scholarly journals Common osteoporosis drug associated with increased rates of depression and anxiety

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Dro Keshishi ◽  
Tigran Makunts ◽  
Ruben Abagyan
Keyword(s):  
Depressive Symptoms ◽  
Adverse Events ◽  
Reporting System ◽  
Case Reports ◽  
Bisphosphonate Therapy ◽  
World Health ◽  
Depression And Anxiety ◽  
First Line ◽  
Global Database ◽  
Osteoporosis Drug

AbstractOsteoporosis affects over 10 million Americans over 50. Bisphosphonate therapy, mainly alendronate, is amongst the most prescribed treatments for the disease. The use of alendronate and other bisphosphonates has been associated with depressive symptoms in recent case reports. In this study we quantified this association by analyzing over 100,000 adverse events reports from the Food and Drug Administration Adverse Events Reporting System (FAERS) and the World Health Organization’s (WHO) global database for adverse drug reactions, ADRs, VigiAccess. We found that alendronate therapy is significantly associated with depression and anxiety when compared to other first-line osteoporosis treatments. The reported risk of depressive ADRs was found to be over 14-fold greater in patients taking alendronate under the age of 65 and over fourfold greater for patients over 65 compared to the control. Several hypotheses concerning the molecular mechanism of the observed association of alendronate and depressive symptoms were discussed.

Real-world risk of anosmia with cancer directed systemic therapy: A pharmacovigilance assessment using FDA Adverse Events Reporting System (FAERS) database.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18790-e18790
Author(s):  
Anahat Kaur ◽  
Shuai Wang ◽  
Arlene Yu ◽  
Tarek N. Elrafei ◽  
Lewis Steinberg ◽  
...  
Keyword(s):  
Adverse Events ◽  
Reporting System ◽  
Case Reports ◽  
Descriptive Analysis ◽  
Package Insert ◽  
Case Series ◽  
The United States ◽  
Chemotherapeutic Agents ◽  
United States Food ◽  
Pharmacovigilance Database

e18790 Background: Anosmia is a rare and under-reported adverse event associated with the use of several oncologic drugs. Instances of olfactory disturbances following administration of chemotherapeutic agents have been sporadically documented in case reports and case series. We aimed to conduct a more comprehensive study to generate signal for anosmia as adverse effect of drugs used for oncologic indications. Methods: The United States Food and Drug Administration (FDA) Adverse Events Reporting System (FAERS) database, a pharmacovigilance database, was used to extract data. All reported cases of anosmia in the database were filtered for an indication of cancer. Descriptive analysis was conducted using SPSS 26. Results: Total 10250 cases of anosmia were extracted from FAERS database. Out of these, cancer as an indication for medication use was noted in 139 cases. Some of the most common suspect medications exclusively associated with more than one case of anosmia were palbociclib (n=16), enzalutamide (13), pazopanib (8), cabozantinib (8), letrozole (6), leuprolide (5), niraparib (5), rucaparib (4), tamoxifen (4), capecitabine (3), everolimus (3), anastrazole (2), exemestane (2), zoledronic acid (2), vandetanib (2) and vismodegib (2). Detailed description of medications with highest number of reported cases is listed in Table. Median age at diagnosis was 66 years (interquartile range 58-71). Anosmia was reported more commonly in females (64% ) as compared to males (33.8%). Reactions were reported to the FDA more commonly by consumers (56.8%) as compared to healthcare professionals (40.3% cases). Out of 139 patients with anosmia, 93 (66.9%) had concomitant ageusia, 8 (5.7 %) had dysgeusia and 6 (4.3%) patients had neuropathy. Conclusions: This study demonstrates a signal for anosmia as side effect in patients receiving select oncologic medications based on the FAERS database. It is worth noting that none of the suspect medications identified in this study have anosmia listed as known adverse reaction on accompanying package insert. Further studies need to be conducted to confirm if causal relationship exists between use of these drugs and olfactory function compromise. [Table: see text]

California rocket fuel: And what about being a first line treatment?

