The U.S. Food and Drug Administration said Thursday that it
had received a report from German health authorities involving about 100 cases
of allergic reactions possibly linked to heparin sold by a German company. No fatalities
were reported though.
This is a strange thing since the heparin made by the German
company, Rotexmedica, of Trittau, Germany, comes from a different supplier than
the one used by Baxter, which came from Scientific Protein Laboratories, in
Changzhou, China.
Following the German report, the FDA urged all U.S. suppliers
of heparin to start using sophisticated tests to see if their products are free
of a contaminant that is leading suspect in the allergic reactions linked to Baxter’s
medication.
"This contaminant is present in significant quantities in some of the active
pharmaceutical ingredients, accounting for approximately 5 to 20 percent of the
substance tested," Dr. Janet Woodcock, acting director of the FDA’s Center
for Drug Evaluation and Research said Wednesday. In addition, this contaminant
seems impossible to be detected with standard drug-quality tests because it
mimics heparin.
Heparin, made from ingredients extracted from pig intestines, is used to
prevent blood clots in millions of people with heart conditions, kidney disease
and in surgery. The adverse reactions seen in Germany
happened in a dialysis center and included severe allergic reactions and shock,
U.S.
health officials said.
“German authorities have identified a cluster of events in a
dialysis center. They also have a cluster of similar reports from doctors. The heparin
active ingredient in that [German] product is not obtained from the same source
as the Baxter product,” Dr. Woodcock said during a Thursday afternoon conference,
according to Forbes.
Following the German report, Scientific Protein Laboratories
issued a statement Thursday saying the German situation “demonstrates that the
heparin problem is not within Changzhou SPL’s or Baxter’s manufacturing
facilities, but our investigation onto the root cause of the problem will
continue.”
On Wednesday, Dr. Woodcock said that a possibly counterfeit
ingredient had been found in certain batches of heparin linked to at least 19
deaths in the U.S.
and more than 700 severe allergic reactions since the end of December.
Last month, Baxter recalled nine lots of the heparin after
receiving hundreds of reports of allergic reactions possibly linked to heparin,
as well as reports of four deaths. Last month, the company recalled all remaining
heparin products