FDA flub tied to heparin scare

FDA flub tied to heparin scare
By Allison M. Heinrichs
TRIBUNE-REVIEW
Tuesday, February 19, 2008

A name mix-up by American drug inspectors allowed a Chinese factory to supply the United States with a widely used blood thinner linked to life-threatening allergic reactions in Pennsylvania and at least 11 states, federal Food and Drug Administration officials said Monday.

U.S. inspectors plan to investigate Changzhou Scientific Protein Laboratories, which supplied ingredients for injectable heparin manufactured by Illinois-based Baxter Healthcare Corp. The company stopped manufacturing the drug last week after it was blamed for hundreds of severe allergic reactions, mostly in dialysis patients.

The FDA does not know the cause of the allergic reactions -- which include severe nausea, difficulty breathing and very low blood pressure -- and is not sure if Changzhou SPL is the source of the problem.

"To date, this is an isolated situation," said Joseph Famulare, deputy director at FDA's Center for Drug Evaluation and Research. "The wrong firm was put into the database, therefore this one was not evaluated or scheduled for inspection."

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Changzhou SPL was confused with another company that had recently passed inspection, Famulare said. Therefore, the FDA did not inspect Changzhou SPL before approving Baxter Healthcare's application to use pharmaceutical ingredients from the company.

The FDA would not reveal the name of the company it confused with Changzhou SPL, but a spokeswoman said it is "extremely similar."

"All of us are really concerned about this situation," said Dr. Philip F. Caushaj, chief of surgery at The Western Pennsylvania Hospital in Bloomfield. He said hospital officials are discussing heparin alternatives in case of a shortage.

"If heparin were no longer immediately available to us, this would really have serious national consequences, particularly to dialysis patients who need heparin as part of their therapy," he said. "All of the hospitals in the area are going to have to come up with alternative strategies to conserve heparin and come up with alternative medications that we can use."

Dr. George Gabriel, a cardiologist at Allegheny General Hospital, North Side, said he is unaware of any allergic reactions to heparin at the hospital and is monitoring patients who receive it.

"Heparin is used for just about any adverse event involving a heart condition," Gabriel said. "It's the main treatment to prevent further blood clotting, so we use it very frequently."

In the past two months, Baxter Healthcare has received 350 reports of adverse events in patients injected with heparin, including four deaths. Heparin produced by Baxter is not being removed from pharmacy shelves because it "is a medically necessary product with some uses for which there are no well-established substitutes," according to the FDA.

When possible, health care providers should use an alternative source of heparin, which also is manufactured by APP Pharmaceuticals. When only Baxter heparin is available, the FDA says doctors should use the smallest dose possible, inject it slowly and monitor patients for allergic reactions.

Dialysis Clinic, Inc. -- which is based in Nashville and has 27 clinics in Pennsylvania, the majority in the Pittsburgh area -- shelved all of its heparin from Baxter and has been using heparin from APP, said James Long, an administrator for DCI in Western Pennsylvania.

A University of Pittsburgh Medical Center spokeswoman said in an e-mail that the health system would not comment.

Allison M. Heinrichs can be reached at aheinrichs@tribweb.com or 412-380-5607.

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