SHANGHAI – China has ordered a recall of two batches of acanthopanax-based injections, also know as Siberian ginseng, after reports of serious adverse reactions that caused the death of three patients in Yunan Province, China’s Ministry of Health announced Oct. 11.
According to a notice jointly issued by MOH and China’s State FDA Oct. 14, the injections were contaminated by bacteria. The regulatory watchdogs are now investigating how the injections were contaminated.
Serious adverse reactions were reported for six patients that received the traditional Chinese medicine injection at a Honghezhou hospital, and three of the six died Oct. 6, the local government said during a press conference.
According to MOH, the Honghezhou hospital is the only hospital to have reported adverse drug reactions.
The contaminated TCM injection, which was produced by Wandashan Pharmaceutical last December, has been used in 43,383 doses in 16 provinces across China. Sales and use of the contaminated products have been stopped and batches of other products made by Wandashan have been suspended. The injections is used for thrombosis and heart disease.
The injection is sold only in China, according to a Wandashan representative who declined to provide more details.
“[The Siberian ginseng] injection accident was caused by the quality of the product as per the results of the investigation,” Huijun Gao, director of the Shanghai Institute for Food and Drug Safety, told PharmAsia News.
Gao said that the physical appearance of the contaminated product differs from the unadulterated product. While the contaminated product is turbid in appearance, the untainted product is clear.
In the past, there have been problems with the supervision of TCM injections in China, some of which have caused serious adverse events, including a high-profile incident related to Houttuynia injection in 2006, Gao said.
“Some TCMs are safe when used as oral drugs, but when they were used as an intravenous injection, they may cause serious ADRs,” Gao said. “We didn’t do enough clinical studies in the past to ensure the safety of TCM injections,” Gao added.
Gao also pointed out that fewer TCM injections have been approved in China during the past few years, mainly because of heightened registration requirements.
SFDA issued basic technical requirements for TCM and natural drug injections at the end of 2007 (PharmAsia News, Dec. 28, 2007).
“We are also re-evaluating all TCM injections which lack clinical study support,” she said. “It will take some time to re-evaluate the approved ones.” SFDA announced in 2007 it would review registrations of all injectable drugs in China by the end of June 2008 (PharmAsia News, Sept. 10, 2007).
In a white paper issued by the government in July, China laid out a plan to raise standards and quality control measures related to the manufacturing process for TCM injections (PharmAsia News, July 21, 2008).