Abstract：
PURPOSE:The information that is available when marketing authorizations are approved is limited. Pharmacovigilance has an important role during the postauthorization period, and alerts published by national authorities allow health care professionals to be informed about new data on safety profiles. This study therefore sought to analyze all safety alerts published by the Portuguese National Authority of Medicines and Health Products I.P. (INFARMED). METHODS:We conducted an observational study of all alerts published on the INFARMED website from January 2002 through December 2014. From the data included in the alerts, the following information was abstracted: active substance name (and trade name), event that led to the alert, and the resulting safety measures. Active substances were classified according to the Anatomical Therapeutic Chemical (ATC) code. FINDINGS:A total of 562 alerts were published, and 304 were eligible for inclusion. The musculoskeletal system was the ATC code with more alerts (n = 53), followed by the nervous system (n = 42). Communication of the information and recommendations to the health care professionals and the public in general was the most frequent safety measure (n = 128), followed by changes in the Summary of the Product Characteristics and package information leaflet (n = 66). During the study period, 26 marketing authorizations were temporarily suspended and 10 were revoked. IMPLICATIONS:The knowledge of the alerts published during the postmarketing period is very useful to the health care professionals for improving prescription and use of medicines and to the scientific community for the development of new researches.
journal_name
Clin Therjournal_title
Clinical therapeuticsauthors
Soares S,Roque F,Teixeira Rodrigues A,Figueiras A,Herdeiro MTdoi
10.1016/j.clinthera.2015.07.015subject
Has Abstractpub_date
2015-09-01 00:00:00pages
2122-8issue
9eissn
0149-2918issn
1879-114Xpii
S0149-2918(15)00955-8journal_volume
37pub_type
杂志文章abstract：:Hypoglycemia in people with insulin-treated type 2 diabetes can be a limiting factor for management and a barrier to optimizing glycemic control. Even mild episodes of hypoglycemia can affect an individual's quality of life, and fear of hypoglycemia can lead to underinsulinization. This article explores the prevalence...
journal_title：Clinical therapeutics
pub_type： 杂志文章,评审
doi：10.1016/j.clinthera.2016.09.020
更新日期：2017-08-01 00:00:00
abstract：BACKGROUND:Recently approved for the treatment of schizophrenia, aripiprazole represents the sixth second-generation antipsychotic (SGA) introduced to the US market. Aripiprazole is considered a partial dopaminergic agonist, acting on both postsynaptic dopamine(2) receptors and presynaptic autoreceptors, in addition to...
journal_title：Clinical therapeutics
pub_type： 杂志文章,评审
doi：10.1016/s0149-2918(04)90066-5
更新日期：2004-05-01 00:00:00
abstract：:Faced with rising drug costs and an increase in type-1 beta-lactamase resistance, hospitals have been looking for ways to contain antibiotic costs while continuing to provide quality medical care. The hospital pharmacy at Montefiore Medical Center, Moses Division, has developed a number of programs aimed at identifyin...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：
更新日期：1993-01-01 00:00:00
abstract：:Quinfamide, a luminal amebicide, is a dichloroacetyl quinolol used to treat chronic and subacute intestinal amebiasis. Several previous dose-ranging studies have indicated that quinfamide is effective in a total dose of 300, 600, or 1,200 mg. The present study was undertaken to determine the efficacy of 100- and 200-m...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：
更新日期：1983-01-01 00:00:00
abstract：:Nicardipine hydrochloride is the first intravenous dihydropyridine calcium antagonist to become available in the United States. Its chemical structure makes it unique among its drug class and confers clinically useful properties for the treatment of acute cardiovascular conditions, such as ischemia, hypertension, cong...
journal_title：Clinical therapeutics
pub_type： 杂志文章,评审
doi：
更新日期：1988-01-01 00:00:00
abstract：:After a brief analysis of the financial and health care motives that have led to the current boom in disease management (DM) programs, this paper discusses the pragmatic realities of a particular DM program for treating asthma. A model of the institutional structures necessary for DM to work is presented, emphasizing ...
journal_title：Clinical therapeutics
pub_type：
doi：10.1016/s0149-2918(96)80089-0
更新日期：1996-11-01 00:00:00
abstract：:Since the introduction of angiotensin converting enzyme (ACE) inhibitors into clinical use, much information has been accumulated in animal models and man regarding their effects on renal function in different disease states. Enalapril, the first nonsulfhydryl ACE inhibitor approved for general use in the United State...
journal_title：Clinical therapeutics
pub_type： 杂志文章,评审
doi：
更新日期：1989-09-01 00:00:00
abstract：BACKGROUND:Breast cancer surgery performed with the patient under general anesthesia has been associated with a relatively high incidence of postoperative nausea and vomiting (PONV). Between 60% and 80% of patients who undergo mastectomy (with axillary dissection) experience PONV. We previously reported that propofol a...
