Yunnan Baiyao meds in HK recall

[kullatiro]

http://www.globaltimes.cn/content/760654.shtml

 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.

http://www.chinadaily.com.cn/china/2013-02/08/content_16213694.htm

 Traditional Chinese medicine
Yunnan Baiyao has not been
recalled on the mainland despite
Hong Kong health authorities
claiming to have discovered
"undeclared" poisonous ingredients
in some batches of the product and
ordering it to be taken off shop
shelves.
The Department of Health of Hong
Kong announced on Tuesday that it
had tested samples of capsules,
powder, plaster, aerosol and
tincture of Yunnan Baiