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FDA Probes Blood Thinner Drug in China

Agency to Hunt Source of Adverse Reactions From Heparin

Reviewed by Brunilda Nazario, MD on February 18, 2008
From the WebMD Archives

Feb. 18, 2008 -- U.S. inspectors will go to China this week to try to find the cause of recently reported health problems associated with a widely used blood-thinning drug, officials said Monday.

The FDA said it was sending inspectors to investigate a plant that manufactures the drug heparin for Baxter International. Reports from the agency last week linked the drug to about 350 adverse reactions, including shock and decreases in blood pressure.

The reports included four patients who died after receiving the drug.

Heparin is widely used as a blood thinner to prevent clotting during surgeries, dialysis, and other procedures. News of the adverse reactions last week added heparin to a long list of Chinese-manufactured foods, drugs, and other products causing safety concerns in the U.S.

"At this time, we don't know what is causing these adverse events," said Michael Rogers, director of the FDA's field investigations division.

Reactions were reported in patients who received heparin from multidose vials. The agency has urged doctors to stop using the vials, if possible.

Continued

FDA officials came under fire last week after reports indicated that the Changzhou SPL plant supplying heparin to the U.S. market had never been inspected by Chinese or American officials.

Charles Grassley (R-Iowa) sent a letter to FDA officials last week asking them to account for the inspection timeline that led up to the adverse reactions with heparin. The letter charged that the FDA inspected "only 11 pharmaceutical plants in China during 2007, even though hundreds if not thousands of facilities are producing active pharmaceutical ingredients (API) used in drugs sold in this country."

The number of plants inspected in China is "within the general range" of what was listed in Grassley's letter, said Joe Famulare, director of the FDA's office of compliance for drugs.

Baxter International halted heparin production last week. FDA officials said their investigation includes the company's plant in Cherry Hill, N.J., as well as distribution centers handling the drug.

"We don't know the source of the problem and we believe it would be a mistake to speculate," Rogers told reporters.

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Sources

SOURCES:

Michael Rogers, director, FDA field investigations division.

Sen. Charles E. Grassley (R-Iowa), letter to FDA, Feb. 14, 2008.

Joe Famulare, director, FDA division of compliance.

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