Contamination blamed for herbal injections in relation to deaths

(Xinhua)
Updated: 2008-10-14 22:15

BEIJING - China's drug safety watchdog on Tuesday blamed contamination for an herbal injection product suspected of causing three deaths earlier this month.

Tests on samples of "ciwujia" herbal Injection showed the product had been "tainted by bacteria," the Ministry of Health and the State Food and Drug Administration (SFDA) said in a joint statement issued on Tuesday.

They didn't specify the bacteria and only said they were investigating how the contamination took place.

On Monday, the SFDA ordered the producer, Wandashan Pharmaceutical Company in northeastern Heilongjiang Province, to recall all its "ciwujia" herbal injection products and report the progress on a daily basis.

Before the announcement, China had suspended distribution or medical use of the herbal injection.

By October 11, 4,547 bottles of "ciwujia" herbal injection had been either recalled or confiscated, SFDA figures showed.

The problematic medicine was from two batches produced in December, 47,930 bottles in total, which had been sold to 53 drug stores and 92 hospitals in 16 provinces, autonomous regions and municipalities, according to the SFDA.

In total, 43,383 injections had been used.

Six patients in the southwestern Yunnan Province experienced adverse reactions after receiving a ciwujia injection from the two batches, with symptoms including vomiting and going comatose. Three died in hospital on October 6. The others were described as stable, but were still under observation.

The medicine was extracted from ciwujia, a type of Siberian ginseng. The injections are often used to treat thrombosis caused by a weak liver and kidneys. It is also believed to be helpful in treating coronary heart disease, nervous exhaustion and menopausal problems.

Wandashan Pharmaceutical has more than 570 staff and has manufactured ciwujia for more than 30 years.