Safety of apixaban in VTE
Trkulja V (Source: Drug, Healthcare and Patient Safety)
Source: Drug, Healthcare and Patient Safety - February 17, 2016 Category: Drugs & Pharmacology Source Type: research

Clinical utility, safety, and efficacy of pregabalin in the treatment of fibromyalgia
Santosh Bhusal,1 Sherilyn Diomampo,1 Marina N Magrey2 1Division of Rheumatology, Metrohealth Medical Center, 2Case Western Reserve University School of Medicine at Metrohealth Medical Center, Cleveland OH, USA Abstract: Fibromyalgia is a chronic debilitating medical syndrome with limited therapeutic options. Pregabalin, an anticonvulsant and α-2-Δ subunit receptor ligand, is one of the anchor drugs approved by the US Food and Drug Administration for the treatment of fibromyalgia. The drug has shown clinically meaningful benefits across multiple symptom domains of fibromyalgia. Efficacy of pregabalin in fibromy...
Source: Drug, Healthcare and Patient Safety - February 16, 2016 Category: Drugs & Pharmacology Tags: Drug, Healthcare and Patient Safety Source Type: research

Pregabalin in fibromyalgia
Bhusal S, Diomampo S, Magrey MN (Source: Drug, Healthcare and Patient Safety)
Source: Drug, Healthcare and Patient Safety - February 16, 2016 Category: Drugs & Pharmacology Source Type: research

A fatal adverse effect of cefazolin administration: severe brain edema in a patient with multiple meningiomas
We present a rare case of fatal cefazolin hypersensitivity in a female who was diagnosed with multiple meningiomas and scheduled for craniotomy and tumor removal. Immediately after cefazolin IV administration, the patient developed acute hypertensive crisis, which resolved within 10 minutes after the treatment. This was followed by unexplained metabolic acidosis. The patient then developed severe brain edema 100 minutes later. The patient had facial edema when her face was exposed for the next 30 minutes. A computed tomography scan revealed global brain edema with herniation. She was admitted to the intensive care unit for...
Source: Drug, Healthcare and Patient Safety - February 9, 2016 Category: Drugs & Pharmacology Tags: Drug, Healthcare and Patient Safety Source Type: research

A fatal adverse effect of cefazolin administration
Tribuddharat S, Sathitkarnmanee T, Kitkhuandee A, Theerapongpakdee S, Ngamsaengsirisup K, Chanthawong S (Source: Drug, Healthcare and Patient Safety)
Source: Drug, Healthcare and Patient Safety - February 8, 2016 Category: Drugs & Pharmacology Source Type: research

Benefit & ndash;risk assessment of golimumab in the treatment of refractory ulcerative colitis
(Source: Drug, Healthcare and Patient Safety)
Source: Drug, Healthcare and Patient Safety - February 2, 2016 Category: Drugs & Pharmacology Tags: Drug, Healthcare and Patient Safety Source Type: research

Benefit–risk assessment of golimumab in the treatment of refractory ulcerative colitis
Daniela Pugliese, Carla Felice, Rosario Landi, Alfredo Papa, Luisa Guidi, Alessandro Armuzzi Inflammatory Bowel Disease Unit, Complesso Integrato Columbus, Catholic University, Rome, Italy Abstract: Significant advances in the management of patients with ulcerative colitis (UC) have been made since the introduction of anti-tumor necrosis factor (TNF)-alpha agents, especially for those who fail or do not tolerate conventional therapies. Two drugs, infliximab first, then adalimumab afterward, showed effectiveness in inducing and maintaining long-term remission both in pivotal trials as well as in clinical practice. However,...
Source: Drug, Healthcare and Patient Safety - February 2, 2016 Category: Drugs & Pharmacology Tags: Drug, Healthcare and Patient Safety Source Type: research

Risk assessment of golimumab in the treatment of UC
Pugliese D, Felice C, Landi R, Papa A, Guidi L, Armuzzi A (Source: Drug, Healthcare and Patient Safety)
Source: Drug, Healthcare and Patient Safety - February 2, 2016 Category: Drugs & Pharmacology Source Type: research

