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Decrease in factor V activity in patients treated with azathioprine or 6-mercaptopurine.

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Azathioprine and 6-mercaptopurine can cause decreased factor V activity in patients, but this is often asymptomatic. Careful consideration of treatment discontinuation is advised for patients benefiting from these purine analog drugs.

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Area of Science:

  • Pharmacology
  • Hematology
  • Drug Safety

Background:

  • Azathioprine and 6-mercaptopurine are purine analogs used to treat various autoimmune and oncologic conditions.
  • Decreased factor V activity has been anecdotally reported in patients receiving these immunosuppressive agents.
  • This potential side effect may lead to unwarranted treatment cessation in asymptomatic individuals.

Purpose of the Study:

  • To review spontaneously reported cases of decreased factor V activity linked to azathioprine and 6-mercaptopurine.
  • To assess the clinical impact and patient care implications of this adverse event.

Main Methods:

  • Analysis of cases from the French pharmacovigilance database involving purine analogs and decreased prothrombin (PT) or factor V activity.
  • Exclusion of cases with disseminated intravascular coagulation, acute liver failure, cirrhosis, or concurrent anticoagulant therapy.

Main Results:

  • Twenty-four cases (13 azathioprine, 11 6-mercaptopurine) were identified, primarily for inflammatory bowel disease, leukemia, and autoimmune disorders.
  • Decreased PT/factor V activity occurred after a median of 10 weeks, with patients remaining asymptomatic.
  • Median PT and factor V activity levels were 51.5% and 36.4%, respectively; recovery was observed upon drug discontinuation, with recurrence upon rechallenge in some.

Conclusions:

  • The findings suggest a causative role for azathioprine and 6-mercaptopurine in asymptomatic decreases in factor V activity.
  • Given the lack of symptoms, premature treatment discontinuation should be carefully weighed in patients who benefit from these purine analogs.