High incidence of Thalidomide-Associated Deep Vein Thrombosis (DVT) and Pulmonary Emboli (PE) when Chemotherapy is also administered

Reviewer: William Levin, MD
The Abramson Cancer Center of the University of Pennsylvania
Last Modified: December 13, 2001

Presenter: Alan Liehten
Presenter's Affiliation: University of Chicago
Type of Session: Scientific


  • Thalidomide is a sedative/anti-emetic that was given to women from 1956-1962.
  • Some 12,000 birth defects have been attributed to the use of this drug.
  • Today thalidomide is used in the treatment of multiple myeloma and leprosy.
  • Recently, concern has been increasing regarding the incidence of thromboenbolic events in these patients.
  • The purpose of the current study was to describe the clinical characteristics that predispose this population to PE or DVT.

    Materials and Methods

  • Information on thalidomide-associated thromboembolic events was obtained from MedWatch, the FDA's adverse events reporting system (67 pts), and physicians (29 pts).
  • Incidence reports were obtained from 12 phase II trials and one phase III trial.
  • An adverse event was defined as a clinically or radiographically confirmed DVT or PE in a pt using thalidomide.


  • 48 cases of DVT, 25 cases of PE, and 23 cases of DVT with PE were reported.
  • The mean time of thrombotic event after thalidomide use was 60 days.
  • Concomitant use of medications, including chemotherapy (34 cases), and corticosteroids (44 cases).
  • In one phase III clinical trial, 100 multiple myeloma patients receiving chemotherapy either with or without thalidomide. 28% of the thalidomide group and 6% of the non-thalidomide group developed thrombotic complications (p=0.006).

    Author's Conclusions
    Cancer pts may be at increased risk for the development of thromboembolic events following initiation of thalidomide, especially when the drug is given concomitantly with chemotherapy.

    Clinical/Scientific Implications

  • This study underscores the importance of reporting adverse events.
  • Although further testing is needed, it may be reasonable to consider prophylactic anticoagulation in this population of patients.

    Oncolink's ASH Coverage made possible by an unrestricted Educational Grant from Amgen.

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