Recently, the Food and Drug Administration’s (FDA) Division of Drug, Marketing, Advertising, and Communications (DDMAC) issued a Warning Letter to Bioniche Pharma USA objecting to several web pages that promoted Sotradecol® (sodium tetradecyl sulfate injection). Specifically, these web pages failed to convey any information regarding the risks associated with Sotradecol®, claims on the web pages broadened the approved indications beyond the treatment of small uncomplicated varicose veins of the lower extremities that show simple dilation with competent valves, and the web page overstated the efficacy of Sotradecol®.
Bioniche Pharma USA would like to take the opportunity to provide important corrective information about the safe and appropriate use of Sotradecol®.
Indication and Efficacy:
The web pages misleadingly suggested that Sotradecol® is effective in all sclerotherapy patients and procedures. However, Sotradecol® 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.
Bioniche Pharma’s past use of photographs and general claims regarding Sotradecol’s® use in the sclerotherapy market should not be interpreted as claims that Sotradecol® may be used in any sclerotherapy patient or that patients may achieve varicose-free legs as a result of treatment with Sotradecol®.
Risk Information:
The web pages did not disclose any important risk information about Sotradecol®. The information is presented below:
Contraindications:
Sotradecol® is contraindicated in:
- patients with previous hypersensitivity reactions to the drug;
- acute superficial thrombophlebitis;
- valvular or deep vein incompetence;
- huge superficial veins with wide open communications to deeper veins;
- phlebitis migrans;
- acute cellulites;
- allergic conditions;
- acute infections;
- varicosities caused by abdominal and pelvic tumors unless the tumor has been removed;
- bedridden patients;
- such uncontrolled systemic diseases as diabetes, toxic hyperthyroidism, tuberculosis, asthma, neoplasm, sepsis, blood dyscrasias and acute respiratory or skin diseases.
Warnings and Precautions:
Sotradecol® should only be administered by a healthcare professional experienced in venous anatomy and the diagnosis and treatment of conditions affecting the venous system and familiar with proper injections technique. To avoid severe adverse local effects, including tissue necrosis, following extravasation, physicians must use extreme care in intravenous needle placement and use the minimal effective volume at each injection site.
Emergency resuscitation equipment should be immediately available. Allergic reactions including fatal anaphylaxis, have been reported. As a precaution against anaphylactic shock, 0.5 mL of Sotradecol® should be injected into a varicosity, followed by several hours of observation before administration of a second or larger dose. The physician should be prepared to treat anaphylaxis appropriately.
At least six deaths have been reported with the use of Sotradecol®. Four cases of anaphylactic shock leading to death have been reported in patients who received Sotradecol®. One of these four patients reported a history of asthma, a contraindication to the administration of Sotradecol®.
One death has been reported in a patient who received Sotradecol® and who had been receiving an antiovulatory agent. Another death (fatal pulmonary embolism) has been reported in 36-year-old female treated with sodium tetradecyl acetate which was not taking oral contraceptives.
Venous sclerotherapy should not be undertaken if tests (Trendelenberg or Perthers), and angiography show significant valvular or deep venous incompetence because of the danger of thrombosis extension into the deep venous system. Physicians should conduct preinjection evaluation for valvular competency and deep venous potency must be determined by angiography or noninvasive testing such as duplex ultrasound. Physicians should administer slow injections with a small amount (not over 2 mL) of the preparation into the varicosity.
Deep vein thrombosis and pulmonary embolism have been reported following sclerotherapy treatment of superficial varicosities. Patients should have post-treatment follow-up of sufficient duration to assess for the development of deep vein thrombosis. Embolism may occur as long as four weeks after injection of Sotradecol®. Adequate post-treatment compression may decrease the incidence of deep vein thrombosis.
Extreme caution must be exercised in the presence of underlying arterial disease such as marked peripheral arteriocsclerosis or thromboangiitis obliterans (Buerger’s Disease).
Adverse Reactions with Sotradecol®
The following adverse reactions have been reported with the use of Sotradecol®
- Local reactions (pain, urticaria or ulceration) may occur at the site of injections.
- A permanent discoloration may remain along the path of the sclerosed vein segment.
- Sloughing and necrosis of tissue may occur following extravasation of the drug.
- Allergic reactions (hives, asthma, hayfever and anaphylactic shock).
- Mild systemic reactions including headache, nausea and vomiting.
For further information please refer to full prescribing information at the following link here. If you have any questions about this letter or about the use of Sotradecol® please contact Rhonda Noll, Sr. Director of Regulatory Affairs at 1-877-769-6200.
