31 new pubmed citations were retrieved for your search. Click on the search hyperlink below to display the complete search results:

("drug-induced" OR "drug-related") AND ("adverse events" OR "side effects" OR "side-effects")

These pubmed results were generated on 2020/07/01

PubMed comprises more than millions of citations for biomedical literature from MEDLINE, life science journals, and online books. Citations may include links to full-text content from PubMed Central and publisher web sites.

31 new pubmed citations were retrieved for your search. Click on the search hyperlink below to display the complete search results:

("drug-induced" OR "drug-related") AND ("adverse events" OR "side effects" OR "side-effects")

These pubmed results were generated on 2020/07/01

PubMed comprises more than millions of citations for biomedical literature from MEDLINE, life science journals, and online books. Citations may include links to full-text content from PubMed Central and publisher web sites.

Effects of postoperative medical treatment and expectant treatment on dysmenorrhea after conservative laparoscopic surgery for deep-infiltrating endometriosis accompanied by dysmenorrhea.

J Int Med Res. 2020 Jun;48(6):300060520931666

Authors: Zhu Q, Ma J, Zhao X, Liang G, Zhai J, Zhang J

Abstract
OBJECTIVE: To compare the efficacy of postoperative adjuvant treatment (gonadotropin-releasing hormone agonists [GnRHas] and oral contraceptives [OCs]) and expectant treatment in preventing recurrent dysmenorrhea following conservative laparoscopic surgery for deep infiltrating endometriosis (DIE) with dysmenorrhea.
METHODS: A prospective cohort study was conducted in Shanghai, China. In total, 147 patients with dysmenorrhea who underwent conservative laparoscopic surgery for DIE were enrolled. Following surgery, patients received either postoperative adjuvant therapy (GnRHa or OCs) for 6 months or expectant treatment according to a shared medical decision-making approach. The primary outcome was the postoperative recurrence of dysmenorrhea. The secondary outcomes included reproductive outcomes and drug-induced side effects.
RESULTS: The generalized estimating equation analysis illustrated that the visual analog scale for dysmenorrhea was significantly higher in the adjuvant treatment group than in the expectant treatment group. Kaplan-Meier analysis and the log-rank test demonstrated that the cumulative recurrence rate was higher in the expectant treatment group than in the adjuvant treatment group, but no difference was noted between the two hormonal treatments. Similar cumulative 24-month clinical pregnancy rates were observed among the three groups.
CONCLUSIONS: Compared with expectant management, postoperative medical treatment more effectively relieved symptoms and prevented the recurrence of dysmenorrhea.

PMID: 32586151 [PubMed - in process]

Administration and Dosing of Systemic Antifungal Agents in Pediatric Patients.

Paediatr Drugs. 2020 Apr;22(2):165-188

Authors: Downes KJ, Fisher BT, Zane NR

Abstract
Neonates and immunosuppressed/immunocompromised pediatric patients are at high risk of invasive fungal diseases. Appropriate antifungal selection and optimized dosing are imperative to the successful prevention and treatment of these life-threatening infections. Conventional amphotericin B was the mainstay of antifungal therapy for many decades, but dose-limiting nephrotoxicity and infusion-related adverse events impeded its use. Despite the development of several new antifungal classes and agents in the past 20 years, and their now routine use in at-risk pediatric populations, data to guide the optimal dosing of antifungals in children are limited. This paper reviews the spectra of activity for approved antifungal agents and summarizes the current literature specific to pediatric patients regarding pharmacokinetic/pharmacodynamic data, dosing, and therapeutic drug monitoring.

PMID: 31974859 [PubMed - indexed for MEDLINE]

Risks and management of antiepileptic drug induced skin reactions in the adult out-patient setting.

