Probiotics under the regulatory microscope.

abstract：:Thionamides, selective inhibitors of thyroid peroxidase-mediated iodination by tyrosine residues in thyroglobulin, have been effectively used in the treatment of hyperthyroidism. The choices for initial treatment of patients with Graves' disease differ in various countries, and many physicians around the world prefer ...

journal_title：Expert opinion on drug safety

authors： Azizi F

更新日期：2006-01-01 00:00:00

abstract：INTRODUCTION:The MAPK pathway is a signaling network that plays a key role in many normal cellular processes and in a large number of human malignancies. One of its effectors, MEK, is essential for the carcinogenesis of different tumors. In recent years, several drugs able to inhibit MEK have been assessed in clinical ...

journal_title：Expert opinion on drug safety

authors： Martin-Liberal J,Lagares-Tena L,Larkin J

更新日期：2014-04-01 00:00:00

abstract：OBJECTIVE:To review long-term safety data from the rollover study ETV-901, focusing on adverse events (AEs) with a potential nucleos(t)ide association. METHODS:The open-label study ETV-901 (AI463901) assessed the safety of entecavir in chronic hepatitis B patients who received entecavir, lamivudine or adefovir monothe...

journal_title：Expert opinion on drug safety

authors： Manns MP,Akarca US,Chang TT,Sievert W,Yoon SK,Tsai N,Min A,Pangerl A,Beebe S,Yu M,Wongcharatrawee S

更新日期：2012-05-01 00:00:00

abstract：BACKGROUND:Possible relationship between drug exposure and multiple sclerosis (MS) development is insufficiently investigated, and further challenged by the incomplete understanding of MS etiopathogenesis. The study aims to investigate whether drug exposure could contribute to MS, by analyzing worldwide spontaneous rep...

journal_title：Expert opinion on drug safety

authors： Antonazzo IC,Raschi E,Forcesi E,Riise T,Bjornevik K,Baldin E,De Ponti F,Poluzzi E

更新日期：2018-09-01 00:00:00

abstract：INTRODUCTION:Approximately 40-50% of patients with cutaneous melanoma harbor point mutations in BRAF. BRAF and MEK inhibitors in combination are now a standard therapy for advanced BRAFV600-mutated melanoma. Nevertheless, survival rates with the combination are limited, highlighting the need for further therapeutic imp...

journal_title：Expert opinion on drug safety

authors： Indini A,Mandalà M

更新日期：2020-10-01 00:00:00

abstract：INTRODUCTION:Secukinumab is a human monoclonal antibody that selectively targets and neutralizes interleukin (IL)-17A, a cytokine that is normally involved in mucocutaneous defense against extracellular organisms and is abnormally expressed in psoriasis. In 2015, secukinumab was the first IL-17A inhibitor approved for ...

journal_title：Expert opinion on drug safety

authors： Blauvelt A

更新日期：2016-10-01 00:00:00

abstract：INTRODUCTION:A growing number of children globally are being treated for multidrug-resistant tuberculosis (MDR-TB). The second-line injectable antituberculosis medications amikacin, kanamycin and capreomycin, traditionally a mainstay of MDR-TB treatment, cause important adverse effects including permanent sensorineural...

journal_title：Expert opinion on drug safety

authors： Garcia-Prats AJ,Schaaf HS,Hesseling AC

更新日期：2016-11-01 00:00:00

abstract：INTRODUCTION:Oral antidiabetic medications are important in many type 2 diabetes care plans. AREAS COVERED:The article summarizes the cardiovascular and renal safety data for DPP-4 inhibitors and SGLT-2 inhibitors and specific safety data particular to each class. EXPERT OPINION:DPP-4 and SGLT-2 inhibitors provide un...

journal_title：Expert opinion on drug safety

authors： Lamos EM,Hedrington M,Davis SN

更新日期：2019-08-01 00:00:00

abstract：INTRODUCTION:Pain management has become a widely discussed topic throughout all medical subspecialties. Although pediatric pain management has evolved significantly in its recent history, there is continued interest in the adequacy of pain treatment, both in the acute inpatient setting as well as the postoperative and ...

journal_title：Expert opinion on drug safety

authors： Martin DP,Bhalla T,Beltran R,Veneziano G,Tobias JD

更新日期：2014-01-01 00:00:00

abstract：INTRODUCTION:The antimalarial drug hydroxychloroquine (HCQ) is widely used to treat various rheumatic diseases. Many autoimmune diseases occur in women of child-bearing age who may become pregnant while on therapy, which raises concerns regarding the teratogenicity of HCQ and its effect on the outcome of the pregnancy....

