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Title: Thalidomide Appears Safe for Men on Warfarin: Presented at ACCP

"Thalidomide Appears Safe for Men on Warfarin: Presented at ACCP"

By Crystal Phend WASHINGTON, DC -- September 19, 2005 -- Thalidomide (Thalomid) appears to be safe for co-administration with warfarin in men, according to a study presented here at the annual meeting of the American College of Clinical Pharmacology (ACCP) on September 11[^th.

Lead author Anfan Wu, PhD, Associate Director of Clinical Pharmacology, Celgene, Summit, New Jersey, United States, presented the findings.

Thalidomide is approved by the U.S. Food and Drug Administration as an immunomodulatory drug for skin complications in patients with leprosy. It is also being tested in phase 2 and 3 trials for the treatment of multiple myeloma and myelodysplastic syndromes (MDS). However, the drug is most often used off-label, particularly in cancer patients.

The anticoagulant warfarin's narrow therapeutic range increases the potential of dangerous interactions when co-administered with other agents. Therefore, a small double-blind, randomized crossover study in 18 healthy male patients examined thalidomide's effect on warfarin concentrations in the body.

Inclusion criteria required participants to agree to use double barrier protection if engaging in sexual activity, said Dr. Wu.

Participants received once daily 200 mg of thalidomide or placebo for 9 days with a single 25 mg dose of warfarin on day 4.

The researchers analyzed blood samples for plasma warfarin and thalidomide levels. Vital signs, 12-lead electrocardiogram, hematology, urinalysis and adverse events were monitored as well.

Neither drug affected the pharmacokinetics or pharmacodynamics of the other, Dr. Wu said.

No serious adverse events were reported. Most adverse events were mild in severity with a few moderate gastrointestinal effects, although two participants dropped out due to adverse events. Commonly reported adverse events following thalidomide administration included somnolence, headache, dizziness, constipation, nausea, vomiting and dyspepsia.

Dr. Wu's team concluded that thalidomide was safe in healthy males with or without co-administration of warfarin.

[Presentation title: Thalomid(R) (Thalidomide) Does Not Affect the Pharmacokinetics and Pharmacodynamics of Warfarin in Healthy Subjects. Abstract 41]

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