Seizure. 2019 Nov;72:61-70

Authors: Fowler T, Bansal AS, Lozsádi D

Abstract
Adverse cutaneous reactions caused by mostly aromatic antiepileptic drugs (AED) affect 50.000 people a year in the United Kingdom (UK; incidence 75.7/100.000). Optimal management of these cases is often difficult, as the patient may report symptoms to a general practitioner, attend Accident & Emergency or inform a specialist over the telephone or via email. When clinical assessment is limited it is thought safest to withdraw offending medication and inform the patient of a new drug allergy. This may unjustifiably restrict future treatment choices, and increase cost. Most frequent offenders are aromatic AEDs: carbamazepine, oxcarbazepine, eslicarbazepine, phenytoin, lamotrigine, phenobarbitone, primidone (recently licensed lacosamide associated with lower risk) and the sulpha-derivative zonisamide. Our study provides a summary of severe delayed allergic reactions and offers a pragmatic management pathway for patients suffering a suspected drug-induced rash. We include UK pretreatment screening guidelines, step by step clinical assessment of rash and associated symptoms aiding early identification of patients at risk of developing severe allergic reactions. At the same time our manuscript reviews published data informing best choice and titration of alternative medication when allergy confirmed. Finally we summarize current knowledge on genetic predisposition and other personalized risks of AED allergies identifying gaps in our current understanding.

PMID: 31708349 [PubMed - indexed for MEDLINE]

Sarecycline Review.

Ann Pharmacother. 2020 02;54(2):164-170

Authors: Haidari W, Bruinsma R, Cardenas-de la Garza JA, Feldman SR

Abstract
Objective: Sarecycline is a new oral tetracycline antibiotic recently approved by the US Food and Drug Administration. The aim of this article was to evaluate the data from published clinical trials of sarecycline in the treatment of acne, review the drug's pharmacology, and understand how this new medication may apply to clinical practice. Data Sources: A systematic literature review was performed using the terms sarecycline (Seysara), P005672, and WC-3035 in the MEDLINE and EMBASE databases. ClinicalTrials.gov was searched to identify ongoing or nonpublished studies. Study Selection and Data Extraction: Articles in English between January 2000 and April 2019 relating to clinical trials, pharmacology, safety, and microbiological profile were evaluated. Data Synthesis: In a phase 3 clinical trial (SC1401), absolute change from baseline in facial inflammatory lesion count at week 12 was -15.3 for the sarecycline arm and -10.1 for placebo (P < 0.01). In another phase 3 clinical trial (SC1402), the absolute change in this category was -15.7 for sarecycline and -10.7 for placebo (P < 0.01). Mean percentage change in facial inflammatory lesion count was higher in the sarecycline group than in the placebo group in both studies (P < 0.01). Relevance to Patient Care and Clinical Practice: The 1.5-mg/kg sarecycline dose has efficacy in reducing inflammatory lesions, is well tolerated, and has more targeted antimicrobial activity, which may help reduce the risk of developing antibiotic resistance. Conclusions: This novel, once-daily treatment may represent a useful treatment for patients with moderate to severe acne.

PMID: 31462063 [PubMed - indexed for MEDLINE]

Descriptive study of adverse drug reactions in a tertiary care pediatric hospital in México from 2014 to 2017.

PLoS One. 2020;15(3):e0230576

Authors: Morales-Ríos O, Cicero-Oneto C, García-Ruiz C, Villanueva-García D, Hernández-Hernández M, Olivar-López V, Jiménez-Juárez RN, Jasso-Gutiérrez L

