Heparin Investigation Uncovers Chinese Link

Scott Kappes

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A probe into the cause behind 350 bad reactions to the blood-thinner Heparin discovered that most of the active ingredient used in Heparin is produced at a Chinese facility. This information casts new doubt on the safety of the growing percentage of Chinese-based pharmaceutical plants. About 40 percent of the bad reactions were classified as serious, including four possible deaths. The cause of the reactions has not been determined, but the company has temporarily suspended manufacturing operations. Some experts believe that the active ingredient could have been tainted during the manufacturing process, as the ingredient is derived from pig intestines.

The company said that it has been making the heparin active ingredient at the Chinese facility since 2004, and that it "engages in the same testing and quality-control procedures as U.S. facilities that produce bulk heparin" and meet FDA standards.

The Chinese factory is expected to be visited by FDA authorities on Monday for the first time. The FDA simply does not have the means to fly inspectors around the world constantly to check up on manufacturing sites in other countries. Most inspections must be done in a condensed trip where an inspector will visit several sites over a given period. This often allows foreign manufacturing sites to have a heads up on when an inspector will be on site. The commissioner of the FDA, Andrew von Eschenbach, has expressed interest in stationing FDA inspectors in other sectors of the world, including China; however, this will require the acceptance of a formal agreement by the host nation, which could be somewhat problematic in the case of China.

The State Department is currently working on a resolution with Chinese officials on behalf of the FDA and the US government.