The contaminant, a large complex molecule chemically  similar to heparin, was detected in samples from a Chinese and  a U.S. plant, both owned by Baxter’s supplier, Wisconsin-based  Scientific Protein Laboratories LLC (SPL). “At this point we don’t know how the heparin-like compound  got into the active pharmaceutical ingredient,” Food and Drug  Administration Deputy Commissioner Janet Woodcock told  reporters on a conference call. “We don’t yet have a direct  causal link between the contaminant and the adverse events.”    Nineteen deaths have been reported in patients taking a  version of heparin that appear related to the drug, though it  is unknown if all of those patients were on Baxter’s heparin or  another product. The other major U.S. heparin supplier, APP Pharmaceuticals  Inc, ramped up production to avoid a drug shortage after Baxter  recalled most of its heparin products last week. Tests on APP’s heparin have not turned up any  contamination, Woodcock said. The FDA’s foreign inspection process has been criticized  for years as inadequate and those complaints were stoked when  FDA officials acknowledged recently the agency never inspected  the Chinese plant in question because of confusion over the  company’s Chinese name. FDA has not yet sifted through the 785 total adverse event  reports in heparin patients to determine which are  drug-related, Woodcock said. She cautioned that increased attention to the problem has  led to an influx of side-effect reporting and that may not be  related to the drug. Heparin is derived from pig intestines and is used in  dialysis and heart procedures, among other surgeries, to avoid  blood clots. Last week, the FDA said it found “objectionable conditions”  at the plant. Facility owner Scientific Protein Labs in a  statement said the contaminant theory is “speculation at this  point” and that it is working with the FDA to determine the  cause of the problems. FDA officials also don’t know whether the contaminant was  added intentionally or if it occurred as part of a natural  biological process. “We still don’t know whether this inadvertently got into  the supply or whether it was actually added” deliberately,  Woodcock said. Severe reactions such as anaphylaxis and low blood pressure  are signs of dangerous allergic reactions related to heparin  use. Earlier on Wednesday, Baxter, which has recalled most of  its heparin blood thinning products, said it narrowed down  possibilities for the root causes. Baxter ruled out its Cherry Hill, New Jersey, facility,  where the drug is manufactured in a later step in the process,  as a source of the problem.
FDA says contaminant in some Baxter heparin.