Abstract
INTRODUCTION: In Pediatrics, adverse drug reactions (ADRs) affect morbidity and mortality. In Mexico, the characteristics of ADRs and suspect drugs have not been described in hospitalized children.
OBJECTIVE: To estimate the frequency of ADRs and describe them, as well as suspect drugs, in a tertiary care pediatric hospital in Mexico.
METHODS: A total of 1,649 Hospital Infantil de Mexico Federico Gómez ADR reports were analyzed. Completeness of the information was assessed, and ADRs severity and seriousness were assigned based on NOM-220-SSA1-2012, with causality being established according to the Naranjo algorithm. ADRs were classified with WHO Adverse Drug Reaction Terminology (WHO-ART). The drugs involved in ADRs were categorized according to the Anatomical Therapeutic Chemical (ATC) classification. Descriptive analysis was performed using the SPSS 20 statistical package.
RESULTS: Of all the reports, 5.8% lacked sufficient information for the analysis (grade 0). ADRs frequency ranged from 2.12% to 8.07%. ADRs occurred most commonly in children (56.9%), in the female gender (52%), in subjects with normal BMI Z-score (46.6%) and malnutrition (35.3%), diagnosed with neoplasms (72.2%) and in the Emergency Department (70.0%). ADRs were severe in 14.4% of cases, in 81.0% they were serious and 2.1% were classified as definite. Most common serious ADR was febrile neutropenia (44.5%). The 0.7% of patients recovering with sequelae; 1.1% died (with the medication being associated) and 70.3% were admitted to the hospital as a result of an ADR. Antineoplastic and immunomodulating agents were more commonly associated with serious ADRs.
CONCLUSION: ADRs affected morbidity and mortality, which is why strengthening pharmacovigilance programs in Mexican pediatric hospitals is necessary.

PMID: 32208451 [PubMed - indexed for MEDLINE]

Toxic Acetaminophen Exposure Induces Distal Lung ER Stress, Proinflammatory Signaling, and Emphysematous Changes in the Adult Murine Lung.

Oxid Med Cell Longev. 2019;2019:7595126

Authors: Sandoval J, Orlicky DJ, Allawzi A, Butler B, Ju C, Phan CT, Toston R, De Dios R, Nguyen L, McKenna S, Nozik-Grayck E, Wright CJ

Abstract
Clinical studies have demonstrated a strong association between both acute toxic exposure and the repetitive, chronic exposure to acetaminophen (APAP) with pulmonary dysfunction. However, the mechanisms underlying this association are unknown. Preclinical reports have demonstrated that significant bronchiolar injury occurs with toxic APAP exposure, but very little information exists on how the distal lung is affected. However, cells in the alveolar space, including the pulmonary epithelium and resident macrophages, express the APAP-metabolizing enzyme CYP2E1 and are a potential source of toxic metabolites and subsequent distal lung injury. Thus, we hypothesized that distal lung injury would occur in a murine model of toxic APAP exposure. Following exposure of APAP (280 mg/kg, IP), adult male mice were found to have significant proximal lung histopathology as well as distal lung inflammation and emphysematous changes. Toxic APAP exposure was associated with increased CYP2E1 expression in the distal lung and accumulation of APAP-protein adducts. This injury was associated with distal lung activation of oxidant stress, endoplasmic reticulum stress, and inflammatory stress response pathways. Our findings confirm that following toxic APAP exposure, distal lung CYP2E1 expression is associated with APAP metabolism, tissue injury, and oxidant, inflammatory, and endoplasmic reticulum signaling. This previously unrecognized injury may help improve our understanding of the relationship between APAP and pulmonary-related morbidity.

PMID: 31885815 [PubMed - indexed for MEDLINE]

Pharmacist-Physician Organic Cooperation Is an Effective Strategy to Reduce the Medication-related Problems, An Experience in CKD Patients.

Iran J Kidney Dis. 2019 11;13(6):419-420

Authors: Esamily H, Adl F, Saffaei A, Ziaie S

PMID: 31880590 [PubMed - indexed for MEDLINE]

Adverse Events Due to Insomnia Drugs Reported in a Regulatory Database and Online Patient Reviews: Comparative Study.

