinlin A, Menzel J, Mielke H, Weikert C, Dusemund B, Putze K, Watzl B, Lampen A, Bischoff SC
J Nutr 2019 Mar 1;149(3):441-450. doi: 10.1093/jn/nxy303. PMID: 30805607
Safety With Echocardiographic Contrast Agents.
Muskula PR, Main ML
Circ Cardiovasc Imaging 2017 Apr;10(4) doi: 10.1161/CIRCIMAGING.116.005459. PMID: 28377467
Active and passive surveillance of enoxaparin generics: a case study relevant to biosimilars.
Grampp G, Bonafede M, Felix T, Li E, Malecki M, Sprafka JM
Expert Opin Drug Saf 2015 Mar;14(3):349-60. Epub 2015 Jan 5 doi: 10.1517/14740338.2015.1001364. PMID: 25557261
Heart disease and stroke statistics--2011 update: a report from the American Heart Association.
Roger VL, Go AS, Lloyd-Jones DM, Adams RJ, Berry JD, Brown TM, Carnethon MR, Dai S, de Simone G, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Greenlund KJ, Hailpern SM, Heit JA, Ho PM, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, McDermott MM, Meigs JB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Rosamond WD, Sorlie PD, Stafford RS, Turan TN, Turner MB, Wong ND, Wylie-Rosett J; American Heart Association Statistics Committee and Stroke Statistics Subcommittee
Circulation 2011 Feb 1;123(4):e18-e209. Epub 2010 Dec 15 doi: 10.1161/CIR.0b013e3182009701. PMID: 21160056Free PMC Article

Therapy

Efficacy and safety of CD19-directed CAR-T cell therapies in patients with relapsed/refractory aggressive B-cell lymphomas: Observations from the JULIET, ZUMA-1, and TRANSCEND trials.
Westin JR, Kersten MJ, Salles G, Abramson JS, Schuster SJ, Locke FL, Andreadis C
Am J Hematol 2021 Oct 1;96(10):1295-1312. Epub 2021 Aug 13 doi: 10.1002/ajh.26301. PMID: 34310745Free PMC Article
SGLT2 Inhibitors: A Review of Their Antidiabetic and Cardioprotective Effects.
Tentolouris A, Vlachakis P, Tzeravini E, Eleftheriadou I, Tentolouris N
Int J Environ Res Public Health 2019 Aug 17;16(16) doi: 10.3390/ijerph16162965. PMID: 31426529Free PMC Article
Energy Drinks Induce Acute Cardiovascular and Metabolic Changes Pointing to Potential Risks for Young Adults: A Randomized Controlled Trial.
Basrai M, Schweinlin A, Menzel J, Mielke H, Weikert C, Dusemund B, Putze K, Watzl B, Lampen A, Bischoff SC
J Nutr 2019 Mar 1;149(3):441-450. doi: 10.1093/jn/nxy303. PMID: 30805607
Safety With Echocardiographic Contrast Agents.
Muskula PR, Main ML
Circ Cardiovasc Imaging 2017 Apr;10(4) doi: 10.1161/CIRCIMAGING.116.005459. PMID: 28377467
Heart disease and stroke statistics--2011 update: a report from the American Heart Association.
Roger VL, Go AS, Lloyd-Jones DM, Adams RJ, Berry JD, Brown TM, Carnethon MR, Dai S, de Simone G, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Greenlund KJ, Hailpern SM, Heit JA, Ho PM, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, McDermott MM, Meigs JB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Rosamond WD, Sorlie PD, Stafford RS, Turan TN, Turner MB, Wong ND, Wylie-Rosett J; American Heart Association Statistics Committee and Stroke Statistics Subcommittee
Circulation 2011 Feb 1;123(4):e18-e209. Epub 2010 Dec 15 doi: 10.1161/CIR.0b013e3182009701. PMID: 21160056Free PMC Article

