Baxter: No Endotoxins in Recalled Heparin

According to several news reports today, a Baxter spokeswoman claims that company scientists have excluded "common bacterial sources of contamination, such as the pertussis, botulinum, diptheria, cholera and tetanus toxins," in the recalled heparin. This information has not been confirmed by FDA sources in news reports to date. CDER director, Janet Woodcock, did indicate to news sources on Friday that the FDA is close to identifying the masquerade heparin found in the raw product from Baxter's Chinese supplier.

Afterthought/Update: It's not clear from news sources whether Baxter is claiming that the masquerade heparin (a glycosaminoglycan) is not an endotoxin, or that there are no endotoxins in the contaminated heparin. There should be some miniscule level of endotoxin in the product, but the specific level (and its relationship to a control level) has not been provided. It should be remembered that endotoxin levels in Chinese-made counterfeit gentamicin (which was responsible for similar reactions in 1995 at a Los Angeles hospital) were within USP standards but more than 10 times the level found in a comparator antibiotic.