Update on vaccination of preterm infants: a systematic review about safety and efficacy/effectiveness. Proposal for a position statement by Italian Society of Pediatric Allergology and Immunology jointly with the Italian Society of Neonatology.

Expert Rev Vaccines. 2019 05;18(5):523-545

Authors: Chiappini E, Petrolini C, Sandini E, Licari A, Pugni L, Mosca FA, Marseglia GL

Abstract
INTRODUCTION: Preterm infants (PIs) are at increased risk of vaccine-preventable diseases (VPDs). However, delayed vaccination start and low vaccine coverage are still reported. Areas covered: This systematic review includes 37 articles on preterm vaccination published in 2008-2018 in PubMed. Both live attenuated and inactivated vaccines are safe and well tolerated in PIs. Local reactions, apnea, and reactivity changes are the most frequently reported adverse events. Lower gestational age and birth weight, preimmunization apnea, longer use of continuous positive airway pressure (CPAP) are risk factors for apnea. The proportion of PIs who develop protective humoral and cellular immunity is generally similar to full terms although later gestational age is associated with increased antibody IgG concentrations (i.e. against certain pneumococcal serotypes, influenza, hepatitis B virus and poliovirus 1) and increased mononuclear cells proliferation (i.e. after inactivated poliovirus). Expert opinion: PIs can be safely and adequately protected by available vaccines with the same schedule used for full terms. Data at this regard have been retrieved by studies using a 3-dose primary series for pneumococcal and hexavalent vaccines. Further studies are needed regarding the 2 + 1 schedule. Apnea represents a nonspecific stress response in PIs, thus those hospitalized at 2 months should have cardio-respiratory monitoring after their first vaccination.

PMID: 30952198 [PubMed - indexed for MEDLINE]

14 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 2020/06/10

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.

14 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 2020/06/10

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.

15 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 2020/06/09

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.

14 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 2020/06/09

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.

Molecular basis of mood and cognitive adverse events elucidated via a combination of pharmacovigilance data mining and functional enrichment analysis.

Arch Toxicol. 2020 Jun 05;:

Authors: Andronis C, Silva JP, Lekka E, Virvilis V, Carmo H, Bampali K, Ernst M, Hu Y, Loryan I, Richard J, Carvalho F, Savić MM

Abstract
Drug-induced Mood- and Cognition-related adverse events (MCAEs) are often only detected during the clinical trial phases of drug development, or even after marketing, thus posing a major safety concern and a challenge for both pharmaceutical companies and clinicians. To fill some gaps in the understanding and elucidate potential biological mechanisms of action frequently associated with MCAEs, we present a unique workflow linking observational population data with the available knowledge at molecular, cellular, and psychopharmacology levels. It is based on statistical analysis of pharmacovigilance reports and subsequent signaling pathway analyses, followed by evidence-based expert manual curation of the outcomes. Our analysis: (a) ranked pharmaceuticals with high occurrence of such adverse events (AEs), based on disproportionality analysis of the FDA Adverse Event Reporting System (FAERS) database, and (b) identified 120 associated genes and common pathway nodes possibly underlying MCAEs. Nearly two-thirds of the identified genes were related to immune modulation, which supports the critical involvement of immune cells and their responses in the regulation of the central nervous system function. This finding also means that pharmaceuticals with a negligible central nervous system exposure may induce MCAEs through dysregulation of the peripheral immune system. Knowledge gained through this workflow unravels putative hallmark biological targets and mediators of drug-induced mood and cognitive disorders that need to be further assessed and validated in experimental models. Thereafter, they can be used to substantially improve in silico/in vitro/in vivo tools for predicting these adversities at a preclinical stage.

PMID: 32504122 [PubMed - as supplied by publisher]

Adenosine A2A receptor agonist (regadenoson) in human lung transplantation.

