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FDA Warns Bioniche on Sotradecol Promotions

FDA sent Bioniche Pharm a written warning notice for a series of websites promoting its varicose vein treatment Sotradecol.

In the letter, the FDA said that it reviewed two Sotradecol web pages located on the Bioniche Pharma website (www.sotradecolusa.com or “Bioniche web page”) and the AngioDynamics, Inc. website (www.angiodynamics.com/pages/products/Sotradecol.asp or “AngioDynamics web page”) as part of its routine monitoring and surveillance program.  The agency found that these two web pages were misleading because they (1) presented efficacy claims for Sotradecol but failed to communicate any information about the risks associated with the brand, (2) broadened Sotradecol’s approved use, and (3) overstated Sotradecol’s efficacy.

Specifically, the FDA said that the Bioniche and Angiodynamics web pages “entirely omit risk information for Sotradecol.”  The letter also states that these web pages made claims that “entirely avoid mention of the actual indication, which is for the treatment of a very limited subset of varicose veins, and misleadingly suggest that Sotradecol is appropriate for use in all sclerotherapy patients and procedures.  The Contraindications and Precautions sections of the product label lists numerous conditions in which Sotradecol is either inappropriate or should be used with extreme caution, and these two web pages failed to present such material limitations and thus broadened Sotradecol’s FDA-approved indication.  Third, the FDA said that a graphic contained in one of the web pages “overstates the efficacy of Sotradecol” and “fails to provide any information regarding the ranges of the results patients may achieve depending on [several] variables.”
The FDA also expressed concern over Bioniche’s “continued violative promotion of this product,” because this is not the first time the agency sent Bioniche a letter like this.
In an earlier letter dated April 14, 2006, the FDA told Bioniche Pharma to immediately cease the dissemination of violative promotional materials for Sotradecol and to respond to the agency within four days.
In the 2006 letter, the FDA said that it reviewed a product brochure for Sotradecol that was submitted by Bioniche Pharma Group and made available on the product website.  The agency found it to be misleading because it presented numerous claims about how safe and effective Sotradecol, but failed to reveal material facts, minimized the risks associated with Sotradecol treatment, broadened the indication, included unsubstantiated claims, and presented misleading graphics.

Specifically, the FDA said that the Bioniche and Angiodynamics web pages “entirely omit risk information for Sotradecol.”  The letter also states that these web pages made claims that “entirely avoid mention of the actual indication, which is for the treatment of a very limited subset of varicose veins, and misleadingly suggest that Sotradecol is appropriate for use in all sclerotherapy patients and procedures.  The Contraindications and Precautions sections of the product label lists numerous conditions in which Sotradecol is either inappropriate or should be used with extreme caution, and these two web pages failed to present such material limitations and thus broadened Sotradecol’s FDA-approved indication.  Third, the FDA said that a graphic contained in one of the web pages “overstates the efficacy of Sotradecol” and “fails to provide any information regarding the ranges of the results patients may achieve depending on [several] variables.”

The FDA also expressed concern over Bioniche’s “continued violative promotion of this product,” because this is not the first time the agency sent Bioniche a letter like this.

In an earlier letter dated April 14, 2006, the FDA told Bioniche Pharma to immediately cease the dissemination of violative promotional materials for Sotradecol and to respond to the agency within four days.

In the 2006 letter, the FDA said that it reviewed a product brochure for Sotradecol that was submitted by Bioniche Pharma Group and made available on the product website.  The agency found it to be misleading because it presented numerous claims about how safe and effective Sotradecol, but failed to reveal material facts, minimized the risks associated with Sotradecol treatment, broadened the indication, included unsubstantiated claims, and presented misleading graphics.

If you have been treated with Sotradecol on or before September 14, 2009, you may be entitled to compensation.

This notice applies to all residents of Arkansas, California, Connecticut, Florida, Kansas, Missouri, New Jersey, New Mexico, New York, Ohio, South Carolina, Vermont, Washington, and Wisconsin.  If you live in one of these states, you may be eligible for compensation if you were prescribed and purchased Sotradecol on or before September 14, 2009.