Hydroxychloroquine safety in Covid-19 vs non-Covid-19 patients: analysis of differences and potential interactions.

Background: The use of hydroxychloroquine (HCQ) in the first COVID-19 epidemic wave raised safety concerns.

Research Design And Methods: Adverse reactions (ADR) suspected to be induced by HCQ and submitted to the Spanish Pharmacovigilance Database were studied. A disproportionality analysis was performed to determine adverse effects reported in non-Covid and Covid patients.

Haplotypes in the , and Genes and Biomarkers of Bone Mineral Metabolism in Older Adults.

Candidate gene studies have analyzed the effect of specific vitamin D pathway genes on vitamin D availability; however, it is not clear whether genetic variants also affect overall bone metabolism. This study evaluated the association between genetic polymorphisms in , and and serum levels of total 25(OH)D, iPTH and other mineral metabolism biomarkers (albumin, total calcium and phosphorus) in a sample of 273 older Spanish adults. We observed a significant difference between rs10741657 codominant model and total 25(OH)D levels after adjusting them by gender ( = 0.

A cross-sectional study of psychotropic drug use in the elderly: Consuming patterns, risk factors and potentially inappropriate use.

Objectives: The aims of the present study were: (1) to describe psychotropic drug consumption patterns in an outpatient population aged 65 years and older; (2) to determine the impact of a number of demographic and clinical factors on psychotropic consumption; and (3) to determine the ratio of potentially inappropriate psychotropic agents prescribed to the above population.

Methods: Cross-sectional, observational study of outpatients aged 65 years and older. Data on sociodemographic and clinical variables were collected.

Hydrochlorothiazide use and risk of non-melanoma skin cancer in Spain: A case/non-case study.

Objective: In 2018, the Pharmacological Risk Assessment Committee alerted to a potential relationship between accumulated hydrochlorothiazide dosage and the risk of non-melanoma skin cancer. To study this relationship we used data from the Spanish Pharmacovigilance System for Medicinal Products of Human Use.

Materials And Methods: Following a case search for every thiazide potentially associated with (SMQ/MedDRA) "Malignant Skin Neoplasms and not Otherwise Specified Skin Neoplasms", a series of disproportionality analyses were conducted by estimating the reporting odds ratio (95% confidence interval).

Medicines under additional monitoring in the European Union.

Objective: The objective of this study was to analyse the characteristics of  medicines subject to additional monitoring. We assessed the following aspects:  the criteria applied to approve a medicine as being subject to additional  monitoring; the authorized dispensing conditions; the pharmacological groups to which they belong; and their post-authorisation safety.

Method: We analysed the list published by the European Medicines Agency in  January 2017 (EMA/245297/2013 Rev.

Gastrointestinal safety of coxibs: systematic review and meta-analysis of observational studies on selective inhibitors of cyclo-oxygenase 2.

Prior meta-analyses have shown a higher gastrointestinal risk of nonselective NSAIDs versus placebo and a lower gastrointestinal risk of coxibs versus nonselective NSAIDs. However, the available data about gastrointestinal risk for coxibs versus placebo are scarce. The aim of this study was to review the current evidence on the use of coxibs and to evaluate the risk of gastrointestinal adverse outcomes (GAO) associated with coxibs versus nonexposed.

A polypharmacy risk prediction model for elderly patients based on sociodemographic and clinical factors.

Objective: Elderly people take increasing amounts of medication. The aim of our study was to determine the effects of different sociodemographic and clinical factors on polypharmacy and to develop a risk prediction model in outpatients aged 65 years and older.

Materials And Methods: Cross-sectional, observational, descriptive study of outpatients aged 65 years and older scheduled for a specialist visit.

Antipsychotics and cardiovascular risk: A case/non-case study.

Severe mental disorders have been reported to be associated with an increased cardiovascular risk. To measure the potential risk excess as compared, not with the baseline cardiovascular risk for the general population, but with the cardiovascular risk associated with drug iatrogenia. 197 reported cases of cardiovascular adverse reaction to antipsychotic drugs as compared to the reported cases of this type of adverse reactions to drugs other than antipsychotics entered in the Spanish Pharmacovigilance System database (FEDRA) (1995-2018) in an observational case/non-case study.

Cardiovascular Risk of Nonsteroidal Anti-inflammatory Drugs and Classical and Selective Cyclooxygenase-2 Inhibitors: A Meta-analysis of Observational Studies.

The purpose of this study was to review the published evidence on the clinical use of nonsteroidal anti-inflammatory drugs (NSAIDs) and to assess the cardiovascular risk (CVR) of cyclooxygenase-2 inhibitors (coxibs), excluding aspirin, by means of a meta-analytic procedure. A search was conducted on MEDLINE and EMBASE databases between October 1999 and June 2018. Cohort and case-control studies showing CVR as relative risk (RR), odds ratio, hazard ratio, or incidence rate ratio associated with NSAIDs versus no treatment were selected.

