INNOVATIONS in pharmacy

Comparison of Drug Withdrawal Processes in the U.S. and Other Nations

Hinal Patel

Ferris State University College of Pharmacy

Albert Wertheimer

College of Pharmacy, Nova Southeastern University

Qian Ding

Ferris State University College of Pharmacy

DOI: https://doi.org/10.24926/iip.v12i3.3939

Keywords: Drug withdrawal, drug recall, recall procedure, adverse drug reactions, drug toxicity

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Abstract

Medications have been withdrawn from as early as the 1900’s in several countries due to a variety of reasons. Most drugs have been withdrawn due to safety, efficacy, manufacturing issues, or the toxicities they address.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paper explores the drug withdrawal process in several countries due to hepatic and cardiovascular toxicities using the WITHDRAWN database.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.