J Med Internet Res. 2019 11 08;21(11):e13371

Authors: Borchert JS, Wang B, Ramzanali M, Stein AB, Malaiyandi LM, Dineley KE

Abstract
BACKGROUND: Patient online drug reviews are a resource for other patients seeking information about the practical benefits and drawbacks of drug therapies. Patient reviews may also serve as a source of postmarketing safety data that are more user-friendly than regulatory databases. However, the reliability of online reviews has been questioned, because they do not undergo professional review and lack means of verification.
OBJECTIVE: We evaluated online reviews of hypnotic medications, because they are commonly used and their therapeutic efficacy is particularly amenable to patient self-evaluation. Our primary objective was to compare the types and frequencies of adverse events reported to the Food and Drug Administration Adverse Event Reporting System (FAERS) with analogous information in patient reviews on the consumer health website Drugs.com. The secondary objectives were to describe patient reports of efficacy and adverse events and assess the influence of medication cost, effectiveness, and adverse events on user ratings of hypnotic medications.
METHODS: Patient ratings and narratives were retrieved from 1407 reviews on Drugs.com between February 2007 and March 2018 for eszopiclone, ramelteon, suvorexant, zaleplon, and zolpidem. Reviews were coded to preferred terms in the Medical Dictionary for Regulatory Activities. These reviews were compared to 5916 cases in the FAERS database from January 2015 to September 2017.
RESULTS: Similar adverse events were reported to both Drugs.com and FAERS. Both resources identified a lack of efficacy as a common complaint for all five drugs. Both resources revealed that amnesia commonly occurs with eszopiclone, zaleplon, and zolpidem, while nightmares commonly occur with suvorexant. Compared to FAERS, online reviews of zolpidem reported a much higher frequency of amnesia and partial sleep activities. User ratings were highest for zolpidem and lowest for suvorexant. Statistical analyses showed that patient ratings are influenced by considerations of efficacy and adverse events, while drug cost is unimportant.
CONCLUSIONS: For hypnotic medications, online patient reviews and FAERS emphasized similar adverse events. Online reviewers rated drugs based on perception of efficacy and adverse events. We conclude that online patient reviews of hypnotics are a valid source that can supplement traditional adverse event reporting systems.

PMID: 31702558 [PubMed - indexed for MEDLINE]

Improving the Gastrointestinal Tolerability of Fumaric Acid Esters: Early Findings on Gastrointestinal Events with Diroximel Fumarate in Patients with Relapsing-Remitting Multiple Sclerosis from the Phase 3, Open-Label EVOLVE-MS-1 Study.

Adv Ther. 2019 11;36(11):3154-3165

Authors: Palte MJ, Wehr A, Tawa M, Perkin K, Leigh-Pemberton R, Hanna J, Miller C, Penner N

Abstract
INTRODUCTION: Diroximel fumarate (DRF) is a novel oral fumarate in development for patients with relapsing forms of multiple sclerosis (MS). Clinical findings from the DRF development program suggest that rates of gastrointestinal (GI) treatment-emergent adverse events (TEAEs) and discontinuation due to GI TEAEs are low, based on clinical and real-world observations of other fumaric acid esters, including dimethyl fumarate (DMF). The incidence of GI TEAEs varies from 40 to 88% in clinical and real-world studies of DMF. The objective of this study is to present GI tolerability findings from the EVOLVE-MS-1 study and present biologic hypotheses for the improved GI properties of DRF.
METHODS: GI TEAEs and treatment discontinuation because of GI TEAEs were assessed in DRF-treated patients with relapsing-remitting MS who were participating in the ongoing, 96-week, open-label, phase 3 EVOLVE-MS-1 study.
RESULTS: As of March 30, 2018, a total of 696 patients were enrolled in EVOLVE-MS-1. GI TEAEs were reported in 30.9% (215/696) of patients; the vast majority (96%; 207/215) experienced events that were mild or moderate in severity. When GI AEs did occur, they occurred early in treatment, resolved (88.8%; 191/215), and were of short duration [median 7.5 (range 1-87) days] in most patients. GI TEAEs led to < 1% of patients discontinuing treatment.
CONCLUSIONS: We suggest that the distinct chemical structure of DRF contributes to the observed low rates of GI TEAEs and GI-associated treatment discontinuations, possibly due to a combination of several factors. We hypothesize that these factors may include less reactivity with off-target proteins and/or lower production of a methanol leaving group that may contribute to GI irritation. A direct comparison of GI tolerability with DRF versus DMF is being evaluated in the EVOLVE-MS-2 study.
TRIAL REGISTRATION: ClinicalTrials.gov number NCT02634307.
FUNDING: Alkermes Inc. (Waltham, MA, USA) and Biogen (Cambridge, MA, USA).