Safety and tolerability considerations in the use of sildenafil for children with pulmonary arterial hypertension
Andrew L Dodgen,1 Kevin D Hill1,2 1Department of Pediatrics, Duke University Medical Center, 2Duke Clinical Research Institute, Durham, NC, USA Abstract: Sildenafil is a phosphodiesterase type-5 inhibitor approved for treatment of pulmonary arterial hypertension (PAH) in adults. Data from pediatric trials demonstrate a similar acute safety profile to the adult population but have raised concerns regarding the safety of long-term use in children. Interpretation of these trials remains controversial with major regulatory agencies differing in their recommendations – the US Food and Drug Administration recommends agains...
Source: Drug, Healthcare and Patient Safety - December 15, 2015 Category: Drugs & Pharmacology Tags: Drug, Healthcare and Patient Safety Source Type: research

Safety profile of dalfampridine extended release in multiple sclerosis: 5-year postmarketing experience in the United States
Conclusion: The 5-year US postmarketing safety data of dalfampridine-ER is consistent with the safety profile observed in clinical trials. Incidence of reported seizures remained stable over time. Since commercial availability in March 2010, a warning regarding the risk of anaphylaxis and severe allergic reactions was added to the US prescribing information. Keywords: dalfampridine, fampridine, multiple sclerosis, adverse events, postmarketing safety (Source: Drug, Healthcare and Patient Safety)
Source: Drug, Healthcare and Patient Safety - December 15, 2015 Category: Drugs & Pharmacology Tags: Drug, Healthcare and Patient Safety Source Type: research

Dalfampridine-ER: 5-year postmarketing safety
Jara M, Aquilina T, Aupperle P, Rabinowicz AL (Source: Drug, Healthcare and Patient Safety)
Source: Drug, Healthcare and Patient Safety - December 14, 2015 Category: Drugs & Pharmacology Source Type: research

Sildenafil safety in children
Dodgen AL, Hill KD (Source: Drug, Healthcare and Patient Safety)
Source: Drug, Healthcare and Patient Safety - December 14, 2015 Category: Drugs & Pharmacology Source Type: research

Clinical efficacy, safety, and tolerability of fingolimod for the treatment of relapsing-remitting multiple sclerosis
Alberto Gajofatto,1,2 Marco Turatti,2 Salvatore Monaco,1,2 Maria Donata Benedetti2 1Department of Neurological, Biomedical and Movement Sciences, University of Verona, Verona, Italy; 2Division of Neurology B, Verona University Hospital, Verona, Italy Abstract: Fingolimod is a selective immunosuppressive agent approved worldwide for the treatment of relapsing-remitting multiple sclerosis (MS), a chronic and potentially disabling neurological condition. Randomized double-blind clinical trials have shown that fingolimod significantly reduces relapse rate and ameliorates a number of brain MRI measures, including cere...
Source: Drug, Healthcare and Patient Safety - December 10, 2015 Category: Drugs & Pharmacology Tags: Drug, Healthcare and Patient Safety Source Type: research

Safety and efficacy of fingolimod for multiple sclerosis
Gajofatto A, Turatti M, Monaco S, Benedetti MD (Source: Drug, Healthcare and Patient Safety)
Source: Drug, Healthcare and Patient Safety - December 10, 2015 Category: Drugs & Pharmacology Source Type: research

Challenges facing effective implementation of co-trimoxazole prophylaxis in children born to HIV-infected mothers in the public health facilities
Conclusion: Most children who were initiated with co-trimoxazole prophylaxis did not experience significant opportunistic infections, and the drug was well tolerated. The major barrier for co-trimoxazole prophylaxis was due to frequent out-of-stocks of pediatric co-trimoxazole formulations in the health facilities. Dose determination was based on the age rather than the weight of children, thus creating potential for under- or over-dosing of children.Keywords: health facilities, opportunistic infections, CD4, parents, guardians (Source: Drug, Healthcare and Patient Safety)
Source: Drug, Healthcare and Patient Safety - October 29, 2015 Category: Drugs & Pharmacology Tags: Drug, Healthcare and Patient Safety Source Type: research