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Expert Opinion on Drug Safety Jun 2024The existing evidence from pre- and post-marketing studies is conflicting on the risk of pancreatic events for anti-diabetic medications. (Meta-Analysis)
Meta-Analysis
Risk of pancreatitis and pancreatic carcinoma for anti-diabetic medications: findings from real-world safety data analysis and systematic review and meta-analysis of randomized controlled trials.
BACKGROUND
The existing evidence from pre- and post-marketing studies is conflicting on the risk of pancreatic events for anti-diabetic medications.
RESEARCH DESIGN AND METHODS
A retrospective case/non-case study was conducted by using spontaneous reports on pancreatic events for anti-diabetic medications from the FDA Adverse Event Reporting System (FAERS) and VigiBase. Proportional Reporting Ratio (PRR), Reporting Odds Ratio (ROR), and Information Component (IC) were calculated by a disproportionality analysis. Furthermore, PubMed, Google Scholar, Scopus, and ClinicalTrials.gov were systematically searched for randomized controlled trials (RCTs) on anti-diabetic drugs with pancreatic outcomes.
RESULTS
The FAERS data analysis found strong signals on incretin mimetics causing pancreatic events, with sitagliptin having the highest risk [PRR = 24.2, lower bound (LB) ROR = 24.4, IC = 4.4 for pancreatitis, and PRR = 15.4, LB ROR = 14.9, IC = 3.8 for pancreatic carcinoma]. Empagliflozin was the most pancreatitis-risk sodium-glucose co-transporter-2 inhibitor [PRR = 4.0, LB ROR = 3.5, IC = 1.8]. VigiBase reiterated these findings and identified some new signals for novel anti-diabetics. Meta-analysis revealed that the incidence of pancreatitis and pancreatic carcinoma with anti-diabetic medications was insignificant. However, compared to the placebo/active comparator, gliptins had a higher risk of acute pancreatitis (OR 1.44; 95% CI 1.03, 2.01; = 0.03).
CONCLUSION
Evidence from the post-marketing safety data analysis identified a strong association between incretin mimetics and pancreatic events. Fewer events in RCTs may justify insignificant meta-analysis results.
Topics: Humans; Pancreatic Neoplasms; Pancreatitis; Randomized Controlled Trials as Topic; Hypoglycemic Agents; Adverse Drug Reaction Reporting Systems; Retrospective Studies; Risk; Sodium-Glucose Transporter 2 Inhibitors
PubMed: 37986140
DOI: 10.1080/14740338.2023.2284992 -
Expert Opinion on Drug Safety Oct 2016To perform a systematic review of studies describing paediatric adverse drug reactions (ADRs) conducted from national pharmacovigilance databases. (Review)
Review
OBJECTIVE
To perform a systematic review of studies describing paediatric adverse drug reactions (ADRs) conducted from national pharmacovigilance databases.
METHODS
A systematic literature search of studies describing results for paediatric ADRs from national pharmacovigilance databases was performed. PubMed database, Embase and MEDLINE were searched up to March 2015. The descriptive studies included were analysed for country of origin, reporters, and ADR reporting rate, drugs, ADRs and number of fatalities.
RESULTS
20 studies were identified. Doctors were the largest group of reporters in all the studies, and with more consumer reports seen in USA. The studies ranged from 3 - 37 years. The highest ADR reporting rate was 1458 reports per year per million children in Cuba. Antibiotics and vaccines were the most frequently reported drugs, in almost all the studies. The most frequent ADRs were skin and nervous system disorders. The highest proportion of fatalities and serious reports was from North America. Drugs used for treating attention deficit hyperactivity disorders (ADHD) and isotretinoin were the most frequently reported drugs for ADRs in North America.
CONCLUSIONS
There were geographical differences in drugs responsible for ADRs and their seriousness, especially in North America. Very few studies were conducted in Asia and Latin America, none were found from Africa.
Topics: Adverse Drug Reaction Reporting Systems; Child; Databases, Factual; Drug-Related Side Effects and Adverse Reactions; Humans; Pharmacovigilance
PubMed: 27501085
DOI: 10.1080/14740338.2016.1221921 -
Sexual Medicine Reviews Jul 2021Information about the possible effects of cutaneous immune-mediated diseases (cIMDs) on male sexual function and reproduction is scarce. Factors known to impair sexual... (Review)
Review
INTRODUCTION
Information about the possible effects of cutaneous immune-mediated diseases (cIMDs) on male sexual function and reproduction is scarce. Factors known to impair sexual health and reproduction, such as inflammation, medication use, and hypogonadism, can be present in a significant proportion of male patients with cIMD.
OBJECTIVES
To systematically review the literature for the influence of paternal cIMD on many aspects of male sexual and reproductive health, such as sexual function, reproductive hormones, fertility, and pregnancy and offspring outcomes.