Cardiovascular and gastrointestinal safety of selective cyclooxygenase-2 inhibitors: a case/non-case study.

Background Coxibs cardiovascular (CV) safety continues being a current issue after rofecoxib worldwide withdrawal in 2004. Objective To evaluate the cardiovascular and gastrointestinal (GI) risk of coxibs through case/non-case study. Setting The Spanish Pharmacovigilance System for Human Use Drugs (FEDRA) and the Uppsala Monitoring Centre (VigiBase) databases.

New Anticoagulant Agents: Incidence of Adverse Drug Reactions and New Signals Thereof.

The aim of this study was to evaluate the adverse drug reaction (ADR) incidence rate and new signals thereof for classic compared with new anticoagulants in real-life ambulatory settings. The authors performed an observational cross-sectional study in two cohorts of surveyed patients treated with vitamin K antagonists (VKAs; acenocoumarol or warfarin) or nonvitamin K antagonist oral anticoagulants (NOACs; apixaban, edoxaban, rivaroxaban, dabigatran etexilate). Descriptive, clinical, and ADRs data were reported and analyzed through a bivariate analysis (odds ratio [OR]) to compare the ADRs incidence rate and an adaptation of Bayesian methodology (false discovery rate [FDR] < 0.

What can we learn from the public's understanding of drug information and safety? A population survey.

Objective: The aim of our study was to analyse the perceptions of the public on medicine information and safety and on consumer reporting of suspected adverse drug reactions (ADR).

Methods: A voluntary survey was conducted in a population ≥18 years of age in Asturias, a region in northern Spain. The survey was designed to be completed in a face-to-face street interview or completed independently by the public.

Atypical Fracture of the Sternum After Long-Term Alendronate Plus Cholecalciferol Treatment: A Case Report.

A 55-year-old woman developed an atraumatic sternum fracture during treatment with alendronate for osteoporosis. The woman received alendronate 70 mg in combination with cholecalciferol 5600 IU once weekly, as well as nonsteroidal anti-inflammatory drugs. After 4 years of treatment, following a dorsal flexion with no direct thoracic trauma, the patient suffered a fracture of the sternum, with an X-ray revealing sternal body fracture.

Risk excess of mortality and use of antipsychotics: a case-noncase study.

Severe mental disorders are associated with an increased mortality risk and the use of antipsychotic drugs may be one of the causes. In this study, we addressed the potential association of the reported mortality among patients on antipsychotics compared to other drugs from a pharmacovigilance database with the aim of evaluating the drug-induced mortality risk. A database containing 189 441 entries of suspected adverse reactions reported from 1 January 1995 to 31 December 2012 was explored for fatal outcomes.

Carpal Tunnel Syndrome Associated with Oral Bisphosphonates. A Population-Based Cohort Study.

Background: Bisphosphonates are widely used to prevent osteoporotic fractures. Some severe musculoskeletal reactions have been described with this medication; among them, some cases of carpal tunnel syndrome. Thus, the aim of this study was to explore whether bisphosphonates may be associated with this syndrome.

Emergency contraceptive pill safety profile. Comparison of the results of a follow-up study to those coming from spontaneous reporting.

Background: The emergency contraceptive pill (ECP) containing levonorgestrel is dispensed without a prescription in Spain since 2009. An easy access could diminish unwanted pregnancies; however, there is a risk of misuse and, in any case, of developing some adverse events. The aim of the present study is to further learn the adverse effects of this ECP.

Trends in the consumption of attention deficit hyperactivity disorder medications in Castilla y León (Spain): changes in the consumption pattern following the introduction of extended release methylphenidate.

Background: Attention deficit hyperactivity disorder (ADHD) is the most diagnosed behavioural disorder in children and adolescents; prevalence has been estimated around 5%. Studies have shown an increase in the use of ADHD medications during the last years. The aim of the present study was to learn the pattern and the evolution of ADHD medication consumption in Castilla y León (Spain).

Gynaecomastia associated with proton pump inhibitors: a case series from the Spanish Pharmacovigilance System.

Objective: Proton pump inhibitors (PPIs) are widely used in the management of peptic ulcer and related symptoms. They have been linked to certain endocrine adverse reactions, including gynaecomastia. The aim of the present study is to investigate the association between the use of PPIs and the development of gynaecomastia.

HMG CoA reductase inhibitors and impotence: two case series from the Spanish and French drug monitoring systems.

Objective: HMG CoA Reductase inhibitors, more commonly called statins, are used in the pharmacological management of hyperlipidaemia. At present, the use of these drugs is increasing worldwide. They have been linked to certain adverse drug reactions, including impotence.

Gastroprotection during the administration of non-steroidal anti-inflammatory drugs. A drug-utilization study.

There has been an increase of anti-ulcer drug consumption in Spain. A high proportion of this consumption may be due to the use of those drugs as gastroprotective agents when co-prescribed with non-steroidal anti-inflammatory drugs (NSAIDs). The aim of this study was to learn how these treatments are being used: the prevalence of use, the type of drug and the main features of patients.