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Applications of RWE for Regulatory Uses
Published in Kelly H. Zou, Lobna A. Salem, Amrit Ray, Real-World Evidence in a Patient-Centric Digital Era, 2023
Eleanor E. Panico, Corinne S. Pillai, Ewa Filipowska, Kelly H. Zou
In the US, for example, post-marketing AE-reporting is governed by the regulation in 21 CFR 314.80 (Post marketing reporting of adverse drug experiences, eCFR) which defines an adverse drug experience as; “any undesirable event that is associated with the use of a drug in humans, whether or not considered drug-related and occurs in the course of the use of a drug product in professional practice. This may include drug overdose, drug abuse, drug withdrawal, any failure of expected pharmacologic action.” This regulation requires sponsors to submit post-marketing safety reports, known as 15-day alerts for serious and unexpected adverse experience (foreign and domestic), as well as periodic adverse experience reports containing domestic spontaneous AEs that are serious/expected, non-serious/unexpected, non-serious/expected. Such reports are typically required quarterly for the first three years following a new drug launch market, and annually thereafter. These safety updates can eventually be a component of a drug application’s annual NDA/IND annual report (CFR – Code of Federal Regulations Title 21). The FDA’s Adverse Event Reporting System, also known as FAERS, is a fully automated computerized database designed to support FDA’s post-marketing safety surveillance program for drugs and biologics (Questions and Answers on FDA’s Adverse Event Reporting System (FAERS)).
Orthomolecular Approaches for the Use of Intravenous Vitamin C
Published in Qi Chen, Margreet C.M. Vissers, Cancer and Vitamin C, 2020
Common reported reasons for treatment included infection, cancer, and fatigue. Of 9328 patients for whom data are available, 101 had side effects, mostly minor, including lethargy/fatigue in 59 patients, short-lived change in mental status in 21 patients, and vein irritation/phlebitis in 6 patients. Review of the published literature documented serious adverse events, including two deaths in patients known to be at risk for receiving IVC. Secondary to multiple prescribed medications and associated underlying chronic illness, the FDA Adverse Event Reporting System database was uninformative for specific information pinpointing adverse events directly related to IVC.
Pharmaceutical and Medical Device Product Liability Litigation
Published in Julie Dickinson, Anne Meyer, Karen J. Huff, Deborah A. Wipf, Elizabeth K. Zorn, Kathy G. Ferrell, Lisa Mancuso, Marjorie Berg Pugatch, Joanne Walker, Karen Wilkinson, Legal Nurse Consulting Principles and Practices, 2019
Vicki W. Garnett, Stacy Newsome
Unfortunately, adverse events related to drugs and devices do occur, and the FDA established a reporting system to conduct post-marketing surveillance and risk assessment programs to track adverse effects. As previously discussed, pharmaceutical and biologic products undergo extensive evaluation through the clinical trial process, and consumers can assume a reasonable expectation the drug will be safe and effective if consumed for the approved indication and dosage and the consumer adheres to the instructions outlined in the drug label. However, when a new drug is released to a broader population, post-marketing side effects are identified, and additional testing is sometimes required. The FDA Adverse Event Reporting System (FAERS; USFDA, n.d.-a, n.d.-e) is a database used to track, store, and analyze post-marketing safety surveillance reports. Reports are evaluated by CDER scientists to monitor and enforce drug safety. Based on CDER’s analysis, the FDA may enforce regulatory action such as requiring the pharmaceutical manufacturer to revise the drug label, include a black box warning, send out a “Dear Health Care Professional” letter, or withdraw the product from the market (USFDA, n.d.-g).
The Association Between Taxane Use and Lacrimal Disorders
Published in Current Eye Research, 2023
Gerald McGwin, Tucker Contorno, Matthew G. Vicinanzo, Cynthia Owsley
The US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) is a publicly available database that documents adverse events associated with prescription and over-the-counter medications. Adverse events are voluntarily reported to FAERS by healthcare providers, drug manufacturers, lawyers, and members of the public. In addition to its use as a post-marketing surveillance tool, FAERS is also used for research purposes. Adverse event reports can include the following information:1 patient demographics2 administrative information:3 information on the drug involved;4 Information on the adverse event;5 patient outcome information;6 reporting source for adverse events;7 information on therapeutics (drug start date); and8 indications for use of the reported drugs. With respect to information on therapeutics, the name of the product appears verbatim, and therefore any given drug may be identified by its trade or generic name. Missing information for individual data fields is common in adverse event reports.
Skin cancer signal associated with phosphodiesterase inhibitors: gaining insight through the FDA pharmacovigilance database
Published in Expert Opinion on Drug Safety, 2023
Jun-Wei Chow, Ming-Ming Yan, Hui Zhao, Zi-Ran Li, Qian Zhang, Ming-Kang Zhong, Xiao-Yan Qiu
Serious ADRs associated with PDE5A inhibitors are a major public health concern. Clinical trials aim to ensure the safety and efficacy of these drugs in the average population; however, rare safety outcomes are hard to anticipate. Small cohort sizes, short study durations, and other known clinical trial limitations pose as a severe threat. The real-world risk of PDE5A inhibitors-associated cancer requires evaluation. The FDA Adverse Event Reporting System (FAERS) plays a crucial role in supporting the FDA post-marketing safety surveillance program, which monitors the safety and effectiveness of drugs and therapeutic biologic products available in the US market. FAERS has been a useful tool for accurately detecting drug safety issues not recognized in the pre-marketing clinical trials, such as pioglitazone-associated bladder cancer and clozapine-associated hematologic malignancies [14,15]. The aim of this study was to investigate the association between PDE5A inhibitors and cancer signal, while distinguishing the potential risk for different cancers among erectile dysfunction patients.
Evaluation of uveitis events in real-world patients receiving immune checkpoint inhibitors based on the FAERS database
Published in Cutaneous and Ocular Toxicology, 2023
Qianqian Fan, Huan Chen, Yang Hu, Bin Zhao
This study has several limitations. First, the spontaneous adverse event reports can be filled out online through the FAERS by healthcare professionals, consumers, or manufacturers. The nature of this reporting mode may generate bias because data missing, spelling mistakes and inaccurate descriptions may influence the data quality. For example, there were 20 death cases in this study which might relate to other concurrent irAEs or malignant progressions due to adverse event-related treatment discontinuation. It is difficult to avoid such reporting bias, but the general outcomes of ICI-related uveitis could be observed from the results. Second, the database lacks detailed information of the patients, like previous uveitis history or other concomitant drugs with ocular toxicities, which may result in unmeasured confounding factors that influence the results. We used four data mining algorithms to reduce these effects, but cannot fully eliminate them. Third, the incidence of ICI-related uveitis cannot be obtained from this study which was carried out based on reported events rather than the events that occur. Finally, we cannot determine the drug-event causality, since FDA does not require a proved causal relationship between a product and an event when reporting. Despite these limitations, our analysis of the FAERS data sheds light on the statistical associations between uveitis and multiple ICI regimens, which helps improve the understanding of this rare adverse drug effect and provide implications for in-depth studies on this safety issue.