METHODS
A systematic literature search was performed. The searches combined keywords regarding male sexual function and fertility, pregnancy outcomes, and offspring's health with a list of cIMDs.
RESULTS
The majority of the identified studies included patients with psoriasis (22 of 27), and sexual function was the most common outcome of interest (20 of 27). For patients diagnosed with psoriasis, the prevalence of male sexual dysfunction reported in these studies ranged from 34 to 81%. Hypogonadism in patients with psoriasis was reported in 2 of 3 studies. Sperm analysis abnormalities in patients with psoriasis were reported in 3 of 4 studies. No information about the effect of paternal disease on pregnancy and offspring outcomes was identified.
CONCLUSIONS
Disease activity in psoriasis might play an important role in the development of sexual dysfunction, hypogonadism, and abnormal sperm quality. For the other cIMD included in this review, there is insufficient information regarding male sexual and reproductive health to draw firm conclusions. More research is needed to understand the association between cIMD and impaired male sexual and reproductive health. Perez-Garcia LF, Dolhain R, te Winkel B, et al. Male Sexual Health and Reproduction in Cutaneous Immune-Mediated Diseases: A Systematic Review. Sex Med Rev 2021;9:423-433.
Topics: Female; Fertility; Humans; Infertility, Male; Male; Pregnancy; Pregnancy Outcome; Sexual Dysfunction, Physiological; Sexual Health
PubMed: 32883623
DOI: 10.1016/j.sxmr.2020.07.004 -
British Journal of Clinical Pharmacology Jul 2016Adverse drug events (ADEs) are harmful and unintended consequences of medications. Their reporting is essential for drug safety monitoring and research, but it has not... (Review)
Review
AIM
Adverse drug events (ADEs) are harmful and unintended consequences of medications. Their reporting is essential for drug safety monitoring and research, but it has not been standardized internationally. Our aim was to synthesize information about the type and variety of data collected within ADE reporting systems.
METHODS
We developed a systematic search strategy, applied it to four electronic databases, and completed an electronic grey literature search. Two authors reviewed titles and abstracts, and all eligible full-texts. We extracted data using a standardized form, and discussed disagreements until reaching consensus. We synthesized data by collapsing data elements, eliminating duplicate fields and identifying relationships between reporting concepts and data fields using visual analysis software.
RESULTS
We identified 108 ADE reporting systems containing 1782 unique data fields. We mapped them to 33 reporting concepts describing patient information, the ADE, concomitant and suspect drugs, and the reporter. While reporting concepts were fairly consistent, we found variability in data fields and corresponding response options. Few systems clarified the terminology used, and many used multiple drug and disease dictionaries such as the Medical Dictionary for Regulatory Activities (MedDRA).
CONCLUSION
We found substantial variability in the data fields used to report ADEs, limiting the comparability of ADE data collected using different reporting systems, and undermining efforts to aggregate data across cohorts. The development of a common standardized data set that can be evaluated with regard to data quality, comparability and reporting rates is likely to optimize ADE data and drug safety surveillance.
Topics: Adverse Drug Reaction Reporting Systems; Databases, Factual; Drug-Related Side Effects and Adverse Reactions; Humans; Pharmacovigilance
PubMed: 27016266
DOI: 10.1111/bcp.12944 -
Pharmacological Research May 2024Patients with chronic kidney disease (CKD) often experience mild cognitive impairment and other neurocognitive disorders. Studies have shown that erythropoietin (EPO)... (Review)
Review
Patients with chronic kidney disease (CKD) often experience mild cognitive impairment and other neurocognitive disorders. Studies have shown that erythropoietin (EPO) and its receptor have neuroprotective effects in cell and animal models of nervous system disorders. Recombinant human EPO (rHuEPO), commonly used to treat anemia in CKD patients, could be a neuroprotective agent. In this systematic review, we aimed to assess the published studies investigating the cognitive benefits of rHuEPO treatment in individuals with reduced kidney function. We comprehensively searched Pubmed, Cochrane Library, Scopus, and Web of Science databases from 1990 to 2023. After selection, 24 studies were analyzed, considering study design, sample size, participant characteristics, intervention, and main findings. The collective results of these studies in CKD patients indicated that rHuEPO enhances brain function, improves performance on neuropsychological tests, and positively affects electroencephalography measurements. These findings suggest that rHuEPO could be a promising neuroprotective agent for managing CKD-related cognitive impairment.
Topics: Humans; Erythropoietin; Neuroprotective Agents; Renal Insufficiency, Chronic; Cognitive Dysfunction; Animals; Recombinant Proteins; Brain; Cognition
PubMed: 38493928
DOI: 10.1016/j.phrs.2024.107146 -
Multiple Sclerosis (Houndmills,... Apr 2023Data are sparse regarding the safety of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines in patients with multiple sclerosis (MS). (Meta-Analysis)
Meta-Analysis
BACKGROUND
Data are sparse regarding the safety of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines in patients with multiple sclerosis (MS).
