FDA finds 'final link' in heparin case

For the first time, the FDA has conclusively tied patients' deaths to the contaminant found in Baxter's heparin blood thinner. Of 10 deaths reported from anaphylactic shock, three of them were traced to lot numbers of the drug that tested positive for oversulfated chondroitin sulfate. (The lot numbers of the other seven weren't known.) "We have what looks like cause and effect in some patients," Dr. Janet Woodcock, CDER chief, told the Chicago Tribune. "This is one of the final links in the chain."

As you know, Baxter recalled its heparin products in February after a spike in severe allergic reactions to the drug. The investigation led to suppliers in China, which, some officials said, may have contaminated raw heparin deliberately to save money. In the process, the probe raised questions about just how close an eye drugmakers keep on their foreign supply chains; Baxter admitted that it didn't know much about the ultimate source of the ingredient it bought from Scientific Protein Laboratories, which operated a plant in China. All told, FDA counted more than reports of more than 90 deaths and 1,000 adverse reactions to heparin.

- read the story in the Tribune

Suggested Articles

Johnson & Johnson has expanded its COVID-19 vaccine production pact with CDMO Catalent to include work at the manufacturer's Anagni, Italy site.

German vaccine maker CureVac scored an $85 million EU loan to expand manufacturing for its mRNA-based COVID-19 vaccine hopeful.

Learn how drug substance and drug product early development strategies are important for optimization and long-term success.