scholarly journals Pregnancy Outcomes of Patients Exposed to Adalimumab in Japan

2018 ◽  
Vol 37 (2) ◽  
pp. 123-130 ◽  
Author(s):  
Yumi Kawai ◽  
Tsuyoshi Tsuchiya ◽  
Shigeru Aoki
Keyword(s):  
Adverse Events ◽  
Pregnancy Outcomes ◽  
Outcome Data ◽  
Full Term ◽  
Third Trimester ◽  
Serious Adverse Events ◽  
Additional Risk ◽  
Safety Database ◽  
Induced Abortions ◽  
Adalimumab Treatment

Background: This is the first retrospective report of pregnancy outcomes after exposure to adalimumab treatment in Japan. Methods: Using the AbbVie safety database, we analyzed pregnancy outcome data from patients who received adalimumab treatment from April 16, 2008, to May 15, 2017. Results: Data were extracted retrospectively for 74 pregnancies in 73 patients. More than half of the patients included in the study received adalimumab for the treatment of Crohn’s disease (37.8%) or ulcerative colitis (20.3%), while 9.5% received adalimumab for rheumatoid arthritis. Of the 53 pregnancies with available outcome data, 45 newborns (45/53 [84.9%]) were delivered. Of these births, 30 were full-term, 2 were preterm, and 13 were unknown. Apgar scores were available for 11 of the 16 newborns whose mothers were exposed to adalimumab in the third trimester; all scores were within the normal range. Low birth weight was observed in 5 infants out of the 30 full-term deliveries. There were also 5 miscarriages (5/53 [9.4%]), 2 induced abortions (2/53 [3.8%]), and 1 stillbirth (1/53 [1.9%]). Eight maternal adverse events were observed in 5 pregnancies; no serious adverse events occurred. Conclusion: Although safety concerns were inconclusive, these data do not report additional risk to pregnancy outcomes with adalimumab exposure.

scholarly journals Pregnancy Outcomes in Subjects Exposed to Certolizumab Pegol

2015 ◽  
Vol 42 (12) ◽  
pp. 2270-2278 ◽  
Author(s):  
Megan E.B. Clowse ◽  
Douglas C. Wolf ◽  
Frauke Förger ◽  
John J. Cush ◽  
Amanda Golembesky ◽  
...  
Keyword(s):  
Pregnancy Outcomes ◽  
Additional Data ◽  
Certolizumab Pegol ◽  
Harmful Effect ◽  
First Trimester ◽  
Safety Database ◽  
Live Births ◽  
Induced Abortions ◽  
Concomitant Medications ◽  
Almost All

Objective.To provide information on pregnancy outcomes in women receiving certolizumab pegol (CZP).Methods.The UCB Pharma safety database was searched for pregnancies through to September 1, 2014. Reports for maternal and paternal CZP exposure were included and outcomes examined, and data on CZP exposure, pregnancy, comorbidities, and infant events were extracted by 2 independent reviewers. Concomitant medications and disease activity were reviewed for clinical trial patients.Results.Of 625 reported pregnancies, 372 (59.5%) had known outcomes. Paternal exposure pregnancies (n = 33) reported 27 live births, 4 miscarriages, 1 induced abortion, and 1 stillbirth. Maternal exposure pregnancies (n = 339) reported 254 live births, 52 miscarriages, 32 induced abortions, and 1 stillbirth. Almost all reported pregnancies had exposure to CZP in the first trimester, when organogenesis takes place, and a third of them continued the drug into the second and/or third trimesters. The most frequent indications for maternal CZP use were Crohn disease (192/339) and rheumatic diseases (118/339). Twelve cases of congenital malformation and a single neonatal death were reported.Conclusion.Analysis of pregnancy outcomes after exposure to CZP supports previous reports, suggesting a lack of harmful effect of maternal CZP exposure on pregnancy outcomes. However, additional data from a larger number of outcomes after exposure and studies including an unexposed comparison group are required to fully evaluate CZP safety and tolerability in pregnancy.

scholarly journals Reversal of SARS-CoV2 Induced Hypoxia by Nebulized Sodium-Ibuprofen in a Compassionate Use Program