journal_title：Clinical therapeutics
pub_type： 杂志文章,随机对照试验,收录出版
doi：10.1016/j.clinthera.2008.11.011
更新日期：2008-11-01 00:00:00
abstract：BACKGROUND:The role of folate in pregnancy is well established, with most prenatal vitamins (PNVs) on the market containing at least 800 μg of folic acid. Folic acid must be converted in the body to L-methylfolate, the natural and biologically active form of folate. The role of vitamin B(12) in pregnancy is less charac...
journal_title：Clinical therapeutics
pub_type： 杂志文章,多中心研究
doi：10.1016/j.clinthera.2011.02.010
更新日期：2011-02-01 00:00:00
abstract：BACKGROUND:Postherpetic neuralgia (PHN), which affects up to 70% of elderly persons with herpes zoster, can have debilitating effects, including physical and social disability and significant psychological distress. A variety of agents have been used, either singly or in combination, to control PHN, including topical a...
journal_title：Clinical therapeutics
pub_type： 杂志文章,评审
doi：10.1016/s0149-2918(03)80320-x
更新日期：2003-10-01 00:00:00
abstract：PURPOSE:The International Conference on Harmonisation E14 guideline mandates an intensive cardiac safety evaluation in a clinical thorough QT study, typically in healthy subjects, for all new non-antiarrhythmic drugs with systemic bioavailability. This thorough QT study investigated the effects of therapeutic (2 mg) an...
journal_title：Clinical therapeutics
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.clinthera.2015.09.006
更新日期：2015-11-01 00:00:00
abstract：:Flecainide, a new antiarrhythmic agent, was given to eight healthy men to ascertain plasma drug levels and to assess tolerance for the drug. Each subject received a single intravenous (IV) dose (0.5, 1, 1.5, or 2 mg/kg) of flecainide, and plasma levels of unchanged flecainide were measured by gas-liquid chromatography...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：
更新日期：1984-01-01 00:00:00
abstract：PURPOSE:UR-1505 is a new small molecule with immune modulator properties intended for the topical treatment of inflammatory skin diseases that has shown anti-inflammatory effects in models of skin inflammation. We compared the activity of UR-1505 ointment against its vehicle in the treatment of atopic dermatitis. Secon...
journal_title：Clinical therapeutics
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.clinthera.2015.06.005
更新日期：2015-09-01 00:00:00
abstract：:Pediatric patients experience unique differences from the adult population in pharmacokinetic parameters and, consequently, require individualized dosing. Medications useful in pediatric medicine often lack a therapeutic indication and dosing guideline for this population. In addition, the absence of an available pedi...
journal_title：Clinical therapeutics
pub_type： 杂志文章,评审
doi：
更新日期：1991-09-01 00:00:00
abstract：BACKGROUND:Hereditary angioedema (HAE) is a rare, potentially life-threatening autosomal dominant disease characterized by recurrent angioedema attacks that affect the skin, gastrointestinal tract, and airway, including the larynx. Pharmacologic developments in HAE treatment have culminated in the recent introduction o...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2012.02.003
更新日期：2012-03-01 00:00:00
abstract：BACKGROUND:According to prescribing information for rheumatoid arthritis (RA) treatments in the United States, infliximab should be administered at weeks 1, 2, 6, and then every 8 weeks starting at a 3-mg/kg dose, with flexible dosing up to 10 mg/kg and/or every 4 weeks based on clinical response. OBJECTIVE:This study...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2012.10.010
更新日期：2012-12-01 00:00:00
abstract：PURPOSE:Surgery, radiotherapy, and chemotherapy are the mainstays of cervical cancer treatment. Many patients receive multiple treatment modalities, each with its own long-term effects. Given the high 5-year survival rate for cervical cancer patients, evaluation and improvement of long-term quality of life are essentia...
journal_title：Clinical therapeutics
pub_type： 杂志文章,评审
doi：10.1016/j.clinthera.2014.11.013
更新日期：2015-01-01 00:00:00
abstract：PURPOSE:Intensive blood pressure (BP) lowering is important for the treatment of hypertension; however, it has been a challenge to achieve target BP in many patients. The purpose of this study was to explore the optimal dosage of a fixed-dose combination of candesartan cilexetil (CAN) and amlodipine besylate (AML), by ...
journal_title：Clinical therapeutics
pub_type： 杂志文章,多中心研究,随机对照试验
doi：10.1016/j.clinthera.2017.06.014
更新日期：2017-08-01 00:00:00
abstract：PURPOSE:Although the efficacy of canagliflozin has been well established in clinical trials, research regarding its use and impact on outcomes in clinical practice has been limited by the availability of data on observations up to and beyond 6 months after the initial use of canagliflozin. The purpose of this study was...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2016.07.009
更新日期：2016-09-01 00:00:00
abstract：:Forty patients with symptoms of rheumatoid arthritis were treated with daily injections of 100 micrograms of human leukocyte interferon or saline placebo. Twenty patients received the interferon for nine weeks and were then switched to placebo for nine weeks, and 20 patients were started on placebo and were then switc...