journal_title：Expert opinion on drug safety

authors： Abarientos C,Sperber K,Shapiro DL,Aronow WS,Chao CP,Ash JY

更新日期：2011-09-01 00:00:00

abstract：INTRODUCTION:Unintended harm from prescribing errors remains a prevalent concern in healthcare leading to significant morbidity and mortality around the world. Prescribers face new challenges to their practice in modern times such as increasingly complex health-care systems, an aging population with increasing multimor...

journal_title：Expert opinion on drug safety

authors： Coleman JJ

更新日期：2019-02-01 00:00:00

abstract：:Colchicine has been used for over 2000 years. Intravenous (i.v.) colchicine has been used for the treatment of acute gout since the 1950s. I.v. and oral colchicine were 'grandfathered' before the 1969 FDA Phase III trials for drug toxicity became law. Data on toxic reactions are, therefore, based only on passive surve...

journal_title：Expert opinion on drug safety

authors： Schlesinger N

更新日期：2007-11-01 00:00:00

abstract：INTRODUCTION:There is a continuing need for an immunosuppressive therapy that offers a high benefit-risk profile for renal transplant recipients, supporting long-term patient and graft survival while minimizing cumulative nephrotoxicity and other side effects. Belatacept , the first biological agent developed for prima...

journal_title：Expert opinion on drug safety

authors： Grinyó JM,Budde K,Citterio F,Charpentier B

更新日期：2013-01-01 00:00:00

abstract：INTRODUCTION:Pembrolizumab is a highly selective fully human immunoglobulin 4 monoclonal antibody against programmed death 1 (PD-1). Phase II and III trials have demonstrated that pembrolizumab has antitumor activity in previously treated patients with advanced gastric cancer (AGC). AREA COVERED:Pembrolizumab was appr...

journal_title：Expert opinion on drug safety

authors： Mishima S,Kawazoe A,Shitara K

更新日期：2020-09-01 00:00:00

abstract：INTRODUCTION:Hepatitis C virus is a hepatotropic virus that generally leads to chronic hepatitis and various harmful sequelae. The lone standard of treatment has been pegylated interferon and ribavirin, which produces a modest response and many side effects. However, a new era of management was declared with the introd...

journal_title：Expert opinion on drug safety

authors： El Kassas M,Elbaz T,Hafez E,Esmat G

更新日期：2016-12-01 00:00:00

abstract：:Background: The safety and effectiveness of vonoprazan-based Helicobacter pylori (H. pylori) eradication therapy in routine clinical practice, and patient characteristics that influence safety and effectiveness, have not been well investigated.Methods: H. pylori-positive patients with gastric ulcer, duodenal ulcer, id...

journal_title：Expert opinion on drug safety

authors： Ashida K,Honda Y,Sanada K,Takemura Y,Sakamoto S

更新日期：2019-12-01 00:00:00

abstract：INTRODUCTION:Obesity is associated with an increased risk of cardiovascular morbidity and mortality. Four medications are approved by the US Food and Drug Administration (FDA) for chronic weight management when used as an adjunct to a reduced-calorie diet and increased physical activity in adults. These medications res...

journal_title：Expert opinion on drug safety

authors： Chao AM,Wadden TA,Berkowitz RI,Quigley K,Silvestry F

更新日期：2020-09-01 00:00:00

abstract：INTRODUCTION:Carbonic anhydrase (CA) inhibitors have an impressive safety record despite the multiple functions that CA isozymes serve because they are not fully inhibited with most dosing. While reducing the targeted CA-dependent process sufficiently for disease control, residual activity and uncatalyzed rates in comb...

journal_title：Expert opinion on drug safety

authors： Swenson ER

更新日期：2014-04-01 00:00:00

abstract：BACKGROUND:This meta-analysis has been conducted to determine the risk of elevated transaminases associated with immune checkpoint inhibitors use in patients with cancer. METHODS:Studies eligible for our analysis included randomized Phase II and III trials of patients with cancer on ipilimumab, nivolumab, pembrolizuma...

journal_title：Expert opinion on drug safety

authors： Abdel-Rahman O,ElHalawani H,Fouad M

更新日期：2015-10-01 00:00:00

abstract：INTRODUCTION:Adult onset Still disease (AOSD) is a rare systemic inflammatory condition. The clinical spectrum of this disease ranges from self-limiting forms with mild symptoms to life-threatening cases. Glucocorticoids and non-steroidal anti-inflammatory drugs (NSAIDs) represent the first line of therapy for AOSD, wi...

