adverse reactions

OBJECTIVE: This extension study provided continued treatment to subjects with active rheumatoid arthritis who had participated for ≥16 weeks in a pharmacokinetic similarity study of PF-05280586 (potential rituximab biosimilar). Objectives were to evaluate overall pharmacokinetics, pharmacodynamics, immunogenicity, safety, and tolerability of PF-05280586 after transition from a licensed rituximab product to PF-05280586, and followup of biomarker and efficacy assessments. METHODS: Subjects were offered ≤3 additional courses of treatment of PF-05280586, with or without a single transition from rituximab EU (rituximab-EU) or US (rituximab-US) to PF-05280586...

Ganoderma lucidum is an edible medicinal mushroom known as "Lingzhi" in China and "Reishi or Manetake" in Japan. It is a highly prized vitality-enhancing herb for more than 2000 years. G. lucidum polysaccharide (GLPS) has been identified as one of the major bioactive components and developed into a drug named "Ji 731 Injection" in China since 1973. The large-scale production of the drug began in 1985 and approved by the Chinese FDA as "Polysaccharidum of G. lucidum Karst Injection" (Ling Bao Duo Tang Zhu She Ye) in 2000, which is applied intramuscularly...

RATIONALE, AIMS, AND OBJECTIVES: Discharge medication counselling has produced improved quality of care and health outcomes, especially by reducing medication errors and readmission rates, and improving medication adherence. However, no studies have assembled an evidence-based discharge counselling process for clinical pharmacists. Thus, the present study aims to map the components of the pharmacist-led discharge medication counselling process. METHODS: We performed a scoping review by searching electronic databases (Pubmed, Scopus, and DOAJ) and conducting a manual search to identify studies published up to July 2017...

BACKGROUND: Cutaneous adverse food reaction (CAFR) is diagnosed by performing an elimination diet trial utilizing prescription or home-cooked diets followed by provocative challenge. OBJECTIVES: To report findings of PCR analysis of a prescription vegetarian diet (RCV) for undeclared proteins of animal origin, as well as to describe its utilization for diagnosis and management of dogs suspected of having CAFR. ANIMALS: Three client-owned dogs...

Risk assessment of metallic nanoparticles (NP) is critically affected by the concern that toxicity goes beyond that of the metallic ion. This study addressed this concern for soils with silver (Ag)-NP using the Ag-sensitive nitrification assay. Three agricultural soils (A,B,C) were spiked with equivalent Ag doses of either Ag-NP (d = 13 nm) or AgNO3 . Soil solution was isolated and monitored over 97 days with due attention to accurate Ag fractionation at low (∼10 µg L-1 ) Ag concentrations. Truly dissolved (<1 kDa) Ag in the AgNO3 -amended soils decreased with reaction half-lives of 4 to 22 days depending on the soil, denoting important Ag-ageing reactions...

BACKGROUND: Elevated metal ion levels have been associated with the presence of adverse local tissue reactions in patients with metal-on-polyethylene (MoP) total hip arthroplasty (THA) secondary to corrosion at head-neck taper junction. Patients are frequently concerned with their elevated systemic metal ion levels. This study investigated the rate of decline of serum cobalt and chromium ion levels after revision surgery. METHODS: A total of 39 patients with MoP THA were revised because of the presence of symptomatic adverse local tissue reactions on magnetic resonance imaging with elevated serum metal ion levels...

We describe 2 cases of articulation-related failures resulting in revision surgery after a Motec total wrist arthroplasty: one with an adverse reaction to metal debris and the other with an adverse reaction to polyether ether ketone. In the first patient, blood cobalt and chrome levels were elevated and magnetic resonance imaging showed clear signs of a pseudotumor. The other patient had an extensive release of polyether ether ketone particles into the surrounding synovia due to adverse wear conditions in the cup, leading to the formation of a fluid-filled cyst sac with a black lining and diffuse lymphocyte-dominated inflammation in the synovia...

Drug eruption is defined as an adverse cutaneous eruption secondary to drug intake. The most frequent variation is a morbilliform exanthema, although the clinical presentations may vary widely. The diagnosis is clinical, why thorough medical history and assessment are essential for the risk stratification of possible adverse cutaneous reaction. In Western hospitals, the prevalence is estimated to be 2-3% of the patients. Identification of the condition is therefore important for all healthcare professionals...

Background Recombinant human tripeptidyl peptidase 1 (cerliponase alfa) is an enzyme-replacement therapy that has been developed to treat neuronal ceroid lipofuscinosis type 2 (CLN2) disease, a rare lysosomal disorder that causes progressive dementia in children. Methods In a multicenter, open-label study, we evaluated the effect of intraventricular infusion of cerliponase alfa every 2 weeks in children with CLN2 disease who were between the ages of 3 and 16 years. Treatment was initiated at a dose of 30 mg, 100 mg, or 300 mg; all the patients then received the 300-mg dose for at least 96 weeks...

The pharmacokinetics (PK) and pharmacodynamics (PD) of bococizumab, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, were compared following a single 150-mg subcutaneous dose administered to healthy subjects (n = 156-158/arm) via: (1) a prefilled syringe (PFS) using drug substance (DS) manufactured by Pfizer, (2) a PFS using DS manufactured by Boehringer Ingelheim Pharma, (3) a prefilled pen using DS manufactured by Pfizer (NCT02458209). Blood samples were collected for 12 weeks postdose...

