China Recalls Hemorrhoid Drug Over Liver Damage Fears
China's drug regulator, the State Food and Drug Administration (SFDA), ordered the withdrawal of a hemorrhoid medicine over concerns that it might cause liver problems.
The Sichuan-based Vital Pharmaceutical Holdings Ltd. was ordered by the SFDA to stop producing and selling Zhixue capsules and asked to begin a nationwide recall Xinhua news agency reported. The recall came after 21 people around the country developed liver problems and 14 others reported adverse reactions to the medication in recent months, the agency reported.
On its website the SFDA said, “An obvious connection can be found between the hemorrhoid medicine and the liver damage after case analysis, but the cause of the adverse reactions remains unknown."
The SFDA has advised the public to discontinue using the drug and asked the manufacturer to investigate the cause of liver injuries and conduct a reassessment of its risk analysis of the drug.
Bans and recalls of Chinese food and drug products are common though it has made progress in handling adverse drug reactions by using a system of electronic reporting and online real-time reporting since 2000. 400 cases per million people were reported in 2007, which is approaching a ratio of developed countries. Information about adverse reactions is promptly collected, evaluated and published by drug administrators. As of June, they had issued 13 bulletins about such cases, involving 44 types of drugs.