A Retrospective Case Series Analysis of Pregnancy and COVID-19 Based on a Global Postmarketing COVID-19 Surveillance Program.

Purpose: To document and characterize COVID-19 cases involving pregnancy in the context of exposure to pharmaceutical products.

Methods: This retrospective case series analysis leveraged the Pfizer safety database containing worldwide adverse event data related to use of Pfizer products between October 1, 2019 and November 3, 2022. Selected Medical Dictionary for Drug Regulatory Activities (Version 25.

Reporting of COVID-19 Reinfection and Potential Role of Immunosuppressant/Immunomodulating Agents: A Cross-Sectional Observational Analysis Based on a Spontaneous Reporting Database.

Background: The enduring presence of COVID-19 and subsequent increasing incidence of COVID-19 reinfection has prompted evaluation of associated risk factors, particularly the role of immunosuppression.

Objective: The objective of this study was to characterize cases indicative of COVID-19 reinfection with respect to their reported use of immunosuppressant/immunomodulating agents.

Methods: This cross-sectional observational study leveraged the Pfizer global safety database (SDB) containing adverse event data collected in association with use of Pfizer products between 1 October 2019, and 30 June 2022.

Effects of the COVID-19 Pandemic on Pharmacovigilance Strategy, Systems, and Processes of Large, Medium, and Small Companies: An Industry Survey.

Purpose: The COVID-19 pandemic poses an unprecedented threat to global business relationships and dynamics. The pharmacovigilance function of pharmaceutical companies is particularly susceptible to changing external pressures because of its highly structured compliance activities. We conducted an industry-wide survey to provide insights on how the pharmacovigilance function responded to the challenges posed by the pandemic.

Global Safety Database Summary of COVID-19-Related Drug Utilization-Safety Surveillance: A Sponsor's Perspective.

Introduction: Evidence-based clinical data on coronavirus disease 2019 (COVID-19) pharmacotherapies are scarce.

Objective: This study documented and characterized COVID-19 cases reported in individuals receiving treatment with Pfizer pharmaceutical products and cases that reported use of Pfizer pharmaceutical products for COVID-19 treatment.

Methods: This retrospective observational review leveraged the Pfizer safety database containing adverse event data collected in association with use of Pfizer products between 1 October, 2019, and 25 June, 2020; the database includes worldwide adverse event data from various sources.

Correction to: Adverse Drug Reaction Case Safety Practices in Large Biopharmaceutical Organizations from 2007 to 2017: An Industry Survey.

The correct name of the second author should be "Moritz Fehrle", and not "Mortiz Fehrle" as given in the original publication of the article.

Adverse Drug Reaction Case Safety Practices in Large Biopharmaceutical Organizations from 2007 to 2017: An Industry Survey.

Introduction: Drug safety remains a top global public health concern. An increase in the number of data sources available has increased the complexity of pharmacovigilance operations, so the US FDA has created draft guidance focusing on optimizing drug safety data for well-characterized medicines. However, to date, no data demonstrating changes in reports have been presented.

Deconstructing the Pharmacovigilance Hype Cycle.

Data science is making increasing contributions to pharmacovigilance. Although the technical innovation of these works are indisputable, efficient progress in real-world pharmacovigilance signal detection may be hampered by corresponding technology life cycle effects, with a resulting tendency to conclude that, with large enough datasets and intricate algorithms, "the numbers speak for themselves," discounting the importance of clinical and scientific judgment. A practical consequence is overzealous declarations regarding the safety or lack of safety of drugs.

Innovation in Pharmacovigilance: Use of Artificial Intelligence in Adverse Event Case Processing.

Automation of pharmaceutical safety case processing represents a significant opportunity to affect the strongest cost driver for a company's overall pharmacovigilance budget. A pilot was undertaken to test the feasibility of using artificial intelligence and robotic process automation to automate processing of adverse event reports. The pilot paradigm was used to simultaneously test proposed solutions of three commercial vendors.

Validation of New Signal Detection Methods for Web Query Log Data Compared to Signal Detection Algorithms Used With FAERS.

Introduction: Post-marketing drug surveillance is largely based on signals found in spontaneous reports from patients and healthcare providers. Rare adverse drug reactions and adverse events (AEs) that may develop after long-term exposure to a drug or from drug interactions may be missed. The US FDA and others have proposed that web-based data could be mined as a resource to detect latent signals associated with adverse drug reactions.

Assessment of dronedarone utilization using US claims databases.

Background: A dronedarone utilization study using US MarketScan and InVision Data Mart databases was conducted to estimate the prevalence of the following: (1) dronedarone use in contraindicated patients with worsening heart failure (HF) or hospitalization for HF within 1 month before dronedarone prescription; (2) concomitant prescribing of contraindicated drugs; and (3) recommended creatinine testing after dronedarone initiation among dronedarone users.

Methods: In this retrospective cohort study, data in the MarketScan database between July 20, 2009, and December 31, 2011, and in the InVision Data Mart database between July 20, 2009, and March 31, 2012, were analyzed. The study population included patients who received ≥1 dronedarone prescription during the study period.

Risk of Cardiovascular Events, Stroke, Congestive Heart Failure, Interstitial Lung Disease, and Acute Liver Injury: Dronedarone versus Amiodarone and Other Antiarrhythmics.

No published studies have evaluated the risks of cardiovascular (CV) events, stroke, congestive heart failure (CHF), interstitial lung disease (ILD), and severe acute liver injury (ALI) related to antiarrhythmics treatment in real-world clinical practice setting. We examined the relationship between the above events and the selected antiarrhythmics in the real-world setting in the US. Using a retrospective cohort design, the hazard ratios of the outcome events were analyzed from 10,455 adult patients with a diagnosis of atrial fibrillation/atrial flutter and a new treatment with dronedarone (comparison drug), amiodarone, sotalol, flecainide, or propafenone between 07/20/2009 and 12/31/2010 from the Clinformatics Data MartTM database.

