Analysis of the Drugs Withdrawn from the US Market from 1976 to 2010 for Safety Reasons
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ORIGINAL RESEARCH ARTICLE
Analysis of the Drugs Withdrawn from the US Market from 1976 to 2010 for Safety Reasons Pierre La Rochelle1 • Joel Lexchin2,3 • David Simonyan4
Published online: 12 September 2016 Ó Springer International Publishing Switzerland 2016
Abstract Objective This study reviews the use of different study designs used to generate evidence to justify drug withdrawals for safety reasons in the United States (US). Secondarily it examines the most common reasons for withdrawing drugs, how long the withdrawn drugs were on the market and uses statistical modeling to estimate the risk of withdrawal over time. Methods A list of drugs withdrawn from the US market for safety reasons was generated, along with the corresponding period of time each drug was marketed. Evidence used to justify the withdrawal was obtained from searching Drugs@FDA and PubMed, and evidence was classified according to the study design used to generate the evidence. The number of drugs withdrawn was plotted as a function of how long they were marketed and a mathematical model was derived from this set of data to calculate the mean time the drugs were marketed before withdrawal. Results A total of 34 drugs were withdrawn from the market for safety reasons in the US from 1976 to 2010. Nineteen of
& Pierre La Rochelle [email protected] David Simonyan [email protected]
the 34 withdrawals relied only on case reports. Randomized and non-randomized studies were identified in 15 withdrawals and were increasingly used over the period of time examined. The median length of time that drugs were on the market was 3.4 years [interquartile range (IQR), 1.2, 10.4 years] with a mode at 1 year. The longest marketing period before withdrawal in the current data set was 53 years. Most drugs were withdrawn for either arrhythmias, hepato-renal failure or other cardiovascular problems. Conclusions The evidence used to justify safety withdrawals is dominated by case reports although there is an increased use of comparative studies.
Key Points Despite the poor quality of evidence from case reports and case series, they play a major role in the justification of drug withdrawals for safety reasons. Comparative trials, especially randomized controlled trials, are being increasingly used to generate evidence for withdrawals. The risk of a new drug being withdrawn from the market depends on how long it has been on the market and the risk can be mathematically modeled.
1
De´partement de me´decine familiale et me´decine d’urgence, Universite´ Laval, 1201, 6e ave, La Pocatie`re, (Que´bec) G0R 1Z0, Canada
2
School of Health Policy and Management, York University, Toronto, Canada
1 Introduction
Emergency Department, University Health Network, Toronto, Canada
The evolving level of knowledge used to ascertain the benefits of new drugs over the last half of the twentieth century is reflected in the hierarchy of evidence used to structure medical knowledge and enhance decision making
3
4
Plateforme de recherche clinique et
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