2016 ◽  
Vol 33 (S1) ◽  
pp. S551-S551
Author(s):  
J. Silva ◽  
J. Mota ◽  
P. Azevedo
Keyword(s):  
Case Report ◽  
Depressive Symptoms ◽  
Case Reports ◽  
Drug Resistant ◽  
Line Treatment ◽  
First Line ◽  
Depressed Woman ◽  
Rocket Fuel ◽  
Resistant Depression ◽  
First Line Treatment

IntroductionThe association venlafaxine-mirtazapine is currently known as California Rocket Fuel (CRF). Studies show advantage in terms of efficacy and rapid control of depressive symptoms compared to other associations. Venlafaxine is a selective serotonin-noradrenalin reuptake inhibitor and mirtazapine is a noradrenergic-specific serotonergic antidepressant: the result is a potent noradrenergic and serotonergic effect. Studies say that CRF should be performed only for drug-resistant depression; however, there are case reports of its use as a first line treatment, in selected patients.ObjectivesTo summarize the latest literature about this field and to present a case report.AimTo explore and critically review the controversies of venlafaxine-mirtazapine association as a first line antidepressants strategy.MethodsA brief review of the latest literature was performed, using PubMed and the keywords “venlafaxine-mirtazapine association”. A case report about a depressed woman is presented.ResultsDespite most studies are referent to its utility in drug-resistant depression, there are recent pilot studies that recommend CRF as a first line option.M., a 64-year-old woman, had her first psychiatric consultation. She had been depressed for 2 years, she lost 10 kg, had total insomnia and suicidal thoughts. CRF was started up to 150/15 mg, daily. An improvement was noticed after two weeks of treatment and the stabilization of depressive symptoms were achieved by the fourth month.ConclusionsCRF seems to be effective and useful. Patients with insomnia and weight loss may benefit from CRF as a first line option. However, more studies are needed.Disclosure of interestThe authors have not supplied their declaration of competing interest.

scholarly journals d4T: keep it or abandon it?

2010 ◽  
Vol 4 (4) ◽  
pp. 541-546 ◽  
Author(s):  
Andrew Hill
Keyword(s):  
Body Weight ◽  
Adverse Events ◽  
World Health ◽  
Nucleoside Analogues ◽  
Line Treatment ◽  
First Line ◽  
The World ◽  
Dose Ranging ◽  
Health Organization ◽  
First Line Treatment

Abstract Stavudine is a nucleoside analogue used widely for first-line treatment of HIV in developing and middleincome countries. The World Health Organization recommended that all patients should switch to stavudine (30mg BID). However, there is evidence from the dose-ranging trials that patients with body weight below 60kg should use a dose of 20mg BID. For patients who show adverse events on stavudine, a switch to other nucleoside analogues can be considered. This article reviews d4T to study if it should be kept or abandoned.

scholarly journals Drug-Associated Delirium Identified in The Food and Drug Administration Adverse Events Reporting System

2019 ◽  
pp. 1-7
Author(s):  
Adrian Wong ◽  
Angela Li ◽  
Kane Gill ◽  
Matthew P. Gray ◽  
Pamela L. Smithburger ◽  
...  
Keyword(s):  
Adverse Events ◽  
Drug Administration ◽  
Reporting System ◽  
Case Reports ◽  
Food And Drug Administration ◽  
Public Knowledge ◽  
Future Studies ◽  
The Public ◽  
Post Marketing Surveillance ◽  
Post Marketing

Introduction: Drug toxicity and polypharmacy are major risk factors for delirium, especially in older adult patients with underlying comorbidities. However, numerous case reports have described drugs with a lower suspicion of being deliriogenic. The objective of this study was to identify deliriogenic drugs in the Food and Drug Administration Adverse Events Reporting System (FAERS) to broaden the public knowledge and understanding. Study Design: Retrospective pharmacovigilance evaluation. Methods: FAERS reports from 2004 through 2015 were reviewed for delirium-associated terms, which were utilized to identify drugs most frequently reported to cause delirium. Drugs were categorized as: 1) known to be deliriogenic; 2) potentially deliriogenic; or 3) new potential to be deliriogenic. The 100 most frequently reported drugs were analyzed in reporting odds ratios (ROR). Results: Of the known deliriogenic drugs (n=32), paroxetine (ROR 4.1, CI 4.0-4.3), olanzapine (ROR 3.3, CI 3.2-3.4), and clozapine (ROR 2.9, CI 2.8-3.0) were most reported. Of the potentially deliriogenic drugs (n=54), duloxetine (ROR 3.2, CI 3.1-3.3), varenicline (ROR 3.1, CI 3.0-3.2), and gabapentin (ROR 2.9, CI 2.7-3.0) were most reported. Three drugs were considered to have new potential to be deliriogenic: heparin (ROR 1.5, CI 1.4-1.6), metformin (ROR 1.3, CI 1.3-1.4), and dalfampridine (ROR 1.1, CI 1.1-1.2). Conclusion: The majority of drugs were considered potentially deliriogenic. FAERS can provide post-marketing surveillance data to guide future studies on potentially deliriogenic drugs to guide management of causal agents.