Prognosis

A 52-week follow-up, multi-center, randomized, double-blinded comparison of efficacy and safety of two hyaluronic acid fillers for the treatment of moderate-to-severe nasolabial folds in Chinese population.
Shao H, Wang L, Tang J, Chen L, Zhang S, Chen Q, Wang C, Yang J, Li W, Zhao H
J Dermatolog Treat 2024 Dec;35(1):2378165. Epub 2024 Jul 14 doi: 10.1080/09546634.2024.2378165. PMID: 39004426
Safety With Echocardiographic Contrast Agents.
Muskula PR, Main ML
Circ Cardiovasc Imaging 2017 Apr;10(4) doi: 10.1161/CIRCIMAGING.116.005459. PMID: 28377467
Active and passive surveillance of enoxaparin generics: a case study relevant to biosimilars.
Grampp G, Bonafede M, Felix T, Li E, Malecki M, Sprafka JM
Expert Opin Drug Saf 2015 Mar;14(3):349-60. Epub 2015 Jan 5 doi: 10.1517/14740338.2015.1001364. PMID: 25557261
The SECURE study: long-term safety of ranibizumab 0.5 mg in neovascular age-related macular degeneration.
Silva R, Axer-Siegel R, Eldem B, Guymer R, Kirchhof B, Papp A, Seres A, Gekkieva M, Nieweg A, Pilz S; SECURE Study Group
Ophthalmology 2013 Jan;120(1):130-9. Epub 2012 Sep 25 doi: 10.1016/j.ophtha.2012.07.026. PMID: 23021093
Heart disease and stroke statistics--2011 update: a report from the American Heart Association.
Roger VL, Go AS, Lloyd-Jones DM, Adams RJ, Berry JD, Brown TM, Carnethon MR, Dai S, de Simone G, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Greenlund KJ, Hailpern SM, Heit JA, Ho PM, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, McDermott MM, Meigs JB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Rosamond WD, Sorlie PD, Stafford RS, Turan TN, Turner MB, Wong ND, Wylie-Rosett J; American Heart Association Statistics Committee and Stroke Statistics Subcommittee
Circulation 2011 Feb 1;123(4):e18-e209. Epub 2010 Dec 15 doi: 10.1161/CIR.0b013e3182009701. PMID: 21160056Free PMC Article

Clinical prediction guides

Comparative Safety and Attributable Healthcare Expenditures Following Inappropriate Versus Appropriate Outpatient Antibiotic Prescriptions Among Adults With Upper Respiratory Infections.
Butler AM, Brown DS, Newland JG, Nickel KB, Sahrmann JM, O'Neil CA, Olsen MA, Zetts RM, Hyun DY, Durkin MJ
Clin Infect Dis 2023 Mar 21;76(6):986-995. doi: 10.1093/cid/ciac879. PMID: 36350187Free PMC Article
Association of Inappropriate Outpatient Pediatric Antibiotic Prescriptions With Adverse Drug Events and Health Care Expenditures.
Butler AM, Brown DS, Durkin MJ, Sahrmann JM, Nickel KB, O'Neil CA, Olsen MA, Hyun DY, Zetts RM, Newland JG
JAMA Netw Open 2022 May 2;5(5):e2214153. doi: 10.1001/jamanetworkopen.2022.14153. PMID: 35616940Free PMC Article
Efficacy and safety of CD19-directed CAR-T cell therapies in patients with relapsed/refractory aggressive B-cell lymphomas: Observations from the JULIET, ZUMA-1, and TRANSCEND trials.
Westin JR, Kersten MJ, Salles G, Abramson JS, Schuster SJ, Locke FL, Andreadis C
Am J Hematol 2021 Oct 1;96(10):1295-1312. Epub 2021 Aug 13 doi: 10.1002/ajh.26301. PMID: 34310745Free PMC Article
Economic Analysis of the Prevention and Control of Nosocomial Infections: Research Protocol.
Tchouaket EN, Sia D, Brousseau S, Kilpatrick K, Boivin S, Dubreuil B, Larouche C, Parisien N, Dubois CA, Brousselle A, Borgès Da Silva R
Front Public Health 2021;9:531624. Epub 2021 Jul 7 doi: 10.3389/fpubh.2021.531624. PMID: 34307266Free PMC Article
Safety With Echocardiographic Contrast Agents.
Muskula PR, Main ML
Circ Cardiovasc Imaging 2017 Apr;10(4) doi: 10.1161/CIRCIMAGING.116.005459. PMID: 28377467

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