FDA Never Inspected Chinese Plant Making Baxter’s Heparin
A Chinese manufacturing plant that was never inspected by the U.S. Food and Drug Administration could be the source of a potentially deadly allergic reaction experienced by hundreds of U.S. patients infused with Baxter International Inc.’s blood thinner heparin.
The FDA said it was still trying to determine why the Chinese plant under investigation was not inspected before it was allowed to ship the active ingredient in heparin to a Baxter-owned plant in Cherry Hill, N.J., where the drug is finished.
The product has been shipped for several years by a U.S. supplier near Shanghai that owns the plant. Neither Deerfield-based Baxter nor the FDA would name the U.S. supplier or the exact location of its plant.
“While no inspection of the facility has been conducted to date, preparations are being made to perform an inspection as soon as possible,” the FDA said in a statement to the Tribune. “We have already requested expedited access to the facility, facilitated through a recently assigned agreement with the Chinese State Food and Drug Administration.”
The active pharmaceutical ingredient in heparin is an enzyme in pig intestines. Baxter supplies about half of the U.S. market for heparin, which is used in heart surgery, kidney dialysis and other procedures.
It remains unclear what the cause of the allergic reactions is or whether the active ingredient or the Chinese manufacturing plant is involved, but the Chinese factory has come under suspicion.
“We are aggressively investigating the cause of the increase in adverse reactions,” Baxter spokeswoman Erin Gardiner said.
China is the world’s largest supplier of active pharmaceutical ingredients, but export safety has become an increasing problem, with reports of Chinese-made toys and food being linked to contaminants.
The FDA conducted only 11 inspections of Chinese facilities in 2007 out of more than 170 worldwide, and the number of inspections of Chinese plants actually dipped from a peak of 18 in 2004, Sen. Charles Grassley (R-Iowa) said in a Feb. 1 letter to the FDA.
Baxter said it inspected the U.S. supplier’s China facility less than six months ago and plans to inspect it and one of the U.S. supplier’s U.S. facilities “as part of our overall investigation to determine the cause of the recent increase in adverse reactions,” Gardiner said. Baxter said it tests its active ingredients before finishing the product.
The Wall Street Journal’s Web site first reported the China connection Wednesday.
The FDA earlier this week braced U.S. health facilities for potential shortages of the popular blood thinner after Baxter stopped making certain heparin vials over concerns of mysterious allergic reactions.
The reactions, believed to be limited to “initial loading” dosages administered before in-center dialysis treatment or heart surgery, have included nausea and difficulty breathing and can lead to death, the FDA has said.