journal_title：Clinical therapeutics
pub_type： 临床试验,杂志文章
doi：
更新日期：1986-01-01 00:00:00
abstract：PURPOSE:The limitations of current US Food and Drug Administration (FDA)-approved medications for the treatment of attention-deficit/hyperactivity disorder (ADHD) set the need for the development of novel, effective, and tolerable medications to treat this disorder. The purpose of this study was to evaluate whether tre...
journal_title：Clinical therapeutics
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.clinthera.2020.05.021
更新日期：2020-08-01 00:00:00
abstract：BACKGROUND:One approach to treating allergic rhinoconjunctivitis is the concomitant use of an intranasal spray such as fluticasone propionate to alleviate nasal symptoms and a topical or systemic agent to relieve ocular symptoms. It has not yet been determined whether a topical or systemic agent is more effective for t...
journal_title：Clinical therapeutics
pub_type： 临床试验,杂志文章,随机对照试验
doi：10.1016/s0149-2918(02)80027-3
更新日期：2002-07-01 00:00:00
abstract：BACKGROUND:Patients with glaucoma or ocular hypertension may have inadequately controlled intraocular pressure (IOP) or experience adverse effects with their current medication regimens. OBJECTIVE:This post hoc reanalysis determined the effectiveness and tolerability of brimonidine used as replacement therapy in a rea...
journal_title：Clinical therapeutics
pub_type： 临床试验,杂志文章,多中心研究
doi：10.1016/s0149-2918(00)87977-1
更新日期：2000-01-01 00:00:00
abstract：PURPOSE:This study was designed to evaluate the safety and pharmacokinetic profiles of MRX-I tablet, an oxazolidinone antibacterial agent, in healthy Chinese subjects. METHODS:The study was composed of 3 sequential periods. Period 1 was a randomized, double-blind, placebo-controlled, sequential ascending dose (50 to 1...
journal_title：Clinical therapeutics
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.clinthera.2017.12.017
更新日期：2018-02-01 00:00:00
abstract：PURPOSE:Prostate cancer is the second most common cancer among men worldwide. In the past 10 years in Iran, prostate cancer has increased and become more common among hormone-related cancers. As the percentage of seniors in the population increases, the economic burden of this cancer will likely increase significantly....
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：10.1016/j.clinthera.2018.11.001
更新日期：2019-01-01 00:00:00
abstract：BACKGROUND:The Clinical Brain Disorders Branch Sibling Study data set was initiated in 1996 to examine genetic associations and to identify biological traits associated with susceptibility gene effects. Characterizing genes--and translating their effects on brain development and function--has potential implications for...
journal_title：Clinical therapeutics
pub_type： 杂志文章,评审
doi：10.1016/j.clinthera.2005.07.016
更新日期：2005-01-01 00:00:00
abstract：:A four-week crossover study to compare the efficacy of an acne cleanser containing 2% salicylic acid with that of a 10% benzoyl peroxide wash was conducted in 30 patients with acne vulgaris. The results demonstrated that only patients treated with the salicylic acid cleanser had a significant reduction in comedones. P...
journal_title：Clinical therapeutics
pub_type： 杂志文章
doi：
更新日期：1989-03-01 00:00:00
abstract：BACKGROUND:Enzyme replacement therapy (ERT) with imiglucerase is a well-established, effective treatment for Gaucher disease. However, there have been no published reports regarding the excretion of imiglucerase into human breast milk and its effects on the nursing infant. OBJECTIVE:This letter reports on the successf...
journal_title：Clinical therapeutics
pub_type： 信件
doi：10.1016/j.clinthera.2010.11.008
更新日期：2010-11-01 00:00:00
abstract：:A double-blind, randomized, placebo-controlled trial was undertaken to evaluate the effect of penicillin on the pneumococcal carrier state of 32 men with chronic bronchitis. Treatment consisted of 250-mg phenoxymethyl penicillin or placebo tablets taken by mouth twice daily for periods of one to three years. Penicilli...
journal_title：Clinical therapeutics
pub_type： 临床试验,杂志文章,随机对照试验
doi：
更新日期：1986-01-01 00:00:00
abstract：BACKGROUND:Rufinamide is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in patients aged ≥4 years. OBJECTIVES:The primary purpose of this study was to compare the relative bioavailability and other pharmacokinetics of rufinamide administered as a 400-mg tablet formulation (r...
journal_title：Clinical therapeutics
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.clinthera.2011.01.016
更新日期：2011-01-01 00:00:00