J Heart Lung Transplant. 2020 Jun;39(6):563-570

Authors: Lau CL, Beller JP, Boys JA, Zhao Y, Phillips J, Cosner M, Conaway MR, Petroni G, Charles EJ, Mehaffey JH, Mannem HC, Kron IL, Krupnick AS, Linden J

Abstract
BACKGROUND: Currently, there are no clinically approved treatments for ischemia-reperfusion injury after lung transplantation. Pre-clinical animal models have demonstrated a promising efficacy of adenosine 2A receptor (A2AR) agonists as a treatment option for reducing ischemia-reperfusion injury. The purpose of this human study, is to conduct a Phase I clinical trial for evaluating the safety of continuous infusion of an A2AR agonist in lung transplant recipients.
METHODS: An adaptive, two-stage continual reassessment trial was designed to evaluate the safety of regadenoson (A2AR agonist) in the setting of lung transplantation. Continuous infusion of regadenoson was administered to lung transplant recipients that was started at the time of skin incision. Adverse events and dose-limiting toxicities, as pre-determined by a study team and assessed by a clinical team and an independent safety monitor, were the primary end-points for safety in this trial.
RESULTS: Between January 2018 and March 2019, 14 recipients were enrolled in the trial. Of these, 10 received the maximum infused dose of 1.44 µg/kg/min for 12 hours. No dose-limiting toxicities were observed. The steady-state plasma regadenoson levels sampled before the reperfusion of the first lung were 0.98 ± 0.46 ng/ml. There were no mortalities within 30 days.
CONCLUSIONS: Regadenoson, an A2AR agonist, can be safely infused in the setting of lung transplantation with no dose-limiting toxicities or drug-related mortality. Although not powered for the evaluation of secondary end-points, the results of this trial and the outcome of pre-clinical studies warrant further investigation with a Phase II randomized controlled trial.

PMID: 32503727 [PubMed - as supplied by publisher]

Famotidine use and quantitative symptom tracking for COVID-19 in non-hospitalised patients: a case series.

Gut. 2020 Jun 04;:

Authors: Janowitz T, Gablenz E, Pattinson D, Wang TC, Conigliaro J, Tracey K, Tuveson D

Abstract
OBJECTIVE: Treatment options for non-hospitalised patients with coronavirus disease 2019 (COVID-19) to reduce morbidity, mortality and spread of the disease are an urgent global need. The over-the-counter histamine-2 receptor antagonist famotidine is a putative therapy for COVID-19. We quantitively assessed longitudinal changes in patient reported outcome measures in non-hospitalised patients with COVID-19 who self-administered high-dose famotidine orally.
DESIGN: Patients were enrolled consecutively after signing written informed consent. Data on demographics, COVID-19 diagnosis, famotidine use, drug-related side effects, temperature measurements, oxygen saturations and symptom scores were obtained using questionnaires and telephone interviews. Based on a National Institute of Health (NIH)-endorsed Protocol to research Patient Experience of COVID-19, we collected longitudinal severity scores of five symptoms (cough, shortness of breath, fatigue, headaches and anosmia) and general unwellness on a four-point ordinal scale modelled on performance status scoring. All data are reported at the patient level. Longitudinal combined normalised symptom scores were statistically compared.
RESULTS: Ten consecutive patients with COVID-19 who self-administered high-dose oral famotidine were identified. The most frequently used famotidine regimen was 80 mg three times daily (n=6) for a median of 11 days (range: 5-21 days). Famotidine was well tolerated. All patients reported marked improvements of disease related symptoms after starting famotidine. The combined symptom score improved significantly within 24 hours of starting famotidine and peripheral oxygen saturation (n=2) and device recorded activity (n=1) increased.
CONCLUSIONS: The results of this case series suggest that high-dose oral famotidine is well tolerated and associated with improved patient-reported outcomes in non-hospitalised patients with COVID-19.

PMID: 32499303 [PubMed - as supplied by publisher]

Evaluating FMX-101 as a promising therapeutic for the treatment of acne.

Expert Opin Pharmacother. 2020 May;21(7):741-746

Authors: Valente Duarte de Sousa IC

Abstract
INTRODUCTION: Oral minocycline is a mainstay of therapy for moderate-to-severe acne; however, systemic side effects which include hepatotoxicity, lupus-like syndrome, drug hypersensitivity syndrome, autoimmune hepatitis, polyarteritis nodosa, gastrointestinal side effects and skin hyperpigmentation are of concern. Topical antibiotics commonly used in acne, such as erythromycin and clindamycin, present high P. acnes resistance rates which has opened the market for new topical antibiotics. FMX-101 is a novel topical minocycline foam that has shown promising results in phase I, II and III trials for the treatment of moderate-to-severe acne with a better safety profile than oral minocycline.
AREAS COVERED: The author provides an overview FMX-101 including its clinical efficacy and safety. The author then provides their expert opinion on this treatment and its potential for the treatment option for acne.
EXPERT OPINION: The topical foam formulation of FMX-101 has been shown to reduce both inflammatory and non-inflammatory lesions and to improve IGA scores in patients with moderate-to-severe acne without significant systemic absorption thus limiting associated side effects. Overall, the proven efficacy and safety profile of FMX-101, together with the low systemic absorption, high skin tolerability and cosmetically acceptable foam formulations render this novel therapy an important addition to the acne treatment armamentarium.