2021 ◽  
Author(s):  
Oscar Salva ◽  
Pablo Alexis Doreski ◽  
Celia Sara Giler ◽  
Dario Conrado Quinodoz ◽  
Lucia Guadalupe Guzman ◽  
...  
Keyword(s):  
Adverse Events ◽  
Average Length ◽  
Vital Signs ◽  
Standard Of Care ◽  
Ambient Air ◽  
Outcome Data ◽  
Compassionate Use ◽  
Rapid Improvement ◽  
Serious Adverse Events ◽  
Average Length Of Stay

Abstract BackgroundSodium-ibuprofenate in hypertonic saline (NaIHS) administered directly to the lungs by nebulization and inhalation has antibacterial and anti-inflammatory effects with the potential to deliver these benefits to hypoxic patients. We describe a compassionate use program that offered this therapy to hospitalized COVID-19 patients.MethodsNaIHS (50 mg ibuprofen, tid) was provided in addition to standard of care to hospitalized Covid-19 patients until oxygen saturation levels of >94% were achieved on ambient air. Patients wore a containment hood to diminish aerosolization. Outcome data from participating patients treated at multiple hospitals in Argentina between April 04, 2020, through October 31, 2020 are summarized.Results383 patients were treated, including 327 not on mechanical ventilation at baseline (MV) and 56 ICU patients receiving MV. For those not on baseline MV (59±0.8 years), 64% were male, most with at least one recognized risk factor for disease severity, and mean NEWS2 score prior to treatment initiation of 7.0±0.1. The average length of stay (ALOS) was 11.5±0.3 days and length of treatment (LOT) 9.0±0.2 days. In patients on baseline MV (60.6±2.2 years), 69.9% were male, baseline mean NEWS2 Score was 8.8±0.4, ALOS 15.5±1.4 days and LOT 10.5±0.7 days. Reversal of deterioration in oxygenation and NEWS2 scores was observed acutely following initiation of therapy. Overall in-hospital mortality was 10.7% among patients not on MV at baseline, and 19.6% among patients receiving MV at baseline. No serious adverse events were considered related to ibuprofen therapy.ConclusionsTreatment of COVID-19 pneumonitis with inhalational nebulized NaIHS was associated with rapid improvement in hypoxia and vital signs, with no serious adverse events attributed to therapy. Nebulized NaIHS is worthy of further study in randomized, placebo-controlled trials.(ClinicalTrials.gov:NCT04382768).

scholarly journals Pregnancy Outcomes in Patients Treated with Bosutinib

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 1729-1729 ◽  
Author(s):  
Jorge E. Cortes ◽  
Carlo Gambacorti-Passerini ◽  
Michael W. Deininger ◽  
Elisabetta Abruzzese ◽  
Liza DeAnnuntis ◽  
...  
Keyword(s):  
Spontaneous Abortion ◽  
Pregnancy Outcomes ◽  
Research Funding ◽  
First Trimester ◽  
Maternal Exposure ◽  
Safety Database ◽  
Spontaneous Reports ◽  
Dilation And Curettage ◽  
Vaginal Deliveries ◽  
Induced Abortions