scholarly journals Acute Renal Failure in a Patient with Rivaroxaban-Induced Hypersensitivity Syndrome: A Case Report with a Review of the Literature and of Pharmacovigilance Registries

2020 ◽  
Vol 2020 ◽  
pp. 1-6
Author(s):  
Gisela Marcelino ◽  
Ould Maouloud Hemett ◽  
Eric Descombes
Keyword(s):  
Renal Failure ◽  
Acute Renal Failure ◽  
Adverse Events ◽  
Case Reports ◽  
Vitamin K Antagonists ◽  
Clinical Manifestations ◽  
Hypersensitivity Syndrome ◽  
World Health ◽  
Low Grade ◽  
Review Of The Literature

Direct oral anticoagulants (DOACs) are among the most commonly prescribed medications, and DOAC-associated kidney dysfunction may be a problem that is underrecognized by clinicians. We report on the case of an 82-year-old patient who, two weeks after the prescription of rivaroxaban for atrial fibrillation, was hospitalized for a drug-induced hypersensitivity syndrome whose main clinical manifestations were low-grade fever with a petechial rash in the legs and acute renal failure (ARF). Within one week after rivaroxaban withdrawal, the patient’s clinical condition improved and the renal function normalized. In a review of the literature, we only found five case reports of rivaroxaban-related ARF: two patients had tubulo-interstitial nephritis (TIN), two had anticoagulant-related nephropathy (ARN), and the last one had IgA nephropathy. As some recent publications suggest that kidney injury due to anticoagulation drugs may be largely underdiagnosed, we also analyzed the data from the VigiAccess database, the World Health Organization pharmacovigilance program that collects drug-related adverse events from 134 national registries worldwide. Among all the rivaroxaban-associated adverse events reported in VigiAccess since 2006, 4,323 (3.5%) were renal side effects, of which 2,351 (54.3%) were due to unspecified ARF, 363 (8.4%) were due to renal hemorrhage (characteristically associated with ARN), and 24 (0.6%) were due to TIN. We also compared these results with those reported in VigiAccess for other DOACs and vitamin K antagonists. This analysis suggests that the frequency of renal adverse events associated with rivaroxaban and other DOACs may be appreciably higher than what one might currently consider based only on the small number of fully published cases.

Cathartic Effect of Suicide Attempts Not Limited to Depression

Crisis ◽  
2003 ◽  
Vol 24 (2) ◽  
pp. 73-78 ◽  
Author(s):  
Yves Sarfati ◽  
Blandine Bouchaud ◽  
Marie-Christine Hardy-Baylé
Keyword(s):  
Quality Of Life ◽  
Depressive Symptoms ◽  
Personality Traits ◽  
Rating Scales ◽  
Suicide Attempts ◽  
World Health ◽  
Life Questionnaire ◽  
Short Term

Summary: The cathartic effect of suicide is traditionally defined as the existence of a rapid, significant, and spontaneous decrease in the depressive symptoms of suicide attempters after the act. This study was designed to investigate short-term variations, following a suicide attempt by self-poisoning, of a number of other variables identified as suicidal risk factors: hopelessness, impulsivity, personality traits, and quality of life. Patients hospitalized less than 24 hours after a deliberate (moderate) overdose were presented with the Montgomery-Asberg Depression and Impulsivity Rating Scales, Hopelessness scale, MMPI and World Health Organization's Quality of Life questionnaire (abbreviated versions). They were also asked to complete the same scales and questionnaires 8 days after discharge. The study involved 39 patients, the average interval between initial and follow-up assessment being 13.5 days. All the scores improved significantly, with the exception of quality of life and three out of the eight personality traits. This finding emphasizes the fact that improvement is not limited to depressive symptoms and enables us to identify the relative importance of each studied variable as a risk factor for attempted suicide. The limitations of the study are discussed as well as in particular the nongeneralizability of the sample and setting.

