Abstract:
WHAT IS KNOWN AND OBJECTIVE:New first-in-class (FIC) drugs with novel mechanisms of action may be highly effective, but lack adequate safety information, and therefore may be associated with crucial post-marketing safety issues. The objective of this study was to evaluate the post-marketing risk of FIC drug with comparison occurrence of Post-marketing safety-related regulatory actions (PSRAs) due to FIC drugs to that due to other new drugs. METHODS:A full list of all new molecular entities and therapeutic biologics, except diagnostic agents and vaccines, which were approved in the United States between 1 January 2003, and 31 December 2013, were included in this study. Drugs with novel mechanisms of action at the time of approval were classified as the FIC cohort and other new drugs as the control cohort. PSRAs were defined as safety-related post-marketing withdrawal, new issuance or the addition of black box warnings. Specifically, we identified PSRAs associated with adverse drug reactions (ADR-PSRAs). Subsequently, we identified drug allergy ADR-PSRAs and class-effect ADR-PSRAs, and also extracted drug-specific ADR-PSRAs. To evaluate the post-marketing safety risk of FIC drugs, we estimated the odds ratio of the occurrence of ADR-PSRAs between the FIC cohort and the control cohort. RESULTS AND DISCUSSION:The odds ratio of the occurrence of all ADR-PSRA in the FIC cohort was 0.96 (95% CI: 0.57-1.61, P = .8758), showing no difference compared to that of the control cohort. However, the odds ratio of the occurrence of drug-specific ADR-PSRAs in the FIC cohort was 2.06 (95% CI: 1.20-3.55, P = .0091). WHAT IS NEW AND CONCLUSION:This study demonstrated that a strong relationship existed between FIC drugs and the occurrence of drug-specific ADR-PSRAs, suggesting that post-marketing safety risk for FIC drugs is higher than that for other new drugs given the same class at approval.
journal_name
J Clin Pharm Therjournal_title
Journal of clinical pharmacy and therapeuticsauthors
Ikeda J,Kaneko M,Narukawa Mdoi
10.1111/jcpt.13096subject
Has Abstractpub_date
2020-06-01 00:00:00pages
496-502issue
3eissn
0269-4727issn
1365-2710journal_volume
45pub_type
杂志文章abstract:WHAT IS KNOWN AND OBJECTIVE:Fluconazole is an antifungal agent that is commonly used to treat patients with serious systemic fungal infections in intensive care units. Fosfluconazole is a phosphate prodrug of fluconazole, which was developed to reduce the volume of fluid required to administer fluconazole by intravenou...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章
doi:10.1111/j.1365-2710.2011.01297.x
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abstract:BACKGROUND AND OBJECTIVE:Moxifloxacin is a new fluorquinolone with broad-spectrum activity. It is suitable for treating peritonitis in peritoneal dialysis (PD) patients. The objective of this study was to test stability of moxifloxacin in PD solutions stored at different temperatures. METHODS:Dialysis solution bags we...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章
doi:10.1111/j.1365-2710.2006.00758.x
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journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1046/j.1365-2710.1999.00238.x
更新日期:1999-10-01 00:00:00
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journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 临床试验,杂志文章
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更新日期:2004-10-01 00:00:00
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journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章,随机对照试验
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更新日期:2018-06-01 00:00:00
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journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章
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journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章,评审
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更新日期:2008-08-01 00:00:00
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journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章
doi:10.1111/jcpt.12251
更新日期:2015-06-01 00:00:00
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journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章
doi:10.1111/j.1365-2710.1989.tb00240.x
更新日期:1989-06-01 00:00:00
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journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章
doi:10.1111/j.1365-2710.2011.01294.x
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journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章
doi:10.1111/j.1365-2710.1997.tb00005.x
更新日期:1997-04-01 00:00:00
abstract:WHAT IS KNOWN AND OBJECTIVE:Amlodipine overdose is common; however, the dose and timing of intravenous lipid emulsion (ILE) therapy as a management strategy remain debatable. CASE DESCRIPTION:A 73-year-old man received a single bolus (1.5 mL/kg) of ILE therapy following massive ingestion of multiple drugs, including a...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type:
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更新日期:2019-12-01 00:00:00
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journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章
doi:10.1046/j.1365-2710.1997.10475104.x
更新日期:1997-08-01 00:00:00
abstract:WHAT IS KNOWN AND OBJECTIVE:Obsessive-compulsive disorder (OCD) is a chronic neuropsychiatric disorder. Selective serotonin reuptake inhibitors (SSRIs) are the first line of medication for OCD treatment; however, 40%-60% of patients with OCD do not respond to SSRIs adequately. There are growing pieces of evidence which...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章
doi:10.1111/jcpt.12766