Abstract Introduction: Studies in animals have shown reproductive toxicity with bosutinib exposure, with teratogenic events in maternal exposure, but little is known about its effect during conception or pregnancy in humans. Methods: Here we describe pregnancy outcomes in bosutinib-treated patients from the Pfizer safety database, which includes cases from both clinical trials and spontaneous reports. Pregnancy cases reported up to February 28, 2018 were identified by searching the database using the Standardized MedDRA Query Pregnancy and Neonatal Topics in patients receiving bosutinib. Results: The database search identified 33 relevant pregnancy reports, including 17 cases of exposure via the father and 16 cases of maternal exposure. Among the 16 cases of maternal exposure, 5 vaginal deliveries of healthy babies, 2 patient-requested induced abortions, 1 spontaneous abortion, and 1 partial molar pregnancy requiring a dilation and curettage were reported. In 1 case, the patient was reported to have delivered a baby, but the details of the status of the baby was not provided. Outcomes in 6 cases are unknown. Of the healthy deliveries, 4 pregnancies went to full term (≥39 weeks) and 1 was of unknown duration; bosutinib was discontinued during the first trimester of pregnancy in all 5 cases. The reported spontaneous abortion was due to a suspected ectopic pregnancy in a 34-year-old patient who began taking bosutinib 500 mg once daily while pregnant and was thought to be unrelated to bosutinib exposure. Of the 17 cases of exposure via father, 8 vaginal deliveries of healthy babies, 1 Caesarean section delivery of a healthy baby, 4 induced abortions, and 1 spontaneous abortion were reported. The remaining 3 cases had unknown outcomes. Of the 4 induced abortions, 1 was elective due to an unintended pregnancy, and 2 were due to unknown reasons. In the last case, it was reported that the fetus was not growing properly and that the pregnancy would subsequently be terminated; no confirmation of congenital abnormality or further information is available. The reported spontaneous abortion was thought to be unrelated to bosutinib; fetal biopsy revealed basal deciduitis with necrosis loci and bleeding. Conclusions: Overall, a review of the available experience with bosutinib in pregnancy did not identify any safety signals. However, adverse effects of bosutinib exposure at conception or during pregnancy in humans cannot be ruled out, particularly if therapy is not interrupted upon recognition of pregnancy. Bosutinib is not recommended for use during pregnancy, and patients on bosutinib treatment should use effective contraception. Disclosures Cortes: Astellas Pharma: Consultancy, Research Funding; Novartis: Consultancy, Research Funding; Daiichi Sankyo: Consultancy, Research Funding; Pfizer: Consultancy, Research Funding; Arog: Research Funding. Gambacorti-Passerini:BMS: Consultancy; Pfizer: Consultancy, Honoraria, Research Funding. Deininger:Pfizer: Consultancy, Membership on an entity's Board of Directors or advisory committees; Blueprint: Consultancy. Abruzzese:Novartis: Consultancy; Ariad: Consultancy; BMS: Consultancy; Pfizer: Consultancy. DeAnnuntis:Pfizer Inc: Employment, Equity Ownership. Brümmendorf:Janssen: Consultancy; Merck: Consultancy; Novartis: Consultancy, Research Funding; Pfizer: Consultancy, Research Funding; Takeda: Consultancy.

scholarly journals Safety of Influenza A H1N1pdm09 Vaccines: An Overview of Systematic Reviews

2021 ◽  
Vol 12 ◽  
Author(s):  
Lene Kristine Juvet ◽  
Anna Hayman Robertson ◽  
Ida Laake ◽  
Siri Mjaaland ◽  
Lill Trogstad
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Systematic Reviews ◽  
Pregnancy Outcomes ◽  
Influenza A ◽  
Demyelinating Diseases ◽  
Short Term ◽  
Serious Adverse Events ◽  
Increased Risk ◽  
Influenza A H1n1

BackgroundIn 2009, a new influenza A H1N1 virus emerged causing a global pandemic. A range of monovalent influenza A H1N1pdm09 vaccines with or without adjuvants were developed. After the mass vaccination campaigns safety concerns related to H1N1pdm09 vaccines were reported. More than a decade later, reported AEFIs are still under scrutiny. We performed a systematic review aiming to synthesize the evidence on the safety of the H1N1pdm09 vaccines on reported outcomes from existing systematic reviews.MethodsFour electronic databases, PubMed, EMBASE, Epistimonikos and the Cochrane Database of Systematic Reviews were searched for articles on H1N1pdm09 vaccination published from 2009 to January 2021. Systematic reviews assessing short- or long-term adverse events after H1N1pdm09 vaccination were considered for inclusion. Data was extracted from all selected reviews. Outcomes were grouped and results from each included review were presented narratively and in tables.Results16 systematic reviews met the inclusion criteria. Reported outcomes were short-term events (3 reviews), fetal/pregnancy outcomes (8 reviews), Guillain-Barré syndrome (GBS) (4 reviews), narcolepsy (2 reviews) demyelinating diseases (1 review based on one study only) and inflammatory bowel disease (IBD) (1 review). Short-term serious adverse events were rare, 3 cases amongst 16725 subjects in 18 randomized controlled trials (0.018%). No deaths were reported. The risks of local events were generally higher for adjuvanted vaccines as compared to unadjuvanted vaccines. Maternal H1N1pdm09 vaccination in any trimester was not associated with an increase in preterm birth, small for gestational age, congenital malformations or fetal death. For GBS, results were conflicting. The main systematic review on narcolepsy found a 5-14-fold increased risk in children, and a 2-7- fold increased risk in adults after vaccination with Pandemrix. The attributable risk of narcolepsy one year after vaccination was 1 case per 18 400 vaccine doses in children/adolescents, and 1 case per 181 000 vaccine doses in adults.ConclusionAdjuvanted vaccines had more local but not serious adverse events compared to unadjuvanted vaccines. Vaccination with Pandemrix was strongly associated with narcolepsy, particularly in children. No increased risks of pregnancy outcomes were seen after pandemic vaccination. The findings on GBS were inconclusive.

