What is Varithena and How Does It Work?
Varithena (polidocanol injectable foam) is a prescription medication used to treat varicose veins, specifically incompetent great saphenous veins (GSV) and related veins in the leg's GSV system [1.3.5]. It is a type of sclerosing agent, which works by damaging the endothelium, the cell lining of blood vessels [1.5.6]. The foam is injected directly into the malfunctioning vein, which displaces the blood. This causes the vein to collapse, and blood flow is redirected to healthier veins nearby [1.4.6]. The treated vein is then gradually absorbed by the body. Varithena is considered a non-thermal, non-tumescent procedure, meaning it does not use heat or large volumes of numbing anesthetic fluid, which distinguishes it from treatments like laser or radiofrequency ablation [1.4.6]. The procedure is minimally invasive and typically takes less than an hour, often requiring only one or two needle sticks per session [1.5.3].
Common Patient Complaints and Side Effects
The most frequently reported complaints associated with Varithena are typically mild and localized to the treatment area. Clinical trial data shows that these are the most common adverse events [1.3.1, 1.2.4]:
- Pain and Discomfort: Leg pain or discomfort in the treated extremity is a very common side effect, reported in up to 16.8% of patients in one study [1.2.4]. However, about 80% of these pain events resolved within one week [1.3.3].
- Injection Site Reactions: A large percentage of complaints relate directly to the injection site. These include:
- Bruising (contusion) or hematoma (a collection of blood under the skin), which can occur in up to 42% of patients [1.2.2, 1.2.4].
- Pain, tenderness, itching, warmth, or swelling at the injection site are also common [1.2.2, 1.2.3].
- Retained Coagulum: This refers to trapped, clotted blood within the treated vein, which was reported as 'infusion site thrombosis' in 16.1% of patients in clinical trials [1.2.4].
Other less frequent but still common side effects include numbness or tingling, headache, and dizziness [1.2.4]. Some patients may also notice temporary skin discoloration or increased hair growth in the treated area [1.2.3, 1.2.2].
Serious Risks and Potential Complications
While most side effects are mild, there are more serious complaints and risks associated with Varithena. The most significant is the risk of venous thrombosis (blood clots).
- Deep Vein Thrombosis (DVT): This is a serious condition where a blood clot forms in a deep vein, usually in the leg. In clinical trials, DVT occurred in 4.7% of patients treated with Varithena 1% [1.2.4]. Patients with reduced mobility, a history of blood clots, recent major surgery, or pregnancy are at an increased risk [1.7.6]. Symptoms include pain, swelling, warmth, or redness in the leg [1.2.5].
- Pulmonary Embolism (PE): A rare but life-threatening risk is that a piece of a blood clot can break off and travel to the lungs. Symptoms include trouble breathing and chest pain [1.8.6, 1.7.2].
- Anaphylaxis: Severe allergic reactions to polidocanol have been reported, some of which were fatal [1.3.3]. For this reason, patients must be observed for at least 10 minutes after the injection [1.5.6]. Signs of an allergic reaction include hives, difficulty breathing, and swelling of the face, lips, or tongue [1.2.5].
- Tissue Ischemia and Necrosis: If Varithena is accidentally injected into an artery or leaks out of the vein (extravasation), it can cause severe tissue damage, including skin necrosis (death of tissue) [1.3.3, 1.2.2]. This can result in permanent skin depression or discoloration [1.2.2].
- Nerve Injury: Though uncommon (0.1% to 1%), nerve injury is a possible complication that can lead to numbness, tingling, or burning feelings [1.2.2].
Comparison of Varithena to Other Vein Treatments
Patients considering treatment for varicose veins have several options. The choice depends on the size and location of the veins, as well as patient and provider preference [1.4.1].
| Feature | Varithena (Foam Sclerotherapy) | Endovenous Laser/Radiofrequency Ablation (EVLA/RFA) | VenaSeal™ | Traditional Sclerotherapy |
|---|---|---|---|---|
| Mechanism | Chemical foam collapses vein [1.4.6]. | Thermal energy (heat) from laser or radiofrequency closes the vein. | Medical adhesive (glue) seals the vein shut [1.4.5]. | Liquid chemical solution irritates and closes smaller veins [1.4.1]. |
| Best For | Large, twisting, or deep veins; GSV system [1.4.6]. | Straight, large veins like the great saphenous vein [1.4.1]. | Straight, large veins like the great saphenous vein. | Smaller spider veins and reticular veins [1.4.1]. |
| Anesthesia | Local anesthetic at injection site is minimal or not required [1.4.6]. | Requires tumescent anesthesia (large volume of dilute local anesthetic) along the vein. | No tumescent anesthesia needed [1.4.4]. | Typically none needed. |
| Common Complaints | Bruising, leg pain/discomfort, retained coagulum [1.3.1]. | Bruising, pain, risk of skin burns or nerve injury. | Mild inflammation, phlebitis. | Stinging at injection site, bruising, skin discoloration. |
| Recovery | Minimal downtime; compression stockings required [1.2.3]. | Minimal downtime; compression stockings required. | Often quickest recovery; compression may not be necessary. | Minimal downtime; compression often recommended. |
Who Should Not Use Varithena?
Varithena is contraindicated in certain patients. These include individuals with [1.5.4, 1.5.2, 1.3.5]:
- A known allergy to polidocanol.
- Active acute thromboembolic disease, such as deep vein thrombosis (DVT) or pulmonary embolism (PE).
Caution is also advised for patients with a history of blood clots, significantly reduced mobility, recent major surgery or hospitalization, or those who are pregnant [1.7.6].
Conclusion: A Balance of Efficacy and Risk
Varithena is an effective, minimally invasive treatment for many people suffering from varicose veins, improving both symptoms and appearance [1.5.3]. However, patients must be aware of the potential complaints and side effects. The most common issues, such as injection site pain and bruising, are generally temporary and resolve within a week [1.3.3]. The more serious risk of blood clots, while less common, requires careful consideration and monitoring, particularly for those with pre-existing risk factors [1.7.6]. A thorough discussion with a qualified healthcare provider who is experienced in venous procedures is essential to weigh the benefits against the potential complaints and determine if Varithena is the appropriate treatment option [1.3.1].
Authoritative Link: Boston Scientific - Varithena Patient Information
