Safety Profile in Clinical Studies

Varithena® safety profile established in clinical trials1,2

Safety evaluated in 1333 patients in 12 clinical trials

  • No clinically important neurologic or visual AEs suggestive of cerebral gas embolism
    • The incidence of neurologic and visual adverse events within 1 day of treatment in the placebo-controlled studies was 2.7% in the pooled Varithena® group* and 4.0% in the placebo groups
    • Neurologic adverse events (cerebrovascular accident, migraines) have been reported in patients following administration of physician-compounded foam sclerosants
  • No anaphylaxis or life-threatening hypersensitivity reactions reportedSevere allergic reactions have been reported following administration of liquid polidocanol, including anaphylactic reactions, some of them fatal. Observe patients for at least 10 minutes following injection and be prepared to treat anaphylaxis appropriately
  • No pulmonary emboli reported. Proximal symptomatic venous thrombi occurred in <1% of patients treated with Varithena®. Approximately half (49%) of patients with thrombi received treatment with anticoagulantsVarithena® can cause venous thrombosis. Follow administration instructions closely and monitor for signs of venous thrombosis after treatment
  • Skin discoloration adverse events were reported in 1.1% of the pooled Varithena® group* and 0.7% of the placebo group in placebo-controlled studies
  • No treatment-related life-threatening serious adverse events

For more information on adverse events, see the Full Prescribing Information.

Note: Because clinical trials are conducted under controlled but widely varying conditions, adverse reaction rates observed in clinical trials of Varithena® cannot be directly compared to rates in the clinical trials of other drugs or procedures and may not reflect the rates observed in practice.

*Pooled Varithena® group includes Varithena® 0.125%, 0.5%, 1.0%, and 2.0%

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