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Varithena

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Varithena

Side Effects
Interactions

SIDE EFFECTS

Clinical Trials Experience

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.

A total of 1333 patients in 12 clinical trials were evaluated for safety when treated with Varithena™ at dose concentrations of 0.125%, 0.5%, 1.0% or 2.0%, including 437 patients treated with Varithena™ in placebo-controlled clinical trials.

Adverse reactions occurring in 3% more patients receiving Varithena™ 1% than receiving placebo are shown in Table 1.

Table 1: Treatment-emergent adverse reactions (3% more on Varithena™ 1% than on placebo) through Week 8 (n=588)

Adverse Reaction Placebo
(N=151)
Varithena™ 1.0%
(N=149)
Pooleda Varithena™
(N=437)
Pain in extremity 14 (9.3) 25 (16.8) 65 (14.9)
Infusion site thrombosisb 0 24 (16.1) 46 (10.5)
Contusion/injection site hematoma 9 (6.0) 23 (15.4) 38 (8.7)
Limb discomfort 5 (3.3) 18 (12.1) 32 (7.3)
Tenderness/injection site pain 5 (3.3) 16 (10.7) 30 (6.9)
Venous thrombosis limbc 0 12 (8.1) 24 (5.5)
Thrombophlebitis superficial 2 (1.3) 8 (5.4) 40 (9.2)
Deep vein thrombosis 0 7 (4.7) 10 (2.3)
aIncludes Varithena™ 0.125%, 0.5%, 1.0%, and 2.0% from the placebo-controlled trials.
bRetained coagulum.
cCommon femoral vein thrombus extension (non-occlusive thrombi starting in the superficial vein and extending into the common femoral vein).

In Varithena™-treated patients, 80% of pain events in the treated extremity resolved within 1 week.

In the 1333 patients treated with Varithena™, the following venous thrombus adverse events occurred: common femoral vein thrombus extension (2.9%), proximal deep vein thrombosis (DVT) (1.7%), distal DVT (1.1%), isolated gastrocnemius and soleal vein thrombosis (1.4%).

Proximal symptomatic venous thrombi occurred in < 1% of patients treated with Varithena™. Approximately half (49%)of patients with thrombi received treatment with anticoagulants.

Since Varithena™ induces thrombosis in the treated superficial veins, D-dimer is commonly elevated post-treatment and is not useful diagnostically to assess patients for venous thrombus following treatment with Varithena™.

Neurologic adverse events (cerebrovascular accident, migraines) have been reported in patients following administration of physician compounded foam sclerosants. None of the 1333 patients in the Varithena™ trials experienced clinically important neurological or visual adverse events 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.

Skin discoloration adverse events were reported in 1.1% of the pooled Varithena™ group and 0.7% of the placebo group in the placebo-controlled studies.

Read the Varithena (polidocanol injectable foam) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

No specific drug interaction studies have been performed. There are no known drug interactions with Varithena™.

Last reviewed on RxList: 7/17/2014
This monograph has been modified to include the generic and brand name in many instances.

Side Effects
Interactions
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