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journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章
doi:10.1111/jcpt.12489
更新日期:2017-04-01 00:00:00
abstract::The extent and factors that influence drug use were studied in two rural cohorts of Finnish men. The men aged between 65 and 84 years belonged to the Finnish study population of the 25-year follow-up of the 'Seven Countries Study'. Of the original 1,711 men in 1959, 766 were still alive in 1984. The participation rate...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章
doi:10.1111/j.1365-2710.1990.tb00365.x
更新日期:1990-04-01 00:00:00
abstract:OBJECTIVES:Assessment of mean 24 h oestradiol (E2) and oestrone (E1) concentration and basic FSH secretion in postmenopausal asthmatic women, before and after HRT use, and to identify any connections between changes in hormone concentrations and patients' clinical state. SUBJECTS:Postmenopausal women (55 asthmatic and...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章
doi:10.1046/j.1365-2710.2000.00310.x
更新日期:2000-12-01 00:00:00
abstract:BACKGROUND:Personal imports of unapproved drugs are made by physicians and patients in Japan. Such imports require submission of a request for an import certificate from the Regional Bureau of Health and Welfare (RBHW). So far, there have been few reports on personal imports of drugs in Japan. OBJECTIVE:To assess the ...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章
doi:10.1111/j.1365-2710.2008.00941.x
更新日期:2008-10-01 00:00:00
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journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1111/j.1365-2710.1993.tb00607.x
更新日期:1993-06-01 00:00:00
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journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章
doi:10.1111/j.1365-2710.2012.01337.x
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journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章,评审
doi:10.1111/jcpt.13326
更新日期:2020-12-05 00:00:00
abstract::Parenterals, sterile preparations intended to be injected in man or animal, should be free from pyrogenic substances which are able to raise the thermostatic setting in the hypothalamus. This article gives an up-to-date review of the principal detection and quantification methods for these agents, with special attenti...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章,评审
doi:10.1111/j.1365-2710.1987.tb00531.x
更新日期:1987-08-01 00:00:00
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journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章,meta分析,评审
doi:10.1111/jcpt.12147
更新日期:2014-06-01 00:00:00
abstract:WHAT IS KNOWN AND OBJECTIVE:The HbA1C marker used in assessing diabetes control quality is not sufficient in diabetes patients with thalassaemia. CASE DESCRIPTION:A male diabetic patient with thalassaemia was hospitalized due to distal neuropathic pain, right toe trophic ulcer, unacceptable five-point glycaemic profil...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章,评审
doi:10.1111/jcpt.13073
更新日期:2020-04-01 00:00:00
abstract:WHAT IS KNOWN AND OBJECTIVE:There are various reasons why antiepileptic treatment can fail. One is drug-resistant epilepsies, but non-adherence, or poor adherence, to treatment may make some patients' treatment ineffective. The consequences of poor adherence include treatment failure or introduction of more complex tre...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章
doi:10.1111/jcpt.12615
更新日期:2018-02-01 00:00:00
abstract:WHAT IS KNOWN AND OBJECTIVE:Appraisal of drug information centres (DICs) is mainly by word of mouth communication and surveys of overall user satisfaction. Efforts to study the impact of this type of informatics and decision support systematically are generally lacking within the healthcare system. COMMENT:Scandinavia...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章
doi:10.1111/jcpt.12804
更新日期:2019-06-01 00:00:00
abstract::Drug infusions can be exposed for prolonged periods to 'in-use' conditions where the temperature of an infusion in a holster-worn infusion pump may reach 37 degrees C. In this study, the stability of three cytotoxic drug infusions (carboplatin, 5-fluorouracil and mitozantrone) and one analgesic infusion (diamorphine H...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章
doi:10.1111/j.1365-2710.1991.tb00293.x
更新日期:1991-04-01 00:00:00
abstract:PURPOSE:Empirical use of intravenous (IV) itraconazole (ITZ) for febrile neutropenic patients has recently been introduced in Korea. This study was designed to investigate the population pharmacokinetics (PK) of IV-ITZ. METHODS:Sparse PK data were collected from febrile neutropenic patients undergoing empirical ITZ th...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章
doi:10.1111/j.1365-2710.2008.00999.x
更新日期:2009-06-01 00:00:00
abstract:WHAT IS KNOWN AND OBJECTIVE:Gabapentin, a γ-aminobutyric acid derivative, is used for the treatment of partial onset seizures, postherpetic neuralgia, diabetic neuropathy and a host of other neurological disorders. CASE DESCRIPTION:A 44-year-old woman with spinal stenosis was prescribed gabapentin for pain. Two months...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type:
doi:10.1111/jcpt.12840
更新日期:2019-08-01 00:00:00
abstract::A high-performance liquid chromatographic method for the analysis of ranitidine in plasma and urine is described. Plasma samples were extracted with dichloromethane while urine samples were injected directly after dilution. The mobile phase consisted of: 0.05 M ammonium acetate buffer containing 0.01 M octane sulphona...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章
doi:10.1111/j.1365-2710.1988.tb00204.x
更新日期:1988-10-01 00:00:00