Thalidomide (thal), Lenalidomide (len), and Dexamethasone (dex)-Associated Venous Thromboembolism (VTE) and Reported VTE Rates Pre- and Post-FDA Approval: Optimal Prophylaxis Strategies Are Still Unclear

Background: We previously reported that thal and len administration was associated with high VTE rates, particularly for multiple myeloma (JAMA 2006). The Connecticut Attorney General filed a Citizen's Petition in 2005 with the FDA highlighting this safety concern. In 2006, when the FDA granted approval to thal and len to treat multiple myeloma patients, the FDA upheld much of the Petition and the sponsor included a Black Box warning to package inserts for both drugs when administered to MM patients, and encouraged consideration of VTE prophylaxis (although optimal strategies were not known). Herein, to compare the len/thal/dex-associated VTE rates pre- and post-FDA approval, the Research on Adverse Drug Events and Reports (RADAR) project performed a literary search through Pubmed and Ovid, with the search terms: “VTE,” “thrombosis,” “thromboembolism,” “DVT,” “multiple myeloma,” “thalidomide,” and “lenalidomide.”