PMID: 32037906 [PubMed - indexed for MEDLINE]

Concerns Raised by a Study of Suicide as an Adverse Drug Effect-Replicating Findings From Real-World Data.

JAMA Netw Open. 2019 10 02;2(10):e1913284

Authors: Katz IR

PMID: 31617919 [PubMed - indexed for MEDLINE]

Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (RADIANCE): a multicentre, randomised, 24-month, phase 3 trial.

Lancet Neurol. 2019 11;18(11):1021-1033

Authors: Cohen JA, Comi G, Selmaj KW, Bar-Or A, Arnold DL, Steinman L, Hartung HP, Montalban X, Kubala Havrdová E, Cree BAC, Sheffield JK, Minton N, Raghupathi K, Huang V, Kappos L, RADIANCE Trial Investigators

Abstract
BACKGROUND: Ozanimod is a sphingosine 1-phosphate receptor modulator, which selectively binds to sphingosine 1-phosphate receptor subtypes 1 and 5 with high affinity. In the RADIANCE phase 2 study in participants with relapsing multiple sclerosis, ozanimod was associated with better efficacy than placebo on MRI measures and was well tolerated. The RADIANCE phase 3 study aimed to confirm the safety and efficacy of ozanimod versus interferon beta-1a in individuals with relapsing multiple sclerosis.
METHODS: We did a 24-month, multicentre, double-blind, double-dummy phase 3 trial in participants with relapsing multiple sclerosis at 147 medical centres and clinical practices in 21 countries. Participants were aged 18-55 years, had multiple sclerosis according to 2010 McDonald criteria, a relapsing clinical course, brain MRI lesions consistent with multiple sclerosis, an expanded disability status scale score of 0·0-5·0, and either at least one relapse within 12 months before screening or at least one relapse within 24 months before screening plus at least one gadolinium-enhancing lesion within the 12 months before randomisation. Participants were randomly assigned (1:1:1) via an interactive voice response system to daily oral ozanimod 1·0 mg or 0·5 mg or weekly intramuscular interferon beta-1a 30 μg. Participants, investigators, and study staff were masked to treatment allocation. The primary endpoint was annualised relapse rate (ARR) over 24 months. The primary analysis was done in the intention-to-treat population of all participants who received study drug and safety was assessed in all randomly assigned participants who received study drug, grouped by highest dose of ozanimod received. This trial is registered at ClinicalTrials.gov, NCT02047734, and EudraCT, 2012-002714-40.
FINDINGS: Between Dec 27, 2013, and March 31, 2015, we screened 1695 participants, of which 375 did not meet inclusion criteria. 1320 participants were enrolled and randomly assigned to a group, of whom 1313 received study drug (433 assigned to ozanimod 1·0 mg, 439 assigned to ozanimod 0·5 mg, and 441 assigned to interferon beta-1a) and 1138 (86·7%) completed 24 months of treatment. Adjusted ARRs were 0·17 (95% CI 0·14-0·21) with ozanimod 1·0 mg, 0·22 (0·18-0·26) with ozanimod 0·5 mg, and 0·28 (0·23-0·32) with interferon beta-1a, with rate ratios versus interferon beta-1a of 0·62 (95% CI 0·51-0·77; p<0·0001) for ozanimod 1·0 mg and 0·79 (0·65 to 0·96; p=0·0167) for ozanimod 0·5 mg. The incidence of treatment-emergent adverse events was higher in the interferon beta-1a group (365 [83·0%] of 440 participants) than in the ozanimod 1·0 mg group (324 [74·7%] of 434) or the ozanimod 0·5 mg group (326 [74·3%] of 439). More participants in the interferon beta-1a group had treatment-emergent adverse events leading to treatment discontinuation than in the ozanimod groups. Incidences of infections and serious treatment-emergent adverse events were similar across treatment groups. No cases of ozanimod-related symptomatic reduction in heart rate and no second-degree or third-degree cases of atrioventricular block were reported.
INTERPRETATION: In this 24-month phase 3 study in participants with relapsing multiple sclerosis, ozanimod was well tolerated and associated with a significantly lower rate of clinical relapses than intramuscular interferon beta-1a. These findings show the potential of ozanimod as an effective oral therapy for individuals with relapsing multiple sclerosis.
FUNDING: Celgene International II.

