"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
Local reactions consisting of pain, urticaria or ulceration may occur at the site of injection. 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. (See WARNINGS section).
Allergic reactions such as hives, asthma, hay fever and anaphylactic shock have been reported. Mild systemic reactions that have been reported include headache, nausea and vomiting. (See WARNINGS section).
At least six deaths have been reported with the use of Sotradecol® (sodium tetradecyl) . Four cases of anaphylactic shock leading to death have been reported in patients who received Sotradecol® (sodium tetradecyl) . One of these four patients reported a history of asthma, a contraindication to the administration of Sotradecol®. (See WARNINGS section).
One death has been reported in a patient who received Sotradecol® (sodium tetradecyl) and who had been receiving an an ovulatory agent. Another death (fatal pulmonary embolism) has been reported in a 36-year-old female treated with sodium tetradecyl acetate and who was not taking oral contraceptives.
Read the Sotradecol (sodium tetradecyl) Side Effects Center for a complete guide to possible side effects
No well-controlled studies have been performed on patients taking anovulatory agents. The physician must use judgment and evaluate any patient taking anti ovulatory drugs prior to initiating treatment with Sotradecol® (sodium tetradecyl) . (See ADVERSE REACTIONS section).
Last reviewed on RxList: 7/16/2008
Additional Sotradecol Information
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