Safety and Optimal Timing of BCG Vaccination in Infants Born to Mothers Receiving Anti-TNF Therapy for Inflammatory Bowel Disease

2020 ◽  
Vol 14 (12) ◽  
pp. 1780-1784 ◽  
Author(s):  
Sang Hyoung Park ◽  
Hyo Jong Kim ◽  
Chang Kyun Lee ◽  
Eun Mi Song ◽  
Sang-Bum Kang ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Adverse Events ◽  
Bowel Disease ◽  
Optimal Timing ◽  
Third Trimester ◽  
Serious Adverse Events ◽  
Bcg Vaccination ◽  
The Third ◽  
Gestational Week ◽  
Inflammatory Bowel

Abstract Backgrounds and Aims We aimed to evaluate the safety of Bacille Calmette–Guérin [BCG] vaccination in infants born to mothers receiving anti-tumour necrosis factor [anti-TNF] therapy for inflammatory bowel disease. Methods Adverse events of BCG vaccination were evaluated in 90 infants who were last exposed to anti-TNF agents at a median of gestational week 30. Results After receiving BCG vaccination at a median age of 6 months [range, 0.25–11 months], three infants [3.3%] showed injection site swelling, two of whom also showed axillar lymphadenopathy. The rates of adverse events were similar between infants who were last exposed to anti-TNF agents before the third trimester [n = 35] and those who were last exposed in the third trimester [n = 55] [2.9% vs 3.6%; p = 1.00]. All adverse events were spontaneously resolved and there were no serious adverse events such as active tuberculosis infection or death. Conclusions BCG vaccination after 6 months of age is of low risk in infants exposed to anti-TNF agents in utero.

PP16 Prehospital recognition and antibiotics for 999 patients with sepsis: feasibility study results

2019 ◽  
Vol 36 (10) ◽  
pp. e8.1-e8
Author(s):  
Jenna Bulger ◽  
Susan Allen ◽  
Jan Davies ◽  
Timothy Driscoll ◽  
Gemma Ellis ◽  
...  
Keyword(s):  
Adverse Events ◽  
Early Recognition ◽  
Randomised Trial ◽  
Intervention Group ◽  
Final Diagnosis ◽  
Outcome Data ◽  
Control Group ◽  
Serious Adverse Events ◽  
Study Results ◽  
The Mean

BackgroundSepsis is a common condition which kills approximately 44,000 people annually in the UK. Early recognition and management of sepsis has been shown to reduce mortality and improve outcomes. Paramedics frequently attend patients with sepsis, and are well placed to provide early diagnosis and treatment. We aimed to assess whether a multi-centre randomised trial to evaluate pre-hospital antibiotics was feasible.MethodsVolunteer paramedics used scratchcards to allocate patients with ‘Red Flag’ Sepsis at random between experimental and control arms. The primary outcome was mortality at six months. We also measured: adverse events, costs, final diagnosis, length of stay in hospital, and quality of care; and collected qualitative data about acceptability to patients in interviews, and paramedics in focus groups. We pre-specified criteria for deciding whether to progress to a fully powered trial based on: recruitment of paramedics and patients; retrieval of outcome data; safety; acceptability; and diagnostic accuracy.ResultsFifty-four paramedics completed their training and were issued scratchcards to randomly allocate patients to trial arms. Patients were recruited from 1.12.17 to 31.5.18. In total, 118 patients were randomly allocated to trial arms; four patients dissented to be included in the trial, leaving 114 patients to follow-up. Sixty-two patients (54%) were allocated to the intervention arm. The mean age of the control arm was 71.2 years (range 28–97); 33 (65%) control participants were female. In the intervention arm the mean age was 75.6 years (range 30–99) and 38 patients (61%) were female. Nine patients in the control group (18%) and 17 in the intervention group (28%) were already taking antibiotics at the time of their 999 call. Twenty-three questionnaires were received. No serious adverse events were reported.ConclusionsComplete results will be presented at the time of the conference, when routine linked anonymised outcomes are available.

scholarly journals Compassionate Use of REGEN-COV ® in Patients with COVID-19 and Immunodeficiency-Associated Antibody Disorders