PMID: 31492652 [PubMed - indexed for MEDLINE]

Refined common terminology criteria for adverse events criteria - respective systemic melanoma therapy.

Melanoma Res. 2019 08;29(4):444-445

Authors: Kohlmann J, Kirsten H, Simon JC, Ziemer M

PMID: 31246725 [PubMed - indexed for MEDLINE]

How hospital pharmacists prioritise patients at high-risk for medication harm.

Res Social Adm Pharm. 2019 10;15(10):1266-1273

Authors: Falconer N, Barras M, Cottrell N

Abstract
BACKGROUND: Medication harm is experienced by up to 30% of hospitalised patients, of which 7% experience severe harm. Pharmacist review can mitigate this harm. However, in increasingly busy hospitals, with high patient throughput, and scarce resources, there is a need to prioritise patients. Current methods are cumbersome, include many risk factors and are not evaluated in the clinical setting.
OBJECTIVES: To determine key criteria used by hospital pharmacists and investigate perspectives related to patient prioritisation for potential medication harm in the hospital setting.
METHODS: This study used two methods; focus groups and a cross-sectional survey of Australian hospital pharmacists. Focus groups were used to identify criteria and perspectives related to prioritisation and were analysed thematically. Criteria from focus groups, and a systematic review, were used to design the survey. The survey was distributed via the Society of Hospital Pharmacists of Australia. The top 10 prioritisation criteria, and associated sub-criteria selected by over 50% of respondents were ranked. Combination of criteria used most frequently on a day-to-day basis were identified.
RESULTS: Twenty clinical pharmacists participated in four, one-hour, audio recorded focus groups. Using inductive thematic analysis of transcripts three themes were identified; 1) prioritisation criteria, 2) barriers to, and 3) facilitators of patient prioritisation, with five sub-themes and 26 codes. Pharmacists identified a number of barriers such as a lack of relevant handover information. Organisational demands, such as patient discharge and medications supply also influenced priority and could act as barriers to a pharmacist enacting their prioritisation plan. A total of 231 pharmacists completed the survey. High priority criteria included, renal impairment, use of high-risk medications and therapeutic drug monitoring.
CONCLUSION: Pharmacists described prioritisation as a multifactorial process with a focus on high-risk medications and renal impairment. These findings will inform the development of a predictive risk score for patient prioritisation.

PMID: 30466812 [PubMed - indexed for MEDLINE]

The use of goal attainment scaling during clinical medication review in older persons with polypharmacy.

Res Social Adm Pharm. 2019 10;15(10):1259-1265

Authors: Verdoorn S, Blom J, Vogelzang T, Kwint HF, Gussekloo J, Bouvy ML

Abstract
BACKGROUND: Studies have shown that a clinical medication review (CMR) reduces drug-related problems (DRPs), but the effects on clinical outcomes are less clear. Perhaps, CMRs in older persons could me more effective when they focus on patients' personal goals and health-related complaints.
OBJECTIVE: The aim of this study was to investigate whether goal attainment scaling (GAS) is a useful tool for determining goals and monitoring their attainment during CMR.
METHODS: This study was an analysis based on data of the intervention group of the DREAMeR-study; a randomised controlled trial investigating the effects of CMR in primary care. 315 persons aged ≥70 years using ≥7 drugs were randomised to the intervention: a CMR focused on personal goals using GAS. Outcome measures were: percentage of persons with health-related goals, attainment of goals measured with GAS-scores after three and six months, type of health-related goals and implementation rates of recommendations for GAS-related DRPs and other DRPs.
RESULTS: A total of 406 health-related goals were set for 283 of 315 included persons (90%). Of the 350 evaluated goals (86%), 37% was attained after three months and 43% after six months. The goals 'reduce pain' (n = 66, 16%), 'improve mobility' (n = 57, 14%) and 'reduce number of pills' (n = 37, 9.1%) were most prevalent. The implementation rate of recommendations for GAS-related DRPs was 81% compared to 62% for not GAS-related DRPs (p < 0.05).
CONCLUSION: Goal setting is important for prioritizing the most important problems during clinical medication review and Goal Attainment Scaling seems to be a useful tool for monitoring the attainment of these goals.

