China's drug regulator on Wednesday ordered the withdrawal of a hemorrhoid medicine over concern it might cause liver problems.
The State Food and Drug Administration (SFDA) ordered the Sichuan-based Vital Pharmaceutical Holdings Ltd. to stop producing and selling Zhixue capsules and begin a nationwide recall.
The recall came after 21 people around the country developed liver problems after taking the medicine in recent months, according to Sichuan's local drug safety authority. At least 14 other patients also reported various adverse reactions after using the medicine, it said.
"An obvious connection can be found between the hemorrhoid medicine and the liver damage after case analysis," the SFDA said on its website, "but the cause of the adverse reactions remains unknown."
The SFDA has advised the public not to use the drug and ordered the manufacturer to investigate the cause of liver injuries and conduct a reassessment of its risk analysis of the drug.
China has made progress in dealing with reporting of adverse drug reactions since 2000, by using a system of electronic reporting and online real-time reporting.
In 2007, some 400 such cases per million people were reported, a ratio approaching that of developed countries. This demonstrated the marked improvement in China's monitoring and early-warning abilities.
Drug administrations promptly collect, evaluate and publish information about adverse reactions. As of June, they had issued 13 bulletins about such cases, involving 44 types of drugs.
(Xinhua News Agency November 13, 2008)