RT Journal
A1 Lexchin J
T1 New drugs and safety: What happened to new active substances approved in canada between 1995 and 2010?
JF Archives of Internal Medicine
JO Archives of Internal Medicine
YR 2012
FD November 26
VO 172
IS 21
SP 1680
OP 1681
DO 10.1001/archinternmed.2012.4444
UL http://dx.doi.org/10.1001/archinternmed.2012.4444
AB 
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 Previous work found that the probability of new drugs either acquiring a black box safety warning or being withdrawn for safety reasons was 20% over a 25-year period1 and that oncology drugs that were granted a priority review were more likely to be subject to labeling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