PMID: 30425008 [PubMed - indexed for MEDLINE]

Effect of Treprostinil on the Early Postoperative Prognosis of Patients with Severe Left Heart Valvular Disease Combined with Severe Pulmonary Hypertension.

Ann Thorac Cardiovasc Surg. 2020 Jun 03;:

Authors: Huang ST, Xu N, Sun KP, Chen Q, Cao H

Abstract
OBJECTIVE: To investigate the effect of treprostinil on the early postoperative prognosis of patients with severe left heart valvular disease combined with severe pulmonary hypertension (PAH).
METHODS: A retrospective study including 55 patients with severe left heart valvular disease combined with severe PAH who underwent left heart valve replacement in our hospital between January 2019 and May 2019 was conducted. Patients were divided into two groups (treprostinil group and control group), and the clinical data of patients in the two groups were compared and analyzed.
RESULTS: Compared with the preoperative status, the mean postoperative pulmonary artery pressure (mPAP) in both groups was significantly lower. Compared with the control group, the treprostinil group had a significantly lower mPAP. Moreover, the postoperative mechanical ventilation time, intensive care unit (ICU) stay, and hospital stay of the treprostinil group were significantly shorter than those of the control group. There were no serious drug-related side effects in either group.
CONCLUSIONS: Treprostinil can improve the early postoperative prognosis of patients with severe left heart valvular disease combined with severe PAH undergoing prosthetic valve replacement.

PMID: 32493870 [PubMed - as supplied by publisher]

Short-term results of upper airway stimulation in obstructive sleep apnoea patients: the Amsterdam experience.

J Laryngol Otol. 2020 Jun 03;:1-6

Authors: Vonk PE, Ravesloot MJL, van Maanen JP, de Vries N

Abstract
OBJECTIVES: This paper aimed to: retrospectively analyse single-centre results in terms of surgical success, respiratory outcomes and adverse events after short-term follow up in obstructive sleep apnoea patients treated with upper airway stimulation; and evaluate the correlation between pre-operative drug-induced sleep endoscopy findings and surgical success.
METHODS: A retrospective descriptive cohort study was conducted, including a consecutive series of obstructive sleep apnoea patients undergoing implantation of an upper airway stimulation system.
RESULTS: Forty-four patients were included. The total median Apnoea-Hypopnea Index and oxygen desaturation index significantly decreased from 37.6 to 8.3 events per hour (p < 0.001) and from 37.1 to 15.9 events per hour (p < 0.001), respectively. The surgical success rate was 88.6 per cent, and did not significantly differ between patients with or without complete collapse at the retropalatal level (p = 0.784). The most common therapy-related adverse event reported was (temporary) stimulation-related discomfort.
CONCLUSION: Upper airway stimulation is an effective and safe treatment in obstructive sleep apnoea patients with continuous positive airway pressure intolerance or failure. There was no significant difference in surgical outcome between patients with tongue base collapse with or without complete anteroposterior collapse at the level of the palate.

PMID: 32493527 [PubMed - as supplied by publisher]

Herbal medication triggering lupus nephritis - a case report.

BMC Complement Med Ther. 2020 Jun 02;20(1):163

Authors: Abdul Rashid AM, Abd Ghani F, Inche Mat LN, Lim CTS

Abstract
BACKGROUND: Herbal medication is widely used in our region as a mode of alternative medicine. Its contents and combinations are often modified to suit the needs of different populations. These products are said to boost the immune system and may serve as a protective measure against many diseases including Systemic Lupus Erythematosus (SLE). Some even lay claims to be able to cure SLE. Although they are not without side effects, these medications are still preferred due to their widespread availability and affordability, compared to modern medications. However, to date, there have been no reported cases in which these traditional medications can trigger a lupus-like reaction, moreover one involving the kidneys.
CASE PRESENTATION: We report a patient who developed overt lupus nephritis after consuming a course of herbal supplement. Her renal status did not improve upon cessation of the offending drug, and she required immunosuppressive therapy. After one cycle of IV cyclophosphamide, we managed to get the patient into remission - she is now on tapering doses of steroids.
CONCLUSION: We wish to highlight the possibility of consumption of herbal medication and the emergence of drug-induced lupus nephritis. A thorough anamnesis and high index of suspicion of drug-induced lupus nephritis is warranted when a patient on supplements presents with urinary abnormalities.

