Baxter Warned on Tisseel Sealant PromoMay 6, 2009 | Parker Waichman LLP
Baxter International has received a warning letter from the U.S. Food and Drug Administration over how it promoted its Tisseel surgical sealant, reports Reuters. The letter states that Baxter’s marketing of Tisseel were misleading, citing a brochure and other sales materials, said Reuters.
U.S. regulators warned Baxter International Inc that company marketing for Tisseel surgical sealant—a spray used during surgery to stop bleeding—were misleading, according to a letter released this week, said Reuters. The warning letter states that a presentation, brochure, and sell sheet overstated Tisseel, were either false or misleading, and made unsubstantiated “claims of superiority” over other “conventional hemostatic agents,” said the FDA letter. Reuters said that the FDA asked Baxter to immediately cease using the questionable materials as well as to provide a plan for how it will make corrections and release messages.
Baxter has been at the center of a number of other scandals, for example:
- March 2009: Advocacy group Public Citizen criticized the FDA for how it handled the most recent recall of Baxter International’s COLLEAGUE Infusion Pumps, which have had numerous safety problems in the past and were only just recalled despite that problems were known much earlier in the year.
- March 2009: The FDA announced the seventh Class I recall of COLLEAGUE infusion pumps. A Class I recall is the agency’s most serious, and is issued when a device poses a risk of serious injury or patient death if it malfunctions.
- January 2009: Baxter sent an Urgent Device Correction letter to its customers regarding its COLLEAGUE infusion pumps following six serious injuries. Three of 19 deaths attributed to Baxter Infusion Pumps were linked to the problems cited in the letter.
- September 2008: In response to reports of serious adverse events associated with them, the FDA announced that companies which market unapproved ophthalmic balanced salt solutions (BSS) and unapproved topical drug products containing papain must stop manufacturing and marketing these products or risk enforcement action. Baxter was one of the drug makers selling unapproved versions of BSS.
- March 2008: The FDA confirmed it found oversulfated chondroitin sulfate in samples of the active ingredient used in Baxter Heparin. The FDA said the chondroitin sulfate was molecularly changed to mimic Heparin’s blood-clotting properties. That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories. Chondroitin sulfate costs a fraction of the ingredient usually used in Heparin, and producers may have used it in an attempt to cut costs.
- January 2008: Baxter International recalled nearly all its Heparin injections in the U.S. after some patients experienced extreme, in some cases fatal, allergic reactions, after being administered the products.