Results 11 to 20 of about 3,632 (145)

Serious Infection in Crohn's Disease Patients Treated With Ustekinumab: US Food and Drug Administration Active Postmarket Risk Identification and Analysis in the Sentinel Initiative. [PDF]

Clin Pharmacol Ther
The U.S. Food and Drug Administration (FDA) used an Active Postmarket Risk Identification and Analysis (ARIA) system to address a safety issue (serious infection) identified during clinical review of an application to market ustekinumab as a treatment for Crohn's disease (CD). FDA used an active‐comparator new‐user cohort design, data from six Sentinel
Weissfeld JL, Iyer GS, Seo SC, Giffin A, Simon AL, Kluberg SA, Hoffman ER, Jones JT, Dutcher SK, Korvick JA.   +9 more
europepmc   +2 more sources

Development, Production, and Postmarketing Surveillance of Hepatitis A Vaccines in China

Journal of Epidemiology, 2014
China has long experience using live attenuated and inactivated vaccines against hepatitis A virus (HAV) infection. We summarize this experience and provide recent data on adverse events after immunization (AEFIs) with hepatitis A vaccines in China.
Cui, Fuqiang, Liang, Xiaofeng, Wang, Fuzhen, Zheng, Hui, Hutin, Yvan J, Yang, Weizhong   +5 more
openaire   +3 more sources

Postmarket surveillance: a review on key aspects and measures on the effective functioning in the context of the United Kingdom and Canada

Therapeutic Advances in Drug Safety, 2019
Regulatory approvals for the marketing of medicinal products authorize medical practitioners to prescribe drugs to a group of patients that are defined within the license of the medicinal product.
Nikhil Raj, Swapnil Fernandes, Narayana R. Charyulu, Akhilesh Dubey, Ravi G. S., Srinivas Hebbar   +5 more
doaj   +1 more source

Impact of body mass index on the efficacy and safety of ipragliflozin in Japanese patients with type 2 diabetes mellitus: A subgroup analysis of 3‐month interim results from the Specified Drug Use Results Survey of Ipragliflozin Treatment in Type 2 Diabetic Patients: Long‐term Use study

Journal of Diabetes Investigation, 2019
Aims/Introduction Specified Drug Use Results Survey of Ipragliflozin Treatment in Type 2 Diabetic Patients: Long‐term Use is an ongoing postmarketing study of ipragliflozin for long‐term use in Japanese patients with type 2 diabetes mellitus.
Kazuyuki Tobe, Hiroshi Maegawa, Hiromi Tabuchi, Ichiro Nakamura, Satoshi Uno   +4 more
doaj   +1 more source

A Blockchain-Based Post-Marketing Surveillance System for Medical Devices [PDF]

مجله علوم پزشکی صدرا
Nowadays, medical devices are widely used around the world. In every country, the safety of these devices is inextricably related to public health and security.
Ali Tavakoli Golpaygani, Fereshteh-Azadi Parand, Mohammad Amin Keshavarz   +2 more
doaj   +1 more source

Occurrence of Pulmonary Oil Microembolism After Testosterone Undecanoate Injection: A Postmarketing Safety Analysis

Sexual Medicine, 2020
Background: The Aveed Risk Evaluation and Mitigation Strategy program was instituted because of potential risk of pulmonary oil microembolism (POME) and/or anaphylaxis after intramuscular injection of Aveed (testosterone undecanoate), indicated for ...
Alexander W. Pastuszak, MD, PhD, Yiqun Hu, MD, PhD, Jeffrey D. Freid, MD   +2 more
doaj   +1 more source

Postlicensure safety surveillance of congenital anomaly and miscarriage among pregnancies exposed to quadrivalent human papillomavirus vaccine

Human Vaccines & Immunotherapeutics, 2018
Limited safety data are available on inadvertent exposure to quadrivalent human papillomavirus vaccine (4vHPV) during pregnancy. We conducted a descriptive observational postlicensure safety surveillance study in Kaiser Permanente Southern California and
Lina S. Sy, Kristin I. Meyer, Nicola P. Klein, Chun Chao, Christine Velicer, T. Craig Cheetham, Bradley K. Ackerson, Jeff M. Slezak, Harpreet S. Takhar, John Hansen, Kamala Deosaransingh, Kai-Li Liaw, Steven J. Jacobsen   +12 more
doaj   +1 more source

Post-Marketing Surveillance of a generic Oxaliplatin (AlvoxalⓇ) in Iranian Patients with Cancer

Current Therapeutic Research, 2022
: Background: CRC is the second and third most common cancer in women and men, respectively. The national comprehensive cancer network guidelines recommend oxaliplatin-based chemotherapy as a preferred regimen for patients with advanced or metastatic ...
Farhad Shahi, Mojtaba Gorji, Assistant Professor of Pediatric Oncology, Mehrdad Payandeh, Assistant Professor of Hematology & Oncology, Hamid Rezvani, Associate Professor of Hematology & Oncology, Mohammad Vaezi, Associate Professor of Hematology & Oncology, Sharareh Seifi, Assistant Professor of Hematology & Oncology, Alireza Baari, Post doctoral fellowship, Reza Khalili-Dizaji, Post doctoral fellowship, Seyed Mehdi Hashemi, Associate Professor of Hematology & Oncology, Saeid Salimi, post doctoral fellowship, Hosein Kamranzadeh, Associate Professor of Hematology & Oncology, Babak Shazad, Post doctoral fellowship, Sina Salari, Associate Professor of Hematology & Oncology, Davoud Oulad Dameshghi, Assistant Professor of Hematology & Oncology, Mehdi Sarkheil, Post doctoral fellowship, Mehrzad Mirzania, Associate Professor of Hematology & Oncology, Nassim Anjidani, Pharm. D.   +16 more
doaj   +1 more source

The Role of Pharmacovigilance Database in Identifying Antibiotic Resistance and Inappropriate Use: An Analysis of VigiBase Reports From Lower-Middle-Income Countries. [PDF]

Pharmacoepidemiol Drug Saf
ABSTRACT Background Digital databases such as pharmacovigilance (PV) databases could provide unique opportunities to monitor trends in suspected antibiotic resistance, ineffectiveness, and misuse, extending beyond their traditional role of tracking adverse drug reactions (ADRs).
Saleh H, Mitchell J, Lundborg CS, Sharma M.   +3 more
europepmc   +2 more sources

Actions to mitigate ocular adverse events related to hair styling cosmetics in Brazil: a descriptive and correlational study (2022-2024) [PDF]

Epidemiologia e Serviços de Saúde
Objective To describe health surveillance actions implemented by the Brazilian Health Regulatory Agency (ANVISA) to mitigate cases of ocular adverse events related to hair styling creams in Brazil and verify correlation between reported cases and these ...
Daniel Marques Mota, Leonardo Oliveira Leitão, Ronald Santos Silva, Cássia de Fátima Rangel Fernandes, Marcus Tolentino Silva   +4 more
doaj   +1 more source