journal_title：Expert opinion on drug safety

authors： Cavalli G,Farina N,Campochiaro C,Baldissera E,Dagna L

更新日期：2020-12-01 00:00:00

abstract：INTRODUCTION:Basiliximab is a chimeric monoclonal antibody directed against the alpha chain of interleukin-2 receptor (IL-2R). When administered intravenously at a dosage of 20 mg at the time of transplantation and 4 days later, basiliximab saturates the alpha chain of IL-2R for 4 weeks. AREAS COVERED:This review eval...

journal_title：Expert opinion on drug safety

authors： Ponticelli C

更新日期：2014-03-01 00:00:00

abstract：:Introduction: Clozapine remains the most effective antipsychotic for treatment-refractory schizophrenia. However, ~40% of the patients respond insufficiently to clozapine. Clozapine's effects, both beneficial and adverse, have been proposed to be partially attributable to its main metabolite, N-desmethylclozapine (NDM...

journal_title：Expert opinion on drug safety

authors： Costa-Dookhan KA,Agarwal SM,Chintoh A,Tran VN,Stogios N,Ebdrup BH,Sockalingam S,Rajji TK,Remington GJ,Siskind D,Hahn MK

更新日期：2020-01-01 00:00:00

abstract：BACKGROUND:Gallstone disease is common in Western countries. Statins reduce biliary cholesterol secretion and have anti-inflammatory effects, suggesting that they may play a role in reducing the incidence of surgically treated gallstone disease. AIM:To examine a potential association between statin administration and ...

journal_title：Expert opinion on drug safety

authors： Merzon E,Weiss NS,Lustman AJ,Elhayani A,Dresner J,Vinker S

更新日期：2010-07-01 00:00:00

abstract：INTRODUCTION:The goal of antiviral therapy in patients with chronic hepatitis C is to slow or halt the progression of fibrosis and prevent the development of cirrhosis. Accordingly, antiviral treatment is proposed for a large population of patients with chronic hepatitis. AREAS COVERED:The standard-of-care for chronic...

journal_title：Expert opinion on drug safety

authors： Calvaruso V,Mazza M,Almasio PL

更新日期：2011-05-01 00:00:00

abstract：:COX-2 selective inhibitors provide analgesia and blunt inflammation while also sparing the gastrointestinal tract from classic NSAID toxicity. Therapeutic effects are thought to result from inhibition of the inflammatory COX-2 isoform. Organ sparing is considered the result of preservation of homeostatic COX-1 enzyme ...

journal_title：Expert opinion on drug safety

authors： Perazella MA

更新日期：2002-05-01 00:00:00

abstract：INTRODUCTION:The Annual Meeting of the Safety Pharmacology (SP) Society is a yearly event designed to keep attendees abreast of how to best identify and mitigate organ function liabilities of candidate drugs selected for clinical assessment. AREAS COVERED:Heart rate (HR) and blood pressure (BP) effects of candidate dr...

journal_title：Expert opinion on drug safety

authors： Cavero I

更新日期：2015-06-01 00:00:00

abstract：:Objectives: Sensory adverse drug reactions (ADRs) are generally expected to be transient in nature. However, spontaneous reports describe frequently these events as long-lasting or unresolved. In this study, the authors reviewed the Eudravigilance publicly accessible database to describe the volume and expectedness of...

journal_title：Expert opinion on drug safety

authors： Ferraro S,Convertino I,Leonardi L,Blandizzi C,Tuccori M

更新日期：2019-12-01 00:00:00

abstract：:Objectives: Bullous pemphigoid, an autoimmune dermatological disease, may be associated with the use of a relatively new anti-cancer drug class, PD-1 inhibitors, which includes pembrolizumab and nivolumab. This paper analyzes the signals between PD-1 inhibitors and bullous pemphigoid based upon the reported real-world...

journal_title：Expert opinion on drug safety

authors： Aggarwal P

更新日期：2019-07-01 00:00:00

abstract：:Recombinant activated Factor VII (rFVIIa) has been successfully used in the treatment of haemophilia A and B with associated inhibitors for some years. Activated Factor VII binds to activated platelets independently of tissue factor. The resulting stimulation of an exaggerated early thrombin burst at sites of vascular...

journal_title：Expert opinion on drug safety

authors： Wilson SJ,Bellamy MC,Giannoudis PV

更新日期：2005-05-01 00:00:00

abstract：INTRODUCTION:Epidural steroid injections (ESI) are a commonly utilized treatment for cervical and lumbar radicular pain. All medical procedures and medications carry an inherent level of risk, that must be balanced with the effectiveness of the treatment to determine the risk to benefit ratio for a patient. AREAS COVE...

journal_title：Expert opinion on drug safety

authors： Schneider B,Zheng P,Mattie R,Kennedy DJ

更新日期：2016-08-01 00:00:00