TY - JOUR T1 - New drugs and safety: What happened to new active substances approved in canada between 1995 and 2010? AU - Lexchin J Y1 - 2012/11/26 N1 - 10.1001/archinternmed.2012.4444 JO - Archives of Internal Medicine SP - 1680 EP - 1681 VL - 172 IS - 21 N2 - Monitoring the safety of drugs is increasingly recognized as a major issue in light of recent experience with products such as rofecoxib and rosiglitazone. Previous work found that the probability of new drugs either acquiring a black box safety warning or being withdrawn for safety reasons was 20% over a 25-year period1 and that oncology drugs that were granted a priority review were more likely to be subject to labeling changes than were drugs with a standard review.2 SN - 0003-9926 M3 - doi: 10.1001/archinternmed.2012.4444 UR - http://dx.doi.org/10.1001/archinternmed.2012.4444 ER -