OBJECTIVE
To estimate (1) the pooled proportion of MS patients experiencing relapse among vaccine recipients; (2) the rate of transient neurological worsening, adverse events, and serious adverse events; (3) the previous outcomes of interest for different SARS-CoV-2 vaccine types.
METHODS
Systematic review and meta-analysis of pharmacovigilance registries and observational studies.
RESULTS
Nineteen observational studies comprising 14,755 MS patients who received 23,088 doses of COVID-19 vaccines were included. Mean age was 43.3 years (95% confidence interval (CI): 40-46.6); relapsing-remitting, secondary-progressive, primary-progressive MS and clinically isolated syndrome were diagnosed in 82.6% (95% CI: 73.9-89.8), 12.6% (95% CI: 6.3-20.8), 6.7% (95% CI: 4.2-9.9), and 2.9% (95% CI: 1-5.9) of cases, respectively. The pooled proportion of MS patients experiencing relapse at a mean time interval of 20 days (95% CI: 12-28.2) from vaccination was 1.9% (95% CI: 1.3%-2.6%; = 78%), with the relapse risk being independent of the type of administered SARS-CoV-2-vaccine ( for subgroup differences = 0.7 for messenger RNA (mRNA), inactivated virus, and adenovector-based vaccines). After vaccination, transient neurological worsening was observed in 4.8% (95% CI: 2.3%-8.1%) of patients. Adverse events and serious adverse events were reported in 52.8% (95% CI: 46.7%-58.8%) and 0.1% (95% CI: 0%-0.2%) of vaccinations, respectively.
CONCLUSION
COVID-19 vaccination does not appear to increase the risk of relapse and serious adverse events in MS. Weighted against the risks of SARS-CoV-2-related complications and MS exacerbations, these safety data provide compelling pro-vaccination arguments for MS patients.
Topics: Adult; Humans; COVID-19; COVID-19 Vaccines; Multiple Sclerosis; SARS-CoV-2; Vaccination
PubMed: 36722184
DOI: 10.1177/13524585221150881 -
Expert Opinion on Drug Safety Nov 2018Social media mining could be a possible strategy to retrieve drug safety information. The mining of social media is a complex process under progressive evolution,... (Review)
Review
Social media mining could be a possible strategy to retrieve drug safety information. The mining of social media is a complex process under progressive evolution, falling into three broad categories: listening (safety data reporting), engaging (follow-up), and broadcasting (risk communication). This systematic review is aimed at evaluating the usefulness and quality of proto-signals by social media listening. Areas covered: In this systematic search, performed according to MOOSE and PRISMA statements, we selected studies, published in MEDLINE, EMBASE, and Google Scholar until 31 December 2017, that listened at least one social media to identify proto-adverse drug events and proto-signals. Expert opinion: The selected 38 studies identified serious and unexpected proto-adverse drug events characterized by poorer information quality as compared with spontaneous reporting databases. This feature allows rarely the evaluation of causal relationships. Proto-signals identified by social media listening had the potential of anticipating pre-specified known signals in only six studies. Moreover, the personal perception of patients reported in social media could be used to implement effective risk communication strategies. However, signal detection in social media cannot be currently recommended for routine pharmacovigilance, due to logistic and technical issues.
Topics: Adverse Drug Reaction Reporting Systems; Data Mining; Databases, Factual; Drug-Related Side Effects and Adverse Reactions; Humans; Pharmacovigilance; Social Media
PubMed: 30285501
DOI: 10.1080/14740338.2018.1531847 -
Frontiers in Pediatrics 2023Acquired aplastic anemia (AAA) in pediatric patients is a rare disorder characterized by hypocellular bone marrow and pancytopenia. Eltrombopag, an oral thrombopoietin... (Review)
Review
BACKGROUND
Acquired aplastic anemia (AAA) in pediatric patients is a rare disorder characterized by hypocellular bone marrow and pancytopenia. Eltrombopag, an oral thrombopoietin receptor agonist, provides a hematologic improvement in adults with severe aplastic anemia (SAA) refractory to immunosuppressive therapy (IST). The association of ELT and IST was approved by the US Food and Drug Administration (FDA) for adults and children ≥2 years of age as a first-line treatment for SAA. However, the effects of ELT on pediatric patients with SAA remain controversial and limited.
METHODS AND FINDINGS
We conducted a systematic review of the most recent literature from Pubmed, Web of Science, and Embase, published up to 20th December 2022, in order to evaluate the available evidence on the efficacy and safety of ELT added to IST for the treatment of SAA in the pediatric population.
