Yunnan Baiyao meds in HK recall

The country's food and drug safety watchdog Wednesday urged Yunnan Baiyao Group, a leading Traditional Chinese Medicine (TCM) producer, to monitor side effects of its medicine to ensure safety after the Hong Kong Department of Health ordered a recall of medicine made by the company for containing an undeclared substance.

The State Food and Drug Administration (SFDA) has been holding talks with managers of Yunnan Baiyao and asked the company to amend instructions for its products and add safety risk information after media reported concerns over the safety of aconitum alkaloids, a substance contained in some Yunnan Baiyao medicines, the administration said in a statement Wednesday.

The toxicity of aconitum alkaloids is minimized with processing. If the company follows quality management rules and the formulation process approved by the administration, its products are safe, the statement said.

On Tuesday, the Department of Health (DH) in Hong Kong announced a recall of five types of medicine produced by Yunnan Baiyao, including Yunnan Baiyao capsules, Yunnan Baiyao powder and Yunnan Baiyao plaster, because they contained undeclared aconitum alkaloids.

"If used improperly, aconitum alkaloids can cause discomfort like numbness of the mouth and limbs, nausea, vomiting and peripheral weakness, and even lead to life-threatening conditions like breathing difficulties and cardiac arrhythmia," the DH said in a statement.

The DH said the product safety investigation is ongoing and so far no adverse event related to the use of the products has been reported to the DH.

In a statement published on its website Wednesday, Yunnan Baiyao Group said the effectiveness and safety of its medicine is unquestionable because the toxicity of aconitum alkaloids is greatly lessened after special processing by the company.

"The company's medicine is a prescription drug. As along as patients follow their doctors' instructions regarding the dosage, the medicine is safe to consume," a staff member at Yunnan Baiyao told the Global Times Wednesday, speaking on condition of anonymity.

The company's drugs are famous for treating open wounds, and the ingredients are closely guarded secrets protected by the State.

Testing by Yunnan Baiyao found 28 cases of side effects in its medicine between 2010 and 2012, mainly involving skin allergies and itching, with no serious effects reported, the company's statement said.

This is not the first time the safety of the company's medicine has been questioned. In January, the Sichuan Food and Drug Administration banned sales of Yunnan Baiyao capsules after they were found to contain elevated levels of water.

"Recent concerns over the potential safety hazards of Yunnan Baiyao medicine could tarnish the company's brand image and affect sales of its sideline products such as toothpaste and shampoo, which account for an increasingly large proportion of the company's revenue," Huang Hailong, an analyst at Beijing-based Adfaith Management Consulting, told the Global Times.

Yunnan Baiyao reported 9.5 billion yuan ($1.5 billion) of business revenue in the first three quarters of 2012, up 23.23 percent from the previous year.