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Baxter Confirms Possible Irregularities in Heparin

The drug maker and the FDA say it's too early to tell whether a plant in China is at fault. Some see an issue with U.S. oversight.
By Don Lee and Ricardo Alonso-Zaldivar, Los Angeles Times Staff Writers
2:05 PM PST, February 14, 2008

WASHINGTON — Scientific testing has found possible irregularities in some samples of a blood thinner ingredient linked to several deaths and hundreds of life-threatening reactions, part of a broadening international investigation, a company spokeswoman said today.

Baxter Healthcare Corp. said advanced testing had found "trace differences" in some lots of the blood thinner heparin, including quantities in which the active ingredient was produced at a supplier's plant in China, spokeswoman Erin Gardiner said.

Baxter and the Food and Drug Administration said it was too early to say whether the problems were caused by the ingredient made in China. But the disclosure is likely to add to consumer worries about goods from China after product safety scares in the past year involving Chinese-made pet food ingredients and toys. The disclosure also raised questions about FDA oversight, since the agency has never inspected the plant in China.

Several leading lawmakers in Congress said the case underscored a gaping hole in the FDA's inspection program: Although as much as 80% of the bulk drug ingredients used by U.S. manufacturers are shipped from abroad, the FDA inspects only about 7% of foreign establishments in a given year. Many have never been inspected.

Baxter emphasized that the investigation was continuing and that no conclusions had been reached.

"Baxter has detected differences between lots [of the active ingredient] but it's unclear what the impact of these differences is," Gardiner said. "They are not necessarily the root cause of the increase in adverse reactions, but they are certainly a central part of our investigation."

Some of the samples that were found to have differences "are definitely from China," she added. Earlier testing before the drug was shipped to hospitals and dialysis centers fully complied with industry and regulatory requirements, but the tests failed to detect any possible problems, Gardiner said.

Baxter announced Monday that it had suspended manufacturing of multiple-dose vials of heparin after receiving reports of 350 bad reactions, including four deaths. The drug is used to prevent the formation of dangerous blood clots during complex surgical procedures.

Heparin is a naturally occurring substance extracted from pig intestines and cow lungs. Some independent experts said contamination could have occurred at any point in the production process, from a problem with raw materials to the wrong kind of solvent being used to clean equipment.

Consumer advocates today urged a recall, but the FDA said that could do more harm than good by creating an acute shortage, since Deerfield, Ill-based Baxter accounts for about 50% of the market.

Also today, Baxter identified the supplier of the heparin as Scientific Protein Laboratories of Waunakee, Wis. A company official did not immediately return phone calls, but the firm's website says it maintains manufacturing facilities in Waunakee and Changzhou, China, about two hours' drive west of Shanghai.

Baxter said it inspected both plants last year and found no problems. FDA spokeswoman Karen Riley said the agency was planning to send inspectors to the plants in China and Wisconsin.

Industry sources in China identified the producer as a joint venture between Techpool Bio-Pharma Co. in Guangzhou and the Wisconsin-based SPL. A representative at the joint-venture plant's quality-control department confirmed that it made the ingredient for Baxter and that its production was under scrutiny by U.S. regulators.

"We are taking initiative to cooperate" with the FDA and Baxter, said the representative, who declined to give his name. "We put great emphasis on the investigation. After all, it involves people's lives."

He said the company was expecting FDA inspectors to arrive soon, but he declined to comment further. At the moment, he said, the plant was not producing heparin components.

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