FDA Warns About Misleading Information on Varicose Vein Drug Sotradecol

Websites for the varicose vein drug Sotradecol contain false or misleading information that tends to overstate the product’s approved uses and efficacy while glossing over its risks, the Food and Drug Administration is warning.

The FDA sent a warning letter to Bioniche Life Sciences Inc., the maker of Sotradecol, and distributor AngioDynamics saying the agency is very concerned about the misleading information carried on web pages promoting the drug.

Bioniche was cited for the same type of marketing violations and received a similar warning letter in April 2006, the FDA said, according to a Reuters news report.

Failure to correct the violations may result in the FDA taking regulatory action against the companies, including seizure or injunction, officials warned.

Drug Linked to User Deaths, Serious Side Effects

Sotradecol is an injectable drug known chemically as sodium tetradecyl sulfate and approved in November 2004. It is used during the non-surgical removal of varicose veins (sclerotherapy), which an estimated 1.7 million patients undergo each year in the United States.

At least six deaths have been reported with the use of Sotradecol, including four cases of anaphylactic shock leading to death, the FDA said.

Common side effects of Sotradecol include pain, itching, or lesions at the injection site, as well as severe allergic reactions such as rash, hives, difficulty breathing, tightness in the chest, nausea, vomiting, and swelling of the mouth, tongue, face, and lips.

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