Amenorrhea due to partial uterine necrosis after uterine artery embolization for control of refractory postpartum hemorrhage.

We report a case of a woman in whom selective embolization of both uterine arteries was performed using gelatin sponge for control of refractory postpartum hemorrhage. Ten months after delivery, the women had not resumed noticeable menstruation. Examination and investigation were consistent with partial uterine necrosis and complete obliteration of the cavity.

The effect of continuous oestradiol with intermittent norgestimate on bone mineral density and bone turnover in post-menopausal women.

Objective: To assess in post-menopausal women the efficacy and tolerability of a continuous oestradiol/intermittent norgestimate HRT regimen to prevent and to reverse post-menopausal loss of bone mineral density (BMD) and to determine the effects on serum bone turnover markers markers.

Methods: A 1-year, multicentre, international, placebo-controlled, randomised, double-blind clinical trial was conducted in 146 post-menopausal women with an intact uterus in order to assess the effect on bone loss of continuous oral 17beta-oestradiol (1 mg per day) combined with norgestimate (90 microg per day), for 3 consecutive days out of every 6-day treatment period (E2/iNGM). During a second year extension, all women agreeing to continue were on the E2/iNGM regimen.

Feto-maternal alloimmune thrombocytopenia due to HPA-5b incompatibility: a case report.

Feto-maternal alloimmune thrombocytopenia (FMAIT) results from the maternal production of antibodies against fetal platelets with incompatible antigens inherited from the father. We present a case where this condition was diagnosed prenatally without previously affected siblings. The severe fetal thrombocytopenia was due to anti-HLA-5b maternal alloantibodies.

Norelgestromin as selective estrogen enzyme modulator in human breast cancer cell lines. Effect on sulfatase activity in comparison to medroxyprogesterone acetate.

Human breast cancer tissue contains enzymes (estrone sulfatase, 17beta-hydroxysteroid dehydrogenase, aromatase) involved in the last steps of estradiol (E(2)) formation. In this tissue, E(2) can be synthesized by two main pathways: (1) sulfatase-transforms estrogen sulfates into bioactive E(2), and the (2) aromatase-converts androgens into estrogens. Quantitative assessment of E(2) formation in human breast tumors indicates that metabolism of estrone sulfate (E(1)S) via the sulfatase pathway produces 100-500 times more E(2) than androgen aromatization.

Intermittent progestin administration as part of hormone replacement therapy: long-term comparison between estradiol 1 mg combined with intermittent norgestimate and estradiol 2 mg combined with constant norethisterone acetate.

Background: To decrease exposure to progestin during hormone replacement therapy (HRT), a novel oral regimen consisting of constant 17beta-estradiol (E2) daily plus intermittent norgestimate (NGM) has been developed.

Methods: A multicenter study compared the safety and efficacy of E2 1 mg daily plus intermittent NGM 90 micro g (3 days off, 3 days on) (n = 150) vs. a continuous oral dose of E2 2 mg plus norethisterone acetate (NETA) 1 mg (n = 172) daily, for a period of 2 years.

Constant estrogen, intermittent progestogen vs. continuous combined hormone replacement therapy: tolerability and effect on vasomotor symptoms.

Objective: To compare the efficacy and tolerability of a novel oral constant estrogen plus intermittent progestogen hormone replacement therapy (HRT) regimen to a continuous combined HRT regimen in postmenopausal women.

Methods: Subjects were randomly assigned to receive treatment with either constant 17beta-estradiol (E2), 1 mg, plus intermittent norgestimate (NGM) 90 microg (3 days off, 3 days on) (n=221) or E2 2 mg/norethisterone acetate (NETA) 1 mg (n=217) for 1 year. Treatments were evaluated based on the incidence of hot flushes and uterine bleeding.

Effects on serum lipid profiles of continuous 17beta-estradiol, intermittent norgestimate regimens versus continuous combined 17beta-estradiol/norethisterone acetate hormone replacement therapy.

Objective: To compare the effects of a daily oral 1-mg dose of continuous 17beta-estradiol (E2) plus intermittent (3 days off, 3 days on) norgestimate (NGM) 90 microg (n = 221), an oral 2-mg dose of continuous E2 plus intermittent NGM 180 microg (n = 219), and an oral 2-mg dose of continuous E2 plus continuous norethisterone acetate (NETA) 1 mg (n = 217) on blood lipids and lipoproteins in postmenopausal women.

Background: The present study was undertaken because some progestins have adverse effects on lipid profiles, thereby negating the favorable effects of estrogens.

Methods: This was a multicenter, randomized, parallel-group trial that focused primarily on the 2 marketed regimens--E2 1 mg/NGM 90 microg and E2/NETA.

Effects of maternal dexamethasone administration on fetal Doppler flow velocity waveforms.

Objective: To investigate the effects of maternal dexamethasone administration on umbilical and fetal cerebral artery flow velocity waveforms.

Design: Cross-sectional study.

Setting: Department of Obstetrics and Gynaecology, Robert Ballanger Hospital, Aulnay-sous-Bois, France.

Absence of flow velocity waveform changes in uterine arteries after bilateral internal iliac artery ligation.

A case is reported of bilateral internal iliac artery ligation during cesarean delivery for intractable hemorrhage. Uterine artery Doppler flow velocity waveforms were documented before and after the procedure. After the ligation the uterine arteries could still be visualized in the appropriate anatomic location, and no changes in Doppler flow velocity waveforms were documented.