PMID: 31538304 [PubMed - indexed for MEDLINE]

Issues, challenges, and the way forward in conducting clinical trials among neonates: investigators' perspective.

J Perinatol. 2019 09;39(Suppl 1):20-30

Authors: Sivanandan S, Jain K, Plakkal N, Bahl M, Sahoo T, Mukherjee S, Gupta YK, Agarwal R

Abstract
Clinical trials are essential to test the safety and efficacy of new treatments in any population. The paucity of drug trials especially in the neonatal population has led to the widespread use of unlicensed or off-label medications, exposing them to the risks of drug toxicity and ineffective treatment. Ethical and operational challenges are no longer considered valid excuses for not conducting drug trials in neonates. We recently participated in a combined phase-2 and phase-3 trial investigating a new indigenous goat lung surfactant extract (GLSE) for the treatment of respiratory distress syndrome (RDS) in preterm neonates. In this article, we share pertinent challenges faced by us during the trial to better inform and foster-positive discussion among drug developers, administrators, regulatory authorities, patient advocacy groups, and researchers. Also, we provide many tools developed for the GLSE trial that can be modified and used by prospective trialists.

PMID: 31485015 [PubMed - indexed for MEDLINE]

Predictors of motor complications in early Parkinson's disease: A prospective cohort study.

Mov Disord. 2019 08;34(8):1174-1183

Authors: Kelly MJ, Lawton MA, Baig F, Ruffmann C, Barber TR, Lo C, Klein JC, Ben-Shlomo Y, Hu MT

Abstract
OBJECTIVE: The objective of this study was to identify clinical predictors of motor complications (dyskinesia and motor fluctuations) of levodopa in a prospectively recruited PD cohort using longitudinal analysis.
METHODS: An inception cohort (Oxford Discovery) of 734 patients was followed to a maximum of 10 years from diagnosis using a discrete-time survival analysis. A subset analysis was used to validate an online dyskinesia-risk calculator developed from the results of the Stalevo Reduction in Dyskinesia Evaluation PD trial.
RESULTS: A total of 186 cases of dyskinesia and 254 cases of motor fluctuations were observed. Dyskinesia incidence increased with time (risk per 100 participants [95% confidence interval] 13 [11-16] <3.5 years, 16 [13-21] 3.5-5.0 years, 19 [14-26] 5-6.5 years, and 23 [16-33] >6.5 years from diagnosis). Motor complication predictors were grouped as medication predictors, disease predictors and patient predictors. Baseline nonmotor feature severity, low mood, anxiety, and age at symptom onset were associated with motor complications among a number of previously identified predictors. Replication of the Stalevo Reduction in Dyskinesia Evaluation PD calculator was reasonable with the area under the curve for dyskinesia risk score as a predictor of dyskinesia being 0.68 (95% confidence interval, 0.55-0.81).
CONCLUSIONS: This study quantifies risk of motor complications, finds consistent predictors, and demonstrates the novel finding that nonmotor features of PD, particularly low mood and anxiety, are significant risk factors for motor complications. Further validation of dyskinesia risk scores are required as well as evidence to determine if the routine use of such scores can be clinically valuable in enhancing patient care and quality of life. © 2019 The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society.

PMID: 31283854 [PubMed - indexed for MEDLINE]

Enzyme replacement therapy outcomes across the disease spectrum: Findings from the mucopolysaccharidosis VI Clinical Surveillance Program.