CONCLUSION
Eltrombopag added to the IST has shown a good safety profile, without manifestations of excessive toxic effects, although not all the results obtained from our studies support the addition of ELT to the IST in the first-line treatment of children with SAA.
SYSTEMATIC REVIEW REGISTRATION
https://www.crd.york.ac.uk/prospero/, identifier: CRD42022325859.
PubMed: 37168802
DOI: 10.3389/fped.2023.1149718 -
Expert Review of Clinical Pharmacology Nov 2022Interstitial lung disease (ILD) events associated with anti-human epidermal growth factor receptor 2 (HER2) antibody-drug conjugates (ADCs) have aroused wide attention. (Meta-Analysis)
Meta-Analysis
BACKGROUND
Interstitial lung disease (ILD) events associated with anti-human epidermal growth factor receptor 2 (HER2) antibody-drug conjugates (ADCs) have aroused wide attention.
RESEARCH DESIGN AND METHODS
In meta-analysis, we systematically reviewed literatures, and the outcomes were the proportion and risk of ILD related to anti-HER2 ADCs. A disproportionality analysis based on data from VigiBase was conducted to characterize the main features of anti-HER2 ADC-related ILD/pneumonitis.
RESULTS
Two hundred and forty-five all-grade and 47 grade ≥ 3 ILD events with the proportion of 4.4% (95% confidence interval (CI) [2.0%, 6.8%]) and 0.5% (95% CI [0.3%, 0.8%]) were observed for anti-HER2 ADCs, respectively. Trastuzumab emtansine, trastuzumab deruxtecan and trastuzumab duocarmazine significantly increased the risk of all-grade and grade ≥ 3 ILD events with Peto odd ratios of 2.62 (95% CI [1.71, 4.04], P < 0.0001) and 2.82 (95% CI [1.07, 7.42], P = 0.04), respectively. In VigiBase, 271 cases of ILD/pneumonitis related to trastuzumab emtansine and trastuzumab deruxtecan were extracted. The median time to the onset of event was 86 days and 54.95% of events occurred within 3 months.
CONCLUSIONS
Trastuzumab emtansine, trastuzumab deruxtecan and trastuzumab duocarmazine increased the risk of ILD, which can lead to serious outcomes and tends to occur early.
Topics: Humans; Female; Ado-Trastuzumab Emtansine; Pharmacovigilance; Trastuzumab; Receptor, ErbB-2; Immunoconjugates; Antineoplastic Agents; Lung Diseases, Interstitial; World Health Organization; Breast Neoplasms
PubMed: 36111954
DOI: 10.1080/17512433.2022.2121705 -
Current Medical Research and Opinion Jan 2022Globally, pharmacovigilance (PV) is crucial for the patient's safety and proper use of drugs. Spontaneous reporting of adverse drug reaction (ADR) is a professional...
BACKGROUND
Globally, pharmacovigilance (PV) is crucial for the patient's safety and proper use of drugs. Spontaneous reporting of adverse drug reaction (ADR) is a professional obligation of every healthcare professionals (HCPs). The purpose of this systematic review was to analyze the existing literature about the knowledge, attitude, and practices (KAP) level of HCPs regarding PV and ADRs reporting in Turkey.
METHODS
A systematic and comprehensive articles search strategy was carried out in different seven electronic databases (PubMed, PubMed Central, Goggle Scholar, Ovid-SP, MEDLINE, Wiley Online Library, DergiPark) from 2010 to 2020. We searched to identify existing literature about cross-sectional observational studies investigating the KAP of HCPs regarding PV and ADRs reporting in different geographical regions of Turkey. Quality assessment and risk of bias were assessed among included studies.
RESULTS
Fifteen studies were chosen for full-text analysis. Finally, according to inclusion criteria, seven research articles were selected for systematic review. Overall, the KAP of HCPs varies across the studies. The lack of a standardized validated measuring tool to evaluate the KAP and differences in questionnaire items were the main limitations in included studies. Around, 69.1% (range: 54.6-100%) of HCPs were not aware of the national pharmacovigilance center in Turkey. About, 37.5% (range: 7.1-75.7%) of HCPs believed that reporting of ADRs is not important and 87.5% (range: 69.3-100%) stated that they never reported ADR previously during their practice. The most frequently highlighted barriers to PV were lack of time, uncertainty and did not know where to report.
CONCLUSION
This systematic review revealed a major KAP gap in Turkey towards PV activities. Low ADR reporting practice of HCPs was a major identified issue. The creation of a mandatory unified PV education intervention for future HCPs to rationally report ADR of drugs are crucial for a better healthcare system.
Topics: Adverse Drug Reaction Reporting Systems; Cross-Sectional Studies; Drug-Related Side Effects and Adverse Reactions; Health Knowledge, Attitudes, Practice; Humans; Pharmacovigilance; Turkey
PubMed: 34694167
DOI: 10.1080/03007995.2021.1997287