Safety of intramuscular influenza immunization among patients receiving long-term warfarin anticoagulation therapy

Background: The effect of influenza vaccine on the prothrombin time (PT) among patients taking warfarin is unclear, as previous studies have shown conflicting results and the clinical significance of such a purported effect is uncertain. Moreover, to our knowledge, there are no data confirming the safety of intramuscular injections in patients receiving anticoagulant therapy with regard to possible local hematoma formation. We measured the effect of influenza vaccine on the PT among patients receiving long-term warfarin sodium therapy and evaluated the safety of intramuscular injections among them. Methods: Forty-one adult patients who were receiving anticoagulant therapy were given 0.5 mL of influenza vaccine intramuscularly. Prothrombin time and arm girth were measured at baseline and on days 3, 7, and 14 after immunization. Local pain and tenderness were assessed on a five-point scale. Patients and study nurses were blinded to all prior measurements. Differences between baseline PT and that at each subsequent visit and the maximal change in arm circumference from baseline were calculated for each patient. Mean, range, and 95% confidence intervals were calculated for the entire group. Results: There was no statistically significant change in PT between baseline and days 3, 7, and 14 after vaccination, and no significant change in arm circumference was noted. There were no clinically detectable local complications after intramuscular injection and no major or minor bleeding episodes after influenza vaccination. Conclusions: Influenza vaccine has no significant effect on the PT in patients who are being treated with warfarin. influenza vaccine can be administered intramuscularly to patients who are receiving anticoagulant therapy without the risk of local bleeding complications. (Arch Intern Med. 1995;155:1529-1531)