FDA Orders Baxter to Stop Advertising TISSEEL as Superior to Other Hemostatic Products

    KANSAS CITY, MO, July 29, 2009 /24-7PressRelease/ -- In April 2009 the Department of Health and Human Services issued a warning letter to Baxter International, Inc., manufacturers of the surgical hemostatic drug TISSEEL, to cease misbranding of this product as superior to other hemostatic agents used to stop bleeding during surgical procedures. Additionally, Baxter has been warned to cease advertising a false level of efficacy that says TISSEEL is more effective than studies and clinical experience indicate.

This warning addressed to information being provided about the newest formulation of TISSEEL, which received FDA approval in 2006 replacing an earlier formulation approved in 1998. The newer formulation is not inferior to any other formulation approved to achieve hemostasis under the same conditions, and it is not the formulation or product that is under scrutiny. Rather, the promotional and informational materials disseminated by Baxter are misleading physicians about its quality and efficacy in violation of FDA regulations.

The warning mentioned three specific documents that were reviewed:

- Baxter's TISSEEL National Accounts Presentation
- TISSEEL General Surgery Brochure
- TISSEEL Cardiac Sell Sheet

The review found that Baxter overstated the efficacy of TISSEEL by making the statement,

"97.5% effective in achieving hemostasis in fully heparinized patients undergoing cardiopulmonary bypass,"

This statement misrepresented the actual references cited by Baxter, which actually demonstrated 88.2% efficacy in the intent-to-treat analysis and 87.8% in the per protocol analysis, neither of which come close to the 97.5% efficacy rate Baxter claims for this formulation.

Furthermore, the patient groups involved in the studies that were used as a reference for this statistic actually received the previous formulation approved in 1998, whose efficacy rate was only 92.6%, still lower than the claimed rate of 97.5%.

Baxter's TISSEEL National Accounts Presentation stated:

"In a randomized trial, TISSEEL has been found to be superior to conventional agents during redos* and resternotomies" ... "*(93.1% versus 12.6% success), (83.3% versus 10% success)"

Again, the references cited to support this fact not only contained insufficient evidence that this formulation was superior to any competing product, but, also, were dependent upon the previously mentioned references which quoted different percents associated with the 1998 formulation, not the 2006 approved formulation.

All three of Baxter's product documents described TISSEEL's superiority to competitor's agents with the following statements, which remain unsubstantiated by the references Baxter cites as evidence:

"This concentration human fibrinogen in TISSEEL [Fibrin Sealant] - over 20 times the concentration in human plasma - provides tensile strength up to 4 times higher than that of a high-salt, fibrin sealant with a non-physiologic clot structure."

"TISSEEL is the only sealant and hemostat in the U.S. containing aprotinin as an
antifibrinolytic to preclude premature clot lysis....
• ... extending the life of the clot when the natural process of fibrinolysis or
hyperfibrinolytic surgical situations (e.g., surgeries involving cardiopulmonary bypass or trauma) might otherwise threaten it."

"In pre-clinical studies, the addition of aprotinin to TISSEEL was demonstrated
to improve clot persistence"

"In vitro and in vivo studies have shown that aprotinin-free sealant degrades
significantly faster than that containing aprotinin"

"No competing fibrin sealant offers surgeons, this combination"

The warning further stated that Baxter's Presentation and Brochure included claims suggesting that the FDA approval of TISEEL was for a broader indication that it had actually intended. These documents contained the taglines

• "Seals Tissues, Stops Bleeding" (tagline)
• "Only TISSEEL does both" (tagline)
• "TISSEEL is the only fibrin sealant that can both seal tissue and stop bleeding"

The letter from Mary A. Malarkey, Director of the Office of Compliance and Biologics Quality says that these taglines imply that TISSEEL was approved by the FDA as a general hemostatic agent and sealant, which is misleading and untruthful. She demanded that Baxter submit a plan to "disseminate truthful, non-misleading, and complete corrective messages about these issues to the audiences that received the violative promotional material."

Although there is no problem with TISSEEL as a hemostatic agent, and no recall is involved with this product, the fact that physicians may be encouraged to choose it over another product based on false claims of its efficacy could have serious ramifications where another product choice might be a better one.

For more information about the consequences of this violation or to make an appointment for a personal consultation please visit the website of Schlichter, Bogard & Denton, pharmaceutical attorneys.

Source: Schlichter, Bogard & Denton
Website: http://www.druginjuryinformation.com

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