Risks of Using Compounded Drugs
Sotradecol® (sodium tetradecyl sulfate injection) is indicated in the treatment of small uncomplicated varicose veins of the lower extremities that show simple dilation with competent valves. The benefit-to-risk ratio should be considered in selected patients who are great surgical risks.
Compounding pharmacies exist to make drugs to fit the unique needs of a patient. It is done for a variety of reasons, such as to change how the medication is ingested or if a patient is allergic to a certain ingredient in an approved drug, or to get an exact dosage that is not otherwise available. The FDA has found that pharmacies are in violation of the applicable guidelines when they are: “Compounding drug products that are commercially available in the marketplace or that are essentially copies of commercially available FDA-approved drug products.”
Since its clearance for use in 2004 it has become illegal for pharmacies to compound Sotradecol except in very limited quantities appropriate for individual patient prescription (for example, that may have an allergic reaction to an ingredient in the FDA-approved product).
Compounding pharmacies have varying standards; the safety and effectiveness of compounded medications are not verified by the FDA. An analysis of sodium tetradecyl sulfate from several US compounding pharmacies showed variability in concentration and the presence of potentially harmful contaminants1,2. This could increase the risk of adverse reactions and sub-optimal outcomes for patients.
FDA approved Sotradecol is available in the US market. Bioniche Pharma USA manufactures Sotradecol in an approved facility and it is sold by AngioDynamics, Inc.
Visit the FDA’s website for more information about compounding pharmacies: http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074398.htm
References
- Almeida, Jose I. FDA-Approved Sodium Tetradecyl Sulfate (STS) versus Compounded STS for Venous Sclerotherapy. Dermatol Surg 2007; 33:1037-1044.
- 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.