PMID: 32487242 [PubMed - in process]

Drug-Related Cutaneous Adverse Events in Philadelphia Chromosome-Negative Myeloproliferative Neoplasms: A Literature Review.

Int J Mol Sci. 2020 May 30;21(11):

Authors: Malato A, Rossi E, Palumbo GA, Guglielmelli P, Pugliese N

Abstract
Since myeloproliferative neoplasms (MPN) pose a significant risk for vascular and thrombotic complications, cytoreductive therapies, such as hydroxyurea (HU), interferon (IFN) inhibitors, and Janus kinase (JAK) inhibitors are recommended for patients at high risk. However, these agents also place patients at increased risk for drug-related cutaneous adverse events. Herein, we review the literature on skin toxicity related to the use of drugs for the treatment of MPN. Overall, the cytoreductive agents used for MPN are generally well tolerated and considered to be safe, except IFN, for which dropout rates as high as 25% have been reported. While IFN is known to give rise to flu syndrome, it rarely leads to hematological alterations. The most common hematological side effects of HU are mild and include granulocytopenia, anemia, and thrombocytopenia. The JAK inhibitor ruxolitinib has been associated with cytopenia and a higher incidence of viral infections, as well as increased risk for basal cell carcinoma (BCC) and squamous cell carcinoma (SCC). Based on the present analysis, it can be concluded that cutaneous toxicity is not a negligible complication of commonly used treatments for MPN. While further research is needed, patients on these agents, and especially those with a history of cutaneous malignancies, should undergo thorough skin examination before and during therapy. In addition, detailed history is critical since many patients who develop non-melanoma skin cancer have multiple preexisting risk factors for cutaneous carcinogenesis.

PMID: 32486130 [PubMed - in process]

[Establishment of a rapid identification of adverse drug reaction program in R language implementation based on monitoring data].

Zhejiang Da Xue Xue Bao Yi Xue Ban. 2020 May 25;49(2):253-259

Authors: Hong D, Ni J, Shan W, Li L, Hu X, Yang H, Zhao Q, Zhang X

Abstract
OBJECTIVE: To establish a clinically applicable model of rapid identification of adverse drug reaction program (RiADP) for risk management and decision-making of clinical drug use.
METHODS: Based on the theory of disproportion analysis, frequency method and Bayes method, a clinically applicable RiADP model in R language background was established, and the parameters of the model were interpreted by MedDRA coding. Based on the actual monitoring data of FDA, the model was validated by the assessing hepatotoxicity of lopinavir/ritonavir (LPV/r).
RESULTS: The established RiADP model included four parameters: standard value of adverse drug reaction signal information, empirical Bayesian geometric mean value, ratio of reporting ratio and number of adverse drug reaction cases. Through the application of R language parameter package "phViD", the model parameters could be output quickly. After being encoded by MedDRA, it was converted into clinical terms to form a clinical interpretation report of adverse drug reactions. In addition, the evaluation results of LPV/r hepatotoxicity by the model were matched with the results reported in latest literature, which also proved the reliability of the model results.
CONCLUSIONS: In this study, a rapid identification method of adverse reactions based on post marketing drug monitoring data was established in R language environment, which is capable of sending rapid warning of adverse reactions of target drugs in public health emergencies, and providing intuitive evidence for risk management and decision-making of clinical drugs.

PMID: 32391674 [PubMed - indexed for MEDLINE]

Bleeding erosions in a man with psoriasis.

Postgrad Med J. 2020 Jan;96(1131):53-54

Authors: Bhatia R, Hazarika N, Chandrasekaran D, Joshi P

PMID: 31326941 [PubMed - indexed for MEDLINE]