Adverse Events Reporting System as Experienced by Critical-Care Nurses in KwaZulu-Natal, South Africa

2018 ◽  
Vol 20 (1) ◽  
Author(s):  
Thusile Mabel Gqaleni ◽  
Busisiwe Rosemary Bhengu
Keyword(s):  
South Africa ◽  
Critical Care ◽  
Adverse Events ◽  
Patient Care ◽  
Family Involvement ◽  
Reporting System ◽  
Legal Framework ◽  
Critical Care Nurses ◽  
Kwazulu Natal ◽  
Life Threatening

Critically ill patients admitted to critical-care units (CCUs) might have life-threatening or potentially life-threatening problems. Adverse events (AEs) occur frequently in CCUs, resulting in compromised quality of patient care. This study explores the experiences of critical-care nurses (CCNs) in relation to how the reported AEs were analysed and handled in CCUs. The study was conducted in the CCUs of five purposively selected hospitals in KwaZulu-Natal, South Africa. A descriptive qualitative design was used to obtain data through in-depth interviews from a purposive sample of five unit managers working in the CCUs to provide a deeper meaning of their experiences. This study was a part of a bigger study using a mixed-methods approach. The recorded qualitative data were analysed using Tesch’s content analysis. The main categories of information that emerged during the data analysis were (i) the existence of an AE reporting system, (ii) the occurrence of AEs, (iii) the promotion of and barriers to AE reporting, and (iv) the handling of AEs. The findings demonstrated that there were major gaps that affected the maximum utilisation of the reporting system. In addition, even though the system existed in other institutions, it was not utilised at all, hence affecting quality patient care. The following are recommended: (1) a non-punitive and non-confrontational system should be promoted, and (2) an organisational culture should be encouraged where support structures are formed within institutions, which consist of a legal framework, patient and family involvement, effective AE feedback, and education and training of staff.

Novel Adverse Events of Iloperidone: A Disproportionality Analysis in US Food and Drug Administration Adverse Event Reporting System (FAERS) Database

2019 ◽  
Vol 14 (1) ◽  
pp. 21-26 ◽  
Author(s):  
Viswam Subeesh ◽  
Eswaran Maheswari ◽  
Hemendra Singh ◽  
Thomas Elsa Beulah ◽  
Ann Mary Swaroop
Keyword(s):  
Data Mining ◽  
Adverse Event ◽  
Adverse Events ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Disproportionality Analysis ◽  
Positive Signal ◽  
Data Mining Algorithms ◽  
Mining Algorithms

Background: The signal is defined as “reported information on a possible causal relationship between an adverse event and a drug, of which the relationship is unknown or incompletely documented previously”. Objective: To detect novel adverse events of iloperidone by disproportionality analysis in FDA database of Adverse Event Reporting System (FAERS) using Data Mining Algorithms (DMAs). Methodology: The US FAERS database consists of 1028 iloperidone associated Drug Event Combinations (DECs) which were reported from 2010 Q1 to 2016 Q3. We consider DECs for disproportionality analysis only if a minimum of ten reports are present in database for the given adverse event and which were not detected earlier (in clinical trials). Two data mining algorithms, namely, Reporting Odds Ratio (ROR) and Information Component (IC) were applied retrospectively in the aforementioned time period. A value of ROR-1.96SE>1 and IC- 2SD>0 were considered as the threshold for positive signal. Results: The mean age of the patients of iloperidone associated events was found to be 44years [95% CI: 36-51], nevertheless age was not mentioned in twenty-one reports. The data mining algorithms exhibited positive signal for akathisia (ROR-1.96SE=43.15, IC-2SD=2.99), dyskinesia (21.24, 3.06), peripheral oedema (6.67,1.08), priapism (425.7,9.09) and sexual dysfunction (26.6-1.5) upon analysis as those were well above the pre-set threshold. Conclusion: Iloperidone associated five potential signals were generated by data mining in the FDA AERS database. The result requires an integration of further clinical surveillance for the quantification and validation of possible risks for the adverse events reported of iloperidone.

