(Xinhua)
Updated: 2008-05-06 23:48

BEIJING  -- Chinese experts said on Tuesday that no direct link between 81 deaths in the US and a substance in blood thinner has been proven.

Jin Shaohong, deputy director of China's National Institute for the Control of Pharmaceutical and Biological Products, told a press conference that according to a current heparin-related adverse event study, "the direct causal relationship between the heparin substitute (hypersulphated chondroitin sulphate) and the clinical cases of deaths cannot yet be confirmed."

Jin said at present, apart from the US and Germany, more than 10 countries using heparin products containing "heparin-like substance" had not reported any cases of adverse reactions.

"US experts also analyzed that the concentrated heparin adverse events which occurred in the US had a certain relationship with the large dose of clinical use and quick injecting speed," he said.

The US-based Covidien Pharmaceutical Co. and B. Braun Pharmaceutical Co. also bought the raw heparin containing the substance from the US-based Scientific Protein Laboratories (SPL) for injection production, but no serious adverse reactions occurred, Jin said. The SPL owns a Chinese factory in Changzhou that supplies ingredients for heparin.

He said that serious adverse reactions also occurred in some batches of heparin injection products with raw materials containing no heparin-like substance.

Jin said adverse reaction cases in the US were all reported by patients themselves via a spontaneous reporting system, lacking doctors' confirmation.

He said further analysis was needed to decide the relationship between heparin-like substance and the deaths.

The latest development comes after China's Ministry of Health received reports from the State Food and Drug Administration that heparin products had caused serious reactions and even deaths in the United States. Raw heparin produced and exported by some companies in China was involved.

On April 21, the US Food and Drug Administration reported that 81 deaths were related to the use of heparin products.