J Inherit Metab Dis. 2019 05;42(3):519-526

Authors: Harmatz PR, Lampe C, Parini R, Sharma R, Teles EL, Johnson J, Sivam D, Sisic Z

Abstract
The impact of galsulfase enzyme replacement therapy in patients with mucopolysaccharidosis (MPS) VI with phenotypes at either end of the disease spectrum was evaluated. The MPS VI Clinical Surveillance Program (CSP) was established to collect long-term observational data from routine clinical and laboratory assessments. A subanalysis of the CSP was performed in patients with pretreatment urinary glycosaminoglycan (uGAG) levels <100 μg/mg and ≥200 μg/mg creatinine (low- and high-uGAG) who had received galsulfase for ≥6 months. uGAG, 6-minute walk test (6MWT), 3-minute stair climb test (3MSCT), pulmonary function measures, height/growth, cardiac function, and safety were evaluated. Patients with a high-uGAG level at pre-treatment baseline (N = 68) showed greater impairments in endurance and pulmonary function than those with low-baseline uGAG levels (N = 39). From pre-treatment baseline, the distance walked on the 6MWT in the low- and high-uGAG groups increased by a mean (±SD) of 49 (±151) meters and 42 (±165) meters (median follow-up 5.5 and 7.7 years), respectively. The number of stairs/min climbed in the 3MSCT in the low- and high-uGAG groups increased by a mean of 18 (±33) and 30 (±45) (median follow-up 2.8 and 3.5 years), respectively. Overall, pulmonary function remained unchanged for both groups. No impact was seen on cardiac function. Galsulfase was generally well tolerated in both groups, with most adverse events being MPS-related complications unrelated to galsulfase. Results of this CSP sub-analysis suggest that galsulfase stabilizes MPS VI in the long-term and has an acceptable safety profile, regardless of baseline disease severity.

PMID: 30834539 [PubMed - indexed for MEDLINE]

Informed Consent: A Policy Prescription for Communicating Benefit and Risk in State Medical Marijuana Programs.

Psychiatr Serv. 2020 Jun 24;:appips202000140

Authors: Messamore E, Dugan SE

Abstract
In creating medical marijuana laws, state governments signal to the public that marijuana can safely and effectively treat a wide range of diseases. In many cases, these state approvals overestimate the benefits of marijuana and understate the risks. After a comprehensive review of the medical literature, the National Academies of Sciences, Engineering, and Medicine identified six medical benefits from marijuana that were supported with at least a moderate level of medical evidence and 14 potential health hazards. In contrast, the average state medical marijuana program lists 18 medical benefits, and 24 state medical marijuana program websites say nothing about possible risks. Medication approval processes through the federal government traditionally require independent analysis of data from well-designed clinical trials that measure the effectiveness and capture the risks of adverse effects from specific doses of the medicine. These considerations are generally missing from state approvals of medical marijuana. The power to declare something to be a legitimate medicine comes with the responsibility to provide information that people need to use the medicine wisely. The authors recommend that states that declare marijuana to be a medicine should inform the public about the quality of medical evidence behind each approved use and publicize all scientifically credible risks.

PMID: 32576122 [PubMed - as supplied by publisher]

Clozapine-related drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome: a systematic review.

Expert Rev Clin Pharmacol. 2020 Jun 24;:

Authors: de Filippis R, Soldevila-Matías P, De Fazio P, Guinart D, Fuentes-Durá I, Rubio JM, Kane JM, Schoretsanitis G

Abstract
INTRODUCTION: The Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome is a severe, multiorganic and potentially life-threatening drug-induced hypersensitivity reaction, linked to several common drugs, including antiepileptics, antibiotics and several psychotropic drugs, including clozapine. Due to the importance of clozapine in the management of treatment-resistant schizophrenia, a systematic review and characterization of clozapine-related DRESS syndrome is long overdue.
AREAS COVERED: This systematic review was conducted following PRISMA guidelines. PubMed, Embase, PsychINFO and the Cochrane Library databases were independently reviewed up to November 1st, 2019 for articles reporting clozapine-related DRESS syndrome cases. The RegiSCAR score system was applied to systematically characterize the clinical presentations of selected studies.
EXPERT OPINION: Clozapine-related DRESS syndrome was reported in six patients from four articles. Five patients received polypharmacy. Skin rash and liver involvement with elevated liver enzymes were very common. No fatal cases were found. Treatment mainly included clozapine discontinuation and immunosuppression. The mismatch between incidences of DRESS with other responsible drugs, the common misdiagnosis of this syndrome, and the fact that an extensive literature search only identified 6 cases suggests that clozapine-related DRESS may be overlooked. It is, therefore, necessary to optimize diagnostic strategies to identify immune-related side effects of clozapine.