scholarly journals The Association between Ranitidine Use and Gastrointestinal Cancers

Cancers ◽  
2020 ◽  
Vol 13 (1) ◽  
pp. 24
Author(s):  
Gerald McGwin
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Reporting System ◽  
Large Body ◽  
Science Research ◽  
Gastrointestinal System ◽  
Gastrointestinal Cancers ◽  
H2 Antagonists ◽  
Study Results ◽  
Risk Of Cancer

N-nitrosodimethylamine (NDMA) is a carcinogen in experimental animals. It has been classified a probable human carcinogen and has been found in ranitidine. This study sought to evaluate the association between ranitidine use and cancer of the gastrointestinal system. Events reported to the FDA Adverse Events Reporting System that were associated with the use of proton pump inhibitors (PPIs) and H2 antagonists were selected. Proportionate reporting ratios (PRRs) and associated 95% confidence intervals (CIs) were calculated to compare the proportion of all reported adverse events that were for gastrointestinal system cancers among adverse event reports for ranitidine to adverse event reports for other H2 antagonists. The proportion of adverse events for any gastrointestinal system cancer relative to all other events was elevated for ranitidine compared to PPIs and other H2 antagonists (PRR 3.66, 95% CI 3.19–4.20). Elevated and significant PRRs were observed for pharyngeal (PRR 9.24), esophageal (PRR 3.56), stomach (PRR 1.48), colorectal (PRR 16.31), liver (PRR 2.64), and pancreatic (PRR 2.18) cancers. The PRRs for anal (PRR 4.62) and gallbladder (PRR 4.62) cancer were also elevated though not statistically significant. In conjunction with a large body of epidemiologic and human and animal basic science research, the study results support the hypothesis that NDMA-contaminated ranitidine increases the risk of cancer and supports the withdrawal of these medications from the market.

scholarly journals The Safety and Effect of Local Botulinumtoxin A Injections for Long-Term Management of Chronic Pain in Post-Herpetic Neuralgia: Literature Review and Cases Report Treated with Incobotulinumtoxin A

2021 ◽  
Vol 11 (8) ◽  
pp. 758
Author(s):  
Songjin Ri ◽  
Anatol Kivi ◽  
Jörg Wissel
Keyword(s):  
Chronic Pain ◽  
Neuropathic Pain ◽  
Adverse Events ◽  
Case Reports ◽  
Pain Reduction ◽  
Post Herpetic Neuralgia ◽  
Botulinumtoxin A ◽  
Incobotulinumtoxin A ◽  
Term Management

There are few reports on the safety and effectiveness of long-term botulinumtoxin A (BoNT A) therapy in severe chronic pain of post-herpetic neuralgia (PHN). The literature was searched with the term “neuropathic pain” and “botulinum” on PubMed (up to 29 February 2020). Pain was assessed with the Visual Analogue Scale (VAS) before and after BoNT A therapy. A total of 10 clinical trials and six case reports including 251 patients with PHN were presented. They showed that BoNT A therapy had significant pain reduction (up to 30–50%) and improvement in quality of life. The effect duration seems to be correlated with BoNT A doses injected per injection site. Intervals between BoNT A injections were 10–14 weeks. No adverse events were reported in cases and clinical studies, even in the two pregnant women, whose babies were healthy. The repeated (≥6 times) intra/subcutaneous injections of incobotulinumtoxin A (Xeomin®, Merz Pharmaceuticals, Germany) over the two years of our three cases showed marked pain reduction and no adverse events. Adjunctive local BoNT A injection is a promising option for severe PHN, as a safe and effective therapy in long-term management for chronic neuropathic pain. Its effect size and -duration seem to be depended on the dose of BoNT A injected per each point.

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