2021 ◽  
Author(s):  
David Stein ◽  
Ernesto Oviedo-Orta ◽  
Wendy A Kampman ◽  
Jennifer McGinniss ◽  
George Betts ◽  
...  
Keyword(s):  
Adverse Events ◽  
Retrospective Analysis ◽  
Treatment Options ◽  
Clinical Status ◽  
Outcome Data ◽  
Compassionate Use ◽  
Rt Pcr ◽  
Serious Adverse Events ◽  
Oxygenation Status ◽  
Related Reaction

Abstract Background Patients with immunodeficiency-associated antibody disorders are at a higher risk of prolonged/persistent COVID-19 infection, having no viable treatment options. Methods A retrospective analysis of patients with primary and/or secondary immunodeficiency-associated antibody disorders who received casirivimab and imdevimab (REGEN-COV ®) under emergency compassionate use. Objectives describe safety and response to REGEN-COV, focusing on the subset of patients who had COVID-19 duration ≥21 days before treatment. Results Quantitative (change in oxygenation status and/or viral load) and/or qualitative (physician-reported clinical status) patient outcomes data are reported from 64 patients who received REGEN-COV. Improvement in ≥1 outcome was observed in 90.6% of the overall patient group. Thirty-seven of these had COVID-19 duration ≥21 days before treatment; median time from diagnosis to REGEN-COV was 60.5 days. Of the 29 patients with COVID-19 duration ≥21 days before treatment and available outcome data, 96.6% showed improvement in ≥1 outcome. In the 14 patients with post-treatment RT-PCR results available, 11 (78.6%) reported a negative RT-PCR following treatment, with 5 (45.5%) reporting a negative RT-PCR within 5 days and 8 (72.7%) within 21 days of treatment. Ten of 85 patients (11.8%) experienced serious adverse events, only one was an infusion-related reaction, possibly related to REGEN-COV. Two deaths were reported, neither were attributed to REGEN-COV. Conclusions In this retrospective analysis of immunodeficient patients granted REGEN-COV under the compassionate use program, REGEN-COV treatment was associated with rapid viral clearance and clinical improvement in patients with long-standing COVID-19. Adverse events were consistent with COVID-19 and its associated complications, and due to patients’ concurrent medical conditions.

scholarly journals Real-World Evidence for the Safety and Efficacy of CGRP Monoclonal Antibody Therapy Added to OnabotulinumtoxinA Treatment for Migraine Prevention in Adult Patients With Chronic Migraine

2022 ◽  
Vol 12 ◽  
Author(s):  
Laszlo Mechtler ◽  
Nicolas Saikali ◽  
Jennifer McVige ◽  
Olivia Hughes ◽  
Alexandra Traut ◽  
...  
Keyword(s):  
Adverse Events ◽  
Chronic Migraine ◽  
Combination Treatment ◽  
Real World ◽  
Insurance Coverage ◽  
Preventive Treatment ◽  
Outcome Data ◽  
Adult Patients ◽  
Real World Data ◽  
Serious Adverse Events

Background: OnabotulinumtoxinA and calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAbs) target different migraine pathways, therefore, combination treatment may provide additional effectiveness for the preventive treatment of chronic migraine (CM) than either treatment alone. The objective of this study was to collect real-world data to improve the understanding of the safety, tolerability, and effectiveness of adding a CGRP mAb to onabotulinumtoxinA treatment for the preventive treatment of CM.Methods: This was a retrospective, longitudinal study conducted using data extracted from a single clinical site's electronic medical records (EMR) of adult patients (≥18 years) with CM treated with ≥2 consecutive cycles of onabotulinumtoxinA before ≥1 month of continuous onabotulinumtoxinA and CGRP mAb (erenumab, fremanezumab, or galcanezumab) combination treatment. Safety was evaluated by the rate of adverse events (AE) and serious adverse events (SAE). The proportion of patients who discontinued either onabotulinumtoxinA, a CGRP mAb, or combination treatment, and the reason for discontinuation, if available, was collected. The effectiveness of combination preventive treatment was assessed by the reduction in monthly headache days (MHD). Outcome data were extracted from EMR at the first CGRP mAb prescription (index) and up to four assessments at ~3, 6, 9, and 12 months post-index. The final analyses were based on measures consistently reported in the EMR.Results: EMR were collected for 192 patients, of which 148 met eligibility criteria and were included for analysis. Erenumab was prescribed to 56.7% of patients, fremanezumab to 42.6%, and galcanezumab to 0.7%. Mean (standard deviation [SD]) MHD were 20.4 (6.6) prior to onabotulinumtoxinA treatment and 14.0 (6.9) prior to the addition of a CGRP mAb (baseline). After real-world addition of a CGRP mAb, there were significant reductions in MHD at the first assessment (~3 months) (mean −2.6 days/month, 95% CI −3.7, −1.4) and at all subsequent visits. After ~12 months of continuous combination treatment, MHD were reduced by 4.6 days/month (95% CI −6.7, −2.5) and 34.9% of patients achieved ≥50% MHD reduction from index. AEs were reported by 18 patients (12.2%), with the most common being constipation (n = 8, 5.4% [onabotulinumtoxinA plus erenumab only]) and injection site reactions (n = 5, 3.4%). No SAEs were reported. Overall, 90 patients (60.8%) discontinued one or both treatments. The most common reason for discontinuing either treatment was lack of insurance coverage (40%); few (~14%) patients discontinued a CGRP mAb and none discontinued onabotulinumtoxinA due to safety/tolerability.Conclusion: In this real-world study, onabotulinumtoxinA was effective at reducing MHD and the addition of a CGRP mAb was safe, well-tolerated and associated with incremental and clinically meaningful reductions in MHD for those who stayed on the combination treatment. No new safety signals were identified. Of those who discontinued, the majority reported lack of insurance coverage as a reason. Prospective real-world and controlled trials are needed to further evaluate the safety and potential benefits of this combination treatment paradigm for people with CM.