PMID: 32576056 [PubMed - as supplied by publisher]

Comparing drug safety of hepatitis C therapies using post-market data.

BMC Med Inform Decis Mak. 2019 08 08;19(Suppl 4):147

Authors: Huang J, Zhang X, Tong J, Du J, Duan R, Yang L, Moore JH, Tao C, Chen Y

Abstract
BACKGROUND: Hepatitis C affects about 3 % of the world's population. In the United States, about 3.5 million have chronic hepatitis C, and it is the leading cause of liver cancer and the most common indication for liver transplantation. In the last decades, new advances in therapy have substantially increased the cure rate of hepatitis C to more than 95% with the use of antiviral agents. However, drug safety of the new treatments remains one of the major concerns. Data from the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) and the Electronic Health Record (EHR) systems provide crucial post-market information to evaluate drug safety. Currently, quantitative evidence of drug safety of hepatitis C treatments based on post-market data are still limited, and there is also a lack of a standard statistical procedure to systematically compare drug safety across multiple drugs using FAERS and EHR.
METHOD: In this study, we presented a statistical procedure to compare the difference in adverse events (AE) across multiple hepatitis C drugs using data from FAERS and EHR, and to assess the consistency of results from two data bases. Through three major steps, including descriptive comparison, testing for difference among groups, and quantification of association, the proposed method can provide a quantitative comparison on safety of multiple drugs. Specifically, we compared drugs that were approved by FDA to treat hepatitis C before 2011versus those approved after 2013. We used spontaneous AE reports submitted between 2004 to 2015 from FAERS data base and medical records between 1999 to 2015 from the Cerner health facts data base to estimate and compare the rate of AE after drug use.
RESULT: We studied 30 most frequently reported AEs after treatment of hepatitis C, comparing the difference between drugs approved before 2011versus those approved after 2013. Our results showed that there was difference in rate of AE between the two groups of treatment. We reported the AEs that have significant statistical difference, and estimate the difference attributable to variation of age and gender between the two groups of drug users. Our findings are consistent with results in existing literature. Moreover, we compared the results obtained from FAERS data and EHR data, and evaluated the consistency of evidence.
CONCLUSION: The proposed procedure is a general and standardized pipeline that can be used to compare and visualize drug safety among multiple drugs to support regulatory decision-makings using post-market data. We showed that there was statistically significant difference in AE rates between the new and old therapies for hepatitis C. We showed that both FAERS and EHR contained large information for research of post-market drug safety, but each has its own strength and limitations. Cautions should be taken when combining evidence from the two data resources and there is a need of more sophisticated informatics and statistical tools for evidence synthesis.

PMID: 31391106 [PubMed - indexed for MEDLINE]

Topical moxifloxacin-induced toxic epidermal necrolysis and Stevens-Johnson syndrome.

J Postgrad Med. 2019 Apr-Jun;65(2):125-126

Authors: Dhavaleshwar A, Nayak V, Hande M, Pai R

PMID: 31036782 [PubMed - indexed for MEDLINE]

11 new pubmed citations were retrieved for your search. Click on the search hyperlink below to display the complete search results:

("drug-induced" OR "drug-related") AND ("adverse events" OR "side effects" OR "side-effects")

These pubmed results were generated on 2020/06/24

PubMed comprises more than millions of citations for biomedical literature from MEDLINE, life science journals, and online books. Citations may include links to full-text content from PubMed Central and publisher web sites.

11 new pubmed citations were retrieved for your search. Click on the search hyperlink below to display the complete search results:

("drug-induced" OR "drug-related") AND ("adverse events" OR "side effects" OR "side-effects")

These pubmed results were generated on 2020/06/24

PubMed comprises more than millions of citations for biomedical literature from MEDLINE, life science journals, and online books. Citations may include links to full-text content from PubMed Central and publisher web sites.