China’s drug safety watchdog has ordered traditional Chinese medicine (TCM) maker Yunnan Baiyao to boost awareness of one of its drug’s side effects and remind patients to use it properly.
Yunnan Baiyao manufactures a drug of the same name that is used to treat open wounds and muscle pain. The composition of the drug is under state-level protection.
The Department of Health of the Hong Kong special administrative region on Tuesday recalled the drug after finding that it contained an undeclared amount of aconitum alkaloids.
Aconitum alkaloids can be toxic. If ingested improperly, they can cause numbness of the mouth and limbs, nausea, vomiting and peripheral weakness, and even lead to life-threatening conditions like breathing difficulties and cardiac arrhythmia, according to the department.
An official from the State Food and Drug Administration (SFDA) said Wednesday that the administration has followed related cases concerning the drug’s safety.
The SFDA also ordered the drug maker to warn patients that they should not use the drug without authorization, increase their dosage or prolong the duration of use, the official said.
Yunnan Baiyao responded in a Wednesday statement, saying that through special production processes and techniques, the toxicity of the aconitum alkaloids contained in the drug can be removed or alleviated.
According to statistics from Yunnan Baiyao, the company detected a total of 28 adverse reactions to its product between 2010 and 2012, mostly skin allergies and itching. No serious adverse drug reactions were found.