Patel Hinal, Wertheimer Albert, Ding Qian
Ferris State University College of Pharmacy.
College of Pharmacy, Nova Southeastern University.
Innov Pharm. 2021 Jun 10;12(3). doi: 10.24926/iip.v12i3.3939. eCollection 2021.
Medications have been withdrawn from as early as the 1900's in several countries due to a variety of reasons. Most drugs have been withdrawn due to safety, efficacy, manufacturing issues, or the toxicities they address. While safety and efficacy of each new drug is taken into account, so is the process of drug withdrawal. Worldwide each country has its own medical agency which have different approaches on drug discovery and method of removal from the market. This removal process is simpler in several nations while more prolonged in others. Nevertheless, we still don't know an effective method of drug removal from the market and therefore that is the focus of this paper. This paper explores the drug withdrawal process in several countries due to hepatic and cardiovascular toxicities using the WITHDRAWN database. It also summarizes and compares the drug removal processes in the U.S., Australia, UK, EU, and Canada. Consequently, there was no data or evidence that supported one country more favorable or rapid than the other. However, based on the results from drug withdrawal processes, it appeared the U.S., UK, and EU were most comparable. Meanwhile, Australia appeared to have the lengthiest process.
早在20世纪初，一些国家就因各种原因撤回了药物。大多数药物被撤回是由于安全性、有效性、生产问题或它们所针对的毒性。虽然每种新药的安全性和有效性都被考虑在内，但药物撤回过程也是如此。在全球范围内，每个国家都有自己的医疗机构，它们在药物研发和从市场上撤药的方法上有不同的做法。在一些国家，这个撤药过程比较简单，而在其他国家则比较漫长。然而，我们仍然不知道一种有效的从市场上撤药的方法，因此这就是本文的重点。本文利用“撤回药物”数据库探讨了几个国家因肝脏和心血管毒性而进行的药物撤回过程。它还总结并比较了美国、澳大利亚、英国、欧盟和加拿大的药物撤药过程。因此，没有数据或证据表明一个国家比另一个国家更有利或撤药速度更快。然而，根据药物撤回过程的结果，美国、英国和欧盟似乎最为相似。与此同时，澳大利亚的撤药过程似乎最长。
