Accelerated FDA approval of cancer drugs is associated with post-marketing identification of common, but potentially fatal adverse drug reactions (ADRs) Abstract No: 2093 Category: Health Services Research Author(s): C. L. Bennett, L. A. Ladewski, A. R. Auerbach, E. A. Lyons, B. Kim; Northwestern University Feinberg School of Medicine, Chicago, IL Abstract: Background: Accelerated approval in the FDA allows the marketing of oncology medications prior to formal demonstration of patient benefit. The potential effects of this process on the occurrence of adverse drug reactions have not been studied. Methods: All potentially fatal ADRs with oncology drugs reported in 2000-2002 in Medline, the FDA's MedWatch database, and "Dear Doctor" letters were reviewed. Potentially fatal ADRs were defined as those which resulted in fatalities; were treated with intubation, dialysis etc; or were described in "Dear Doctor" letters or black box warnings, warnings, or contraindications sections in revised package inserts (PIs). Seventeen potentially fatal ADRs were identified for 16 drugs with standard FDA approvals and 7 ADRs were identified with 5 drugs with accelerated approvals. Results: ADRs were reported at a median of 7 years after FDA approval. Rates for common ADRs, derived from clinical trials (six ADRs) and single institution reports (one ADR), ranged from 3% to 33%. Rates for less frequent ADRs were usually derived from MedWatch reports. ADRs were described in 17 PI revisions (median 5.4 yrs after approval), 17 journal articles (median 3 yrs), and 12 "Dear Doctor" letters (median 4.9 yrs). The 7 ADRs associated with drugs with accelerated FDA approvals were more likely than the 17 ADRs associated with drugs with standard approvals to be identified shortly after approval (median of 1.0 vs 10.7 years, p<0.05), have occurrence rates >1% (100% vs 6%, p<0.0001), and be identified in clinical trials (71% vs 14%, p<0.05). The study drugs with accelerated and standard FDA approvals had similar numbers of patients in licensing trials (median of 223 vs 169 patients), although the time from new drug application to FDA approval was shorter for accelerated approval drugs (80% vs 27% approved in < 8 months, p< 0.05) and they were more likely to have undergone priority review (80% vs 6%, p<0.001). Conclusion: Focused post-marketing safety studies should be conducted for cancer drugs that receive accelerated FDA approval. Remember we are NOT Doctors and have NO medical training. This site is like an Encylopedia - there are many pages, many links on many topics. Support our work with any size DONATION - see left side of any page - for how to donate. You can help raise awareness of CAM.