Paper Details
- Home
- Paper Details
Adverse event reporting patterns of newly approved drugs in the USA in 2006: an analysis of FDA Adverse Event Reporting System data.
Author: ChenXing, ChhabraPankdeep, WeissSheila R
Original Abstract of the Article :
The Weber effect states that adverse event (AE) reporting tends to increase in the first 2 years after a new drug is placed onto the market, peaks at the end of the second year, and then declines. However, since the Weber effect was originally described, there has been improvement in the communicati...See full text at original site
Dr.Camel's Paper Summary Blogラクダ博士について
ラクダ博士は、Health Journal が論文の内容を分かりやすく解説するために作成した架空のキャラクターです。
難解な医学論文を、専門知識のない方にも理解しやすいように、噛み砕いて説明することを目指しています。
* ラクダ博士による解説は、あくまで論文の要点をまとめたものであり、原論文の完全な代替となるものではありません。詳細な内容については、必ず原論文をご参照ください。
* ラクダ博士は架空のキャラクターであり、実際の医学研究者や医療従事者とは一切関係がありません。
* 解説の内容は Health Journal が独自に解釈・作成したものであり、原論文の著者または出版社の見解を反映するものではありません。
引用元:
https://doi.org/10.1007/s40264-013-0115-x
データ提供:米国国立医学図書館(NLM)
Investigating Adverse Event Reporting Trends for Newly Approved Drugs
The field of drug safety surveillance is continually evolving, and the dynamics of adverse event (AE) reporting are a crucial aspect of this evolution. This study explores the reporting patterns of newly approved drugs, examining the validity of the Weber effect, which suggests an initial surge in AE reports followed by a gradual decline. The authors, like desert explorers uncovering a new route, investigate the influence of improved communication and reporting policies on the traditional AE reporting pattern. The study suggests that while the Weber effect may still hold true in some cases, the evolution of drug safety communication and reporting practices has altered the traditional trend.
Evolving Trends in Adverse Event Reporting
The study's findings suggest that the initial spike in AE reports for new drugs might be less pronounced due to improved communication and reporting mechanisms. This highlights the positive impact of enhanced safety information dissemination and proactive reporting by healthcare professionals and consumers.
Navigating the Landscape of Drug Safety
This research underscores the need for ongoing vigilance in drug safety monitoring. The study emphasizes the importance of continuous data analysis and adaptation of reporting practices to ensure the safety of newly approved drugs. This vigilance is critical for protecting patient safety and optimizing drug development.
Dr.Camel's Conclusion
This study underscores the need for a comprehensive approach to drug safety monitoring, acknowledging the evolving dynamics of AE reporting. By understanding these patterns and incorporating feedback from healthcare professionals and consumers, we can work towards a safer and more transparent drug development and surveillance process.
Date :
- Date Completed 2014-06-06
- Date Revised 2021-10-21
Further Info :
Related Literature
English
This site uses cookies. Visit our privacy policy page or click the link in any footer for more information and to change your preferences.