scholarly journals Microbial Preparations (Probiotics) for the Prevention of Clostridium difficile Infection in Adults and Children: An Individual Patient Data Meta-analysis of 6,851 Participants

2018 ◽  
Vol 39 (07) ◽  
pp. 771-781 ◽  
Author(s):  
Bradley C. Johnston ◽  
Lyubov Lytvyn ◽  
Calvin Ka-Fung Lo ◽  
Stephen J. Allen ◽  
Duolao Wang ◽  
...  
Keyword(s):  
Clostridium Difficile ◽  
Adverse Events ◽  
Meta Analysis ◽  
Grey Literature ◽  
Single Species ◽  
Outcome Data ◽  
Serious Adverse Events ◽  
Treatment Standard ◽  
Adults And Children ◽  
Adjusted Model

OBJECTIVETo determine whether probiotic prophylaxes reduce the odds ofClostridium difficileinfection (CDI) in adults and children.DESIGNIndividual participant data (IPD) meta-analysis of randomized controlled trials (RCTs), adjusting for risk factors.METHODSWe searched 6 databases and 11 grey literature sources from inception to April 2016. We identified 32 RCTs (n=8,713); among them, 18 RCTs provided IPD (n=6,851 participants) comparing probiotic prophylaxis to placebo or no treatment (standard care). One reviewer prepared the IPD, and 2 reviewers extracted data, rated study quality, and graded evidence quality.RESULTSProbiotics reduced CDI odds in the unadjusted model (n=6,645; odds ratio [OR] 0.37; 95% confidence interval [CI], 0.25–0.55) and the adjusted model (n=5,074; OR, 0.35; 95% CI, 0.23–0.55). Using 2 or more antibiotics increased the odds of CDI (OR, 2.20; 95% CI, 1.11–4.37), whereas age, sex, hospitalization status, and high-risk antibiotic exposure did not. Adjusted subgroup analyses suggested that, compared to no probiotics, multispecies probiotics were more beneficial than single-species probiotics, as was using probiotics in clinical settings where the CDI risk is ≥5%. Of 18 studies, 14 reported adverse events. In 11 of these 14 studies, the adverse events were retained in the adjusted model. Odds for serious adverse events were similar for both groups in the unadjusted analyses (n=4,990; OR, 1.06; 95% CI, 0.89–1.26) and adjusted analyses (n=4,718; OR, 1.06; 95% CI, 0.89–1.28). Missing outcome data for CDI ranged from 0% to 25.8%. Our analyses were robust to a sensitivity analysis for missingness.CONCLUSIONSModerate quality (ie, certainty) evidence suggests that probiotic prophylaxis may be a useful and safe CDI prevention strategy, particularly among participants taking 2 or more antibiotics and in hospital settings where the risk of CDI is ≥5%.TRIAL REGISTRATIONPROSPERO 2015 identifier: CRD42015015701Infect Control Hosp Epidemiol2018;771–781

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