How Sotradecol Works
Sotradecol® (Sodium Tetradecyl Sulfate Injection) was cleared for use in the United States by the Food and Drug Administration (FDA) in 2004.
Why is FDA approval important?
The FDA requires extensive testing to ensure the strength and purity of drugs and that the drug is made in an FDA-inspected manufacturing facility in accordance with good manufacturing practices. Sometimes sclerotherapy is performed with drugs made by a compounding pharmacy or with non-FDA approved drugs. Such drugs do not have to meet FDA’s standards for strength, purity and good manufacturing practices. Be sure to ask your doctor if he or she will use an FDA-approved sclerosing agent during your procedure.
What is compounding?
Pharmacies exist that specialize in using ingredients to create a compound that resembles or varies from an FDA-approved drug. While these pharmacies may use the same active ingredients found in the approved drug, they may not test the drug for purity or strength and their facilities are not inspected by the FDA for good manufacturing practices. This increases the risk that the drugs can contain impurities and vary in strength. Compounded drugs are not approved by the FDA.
Are there other FDA-cleared agents used in sclerotherapy?
Yes, there are. Two such agents are Sodium Morrhuate (Scleromate) and Polidocanol (Asclera®) (cleared for use by the FDA in 2010). Each of these agents have their particular uses, risks, precautions and general risk information. In any case where such an agent is used, the doctor should consult the full prescribing information for that product to make sure it is used appropriately.
Ask your physician if they are using an FDA approved agent.
References
Learn more about compounding by reading the following:
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http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm107836.htm
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http://www.fda.gov/downloads/ForConsumers/ConsumerUpdates/ucm107839.pdf
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http://www.fda.gov/downloads/ForConsumers/CONSUMERUPDATES/UCM143301.pdf
- Goldman, Mitchell P. Sodium Tetradecyl Sulfate for Sclerotherapy Treatment of Veins: Is Compounding Pharmacy Solution Safe? Dermatol Surg 2004; 30:1454-1456.
Important Safety Information for Sotradecol® Injection
Sotradecol is contraindicated in patients with previous hypersensitivity to the drug; inflammation or incompetence of superficial or deep veins; phlebitis migrans; acute cellulitis; allergic conditions; acute infections; varicosities caused by abdominal and pelvic tumors unless the tumor has been removed; bedridden patients; diabetes; toxic hyperthyroidism; tuberculosis; asthma; neoplasm; sepsis; blood dyscrasias; and acute respiratory or skin diseases.
Due to the risk of deep vein thrombosis, patients should be evaluated for valvular competency and deep venous patency before treatment and slow injections of a small volume (< 2 mL) should be injected. Patients should be monitored post-treatment for deep vein thrombosis and pulmonary embolism. Extreme caution must be exercised in the presence of underlying arterial disease.
Severe adverse local effects, including tissue necrosis, may occur following extravasation; therefore, take care in intravenous needle placement and use the smallest effective volume at each injection site.
Allergic reactions, including fatal anaphylaxis, have been reported. As a precaution, it is recommended that 0.5 mL of Sotradecol be injected, followed by observation for several hours before administration of a second or larger dose. Emergency resuscitation equipment should be immediately available, and the physician prepared to treat an anaphylactic reaction.
At least 6 deaths have been reported. Four of the deaths were cases of anaphylaxis; one in a patient with a history of asthma, a contraindication to Sotradecol use. Another death was in a patient who was taking an antiovulatory agent. One death (pulmonary embolism) occurred in a patient not taking an antiovulatory agent, treated with sodium tetradecyl acetate. Other adverse reactions reported include pulmonary embolism; local injection site reactions (pain, urticaria, ulceration); permanent discoloration of sclerosed vein segment; sloughing and necrosis of tissue following extravasation of the drug; allergic reactions (hives, asthma, hayfever); headache; nausea; and vomiting.
Please see full Prescribing Information for more information here.
