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Label updates are for serious adverse effects discovered after original clinical trials

Tuesday, December 7, 2010 (Last Updated: 12/08/2010)

TUESDAY, Dec. 7 (HealthDay News) -- Many serious or potentially fatal adverse reactions associated with new, targeted anticancer agents are not reported in the original published research on the drug and are not known to oncologists until years later, when updated drug labels, including boxed warnings, are required, according to research published online Dec. 6 in the Journal of Clinical Oncology.

Bostjan Seruga, M.D., of the University of Toronto, and colleagues conducted a review of 12 targeted anticancer agents with updated drug labels due to safety concerns and 36 corresponding randomized controlled trials (RCTs) referenced in the updated labels. The purpose of the study was to analyze adverse drug reactions (ADRs) of targeted anticancer agents reported after the publication of the RCTs.

In the updated drug labels, there were 76 serious ADRs reported; half of these were potentially fatal. The researchers found that the corresponding RCTs for the targeted anticancer agents did not describe 39 percent of serious ADRs and 39 percent of potentially fatal ADRs, and the initial drug label did not describe 49 percent of serious ADRs and 58 percent of potentially fatal ADRs. Between initial approval and update of drug labels (a median 4.3 years), 42 percent of targeted cancer agents were given one or more U.S. Food and Drug Association boxed warnings, which are the highest FDA alert level.

"In conclusion, many rare but serious and potentially fatal ADRs associated with targeted anticancer agents are not reported in the corresponding pivotal RCTs and in the initial drug labels. These ADRs may be important causes of morbidity and mortality in general oncologic practice," the authors write.

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Specialties Hematology & Oncology

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