In recent years, cardiac patches have been developed for the treatment of myocardial infarction. However, the fixation approaches onto the tissue through suture or phototriggered reaction inevitably cause new tissue damage. Herein, a paintable hydrogel is constructed based on Fe3+ -triggered simultaneous polymerization of covalently linked pyrrole and dopamine in the hyperbranched chains where the in situ formed conductive polypyrrole also uniquely serves to crosslink network. This conductive and adhesive hydrogel can be conveniently painted as a patch onto the heart surface without adverse liquid leakage...

Baricitinib (Olumiant® ) is an oral, targeted synthetic DMARD that inhibits JAK1 and JAK2, which are implicated in the pathogenesis of rheumatoid arthritis (RA). This novel, small molecule is approved for use as monotherapy, or in combination with methotrexate, for the treatment of adults with moderate to severe active RA who responded inadequately to or were intolerant of ≥ 1 DMARD. In pivotal multinational trials, once-daily baricitinib 4 mg, with/without methotrexate (± another csDMARD), improved the signs and symptoms of RA, disease activity and physical function in DMARD-naive patients and in patients with an inadequate response to methotrexate, csDMARDs or TNF inhibitors; baricitinib treatment also slowed structural joint damage in DMARD-naive patients and in those with an inadequate response to methotrexate and csDMARDs...

Postoperative infection associated with medical implants is a devastating complication of orthopedic surgery. Considering the difficulties for the diagnosis and treatment of infection, coating the implant material with antibacterial substances is a promising protocol by which to avoid such an adverse reaction. Nanoparticles (NPs) constructed of anatase microspheres, one form of titanium dioxide (TiO2 ), with a high specific surface area are fabricated in this study in a facile one-step process using homogeneous precipitation at 90 °C under atmospheric pressure using titanium sulfate (Ti[SO4 ]2 ) and urea as the titanium source and precipitant, respectively...

All drugs have both favorable therapeutic and untoward adverse effects. Conventional opioid analgesics possess both analgesia and adverse reactions, such as nausea, vomiting, and respiratory depression. The opioid ligand binds to µ opioid receptor and non-selectively activates two intracellular signaling pathways: the G protein pathway induce analgesia, while the β-arrestin pathway is responsible for the opioid-related adverse reactions. An ideal opioid should activate the G protein pathway while deactivating the β-arrestin pathway...

Objectives: The aim of this study was to evaluate methotrexate (MTX) treatment administered by Polish rheumatologists in everyday practice. Material and methods: The study was based on a retrospective analysis of a cohort of 1957 patients with rheumatoid arthritis (RA). It was conducted among 100 rheumatologists, each of whom received 20 questionnaires and completed them based on the data from their rheumatoid arthritis patients. Results: Methotrexate was taken by 91% of patients, and 80% of them continued the treatment either as a monotherapy (65%) or concomitantly with other disease-modifying anti-rheumatic drugs...

BACKGROUND: Japan licensed the conjugate Haemophilus influenzae type b vaccine, Vaxem™ Hib, based on clinical studies using subcutaneous injection. The present study was performed to ensure this vaccine is suitable for intramuscular injection in Japanese children. METHODS: Thirty-one healthy 2-6-month-old infants received three doses of Vaxem™ Hib by intramuscular injection at 4-week intervals and a booster dose 1 year later, concomitant with routine infant (DTaP-IPV and pneumococcal) and toddler (measles-rubella) vaccines...

Tegretol® [carbamazepine (CBZ)], an aromatic drug approved for epilepsy treatment, can induce adverse drug reactions (ADRs) after its administration. Several genetic studies of epilepsy have shown that genetic polymorphisms increase the risk of ADRs, and some interactions between CBZ and other treatments can also induce adverse effects. Thus, to avoid such interactions and to provide an overview of the genetic profiles involved in ADRs with CBZ, for the first time, a systematic review and meta-analysis focusing on epilepsy was performed, using Cochrane Library, Embase and PubMed databases to find studies published between January 1980 and October 2016...

BACKGROUND: Thailand recommends influenza vaccination among pregnant women. We conducted a cohort study to determine if the prevalence of adverse events following immunization (AEFIs) with influenza vaccine among Thai pregnant women was similar to that often cited among healthy adults. METHODS: Women who were ≥17 gestational weeks and ≥18 years of age were recruited. Demographic and health history data were collected using structured questionnaires. Women were provided with symptom diary, ruler to measure local reaction(s), and thermometer to measure body temperature...

Autoimmune hepatitis (AH) is usually manifested as chronic hepatitis in clinics; it may evolve to liver cirrhosis, hepatic failure, and even death if treatment is delayed. To investigate the clinical efficacy of glucocorticoids in combination with ursodesoxycholic acid in the treatment of glucocorticoids in combination with ursodesoxycholic acid, one hundred and twenty patients with AH who were admitted to the hospital from February 2014 and February 2016 were selected and randomly divided into an observation group and a control group using random number table...

The most common adverse events associated with the monoclonal antibody alemtuzumab are infusion associated reactions and secondary autoimmune disease. Respiratory complications are unusual following treatment with alemtuzumab, but can be precipitated by an infectious cause. We describe a case of a sub-acute steroid responsive non-infectious pneumonitis affecting a 51 year old woman, who presented one month after initiation of therapy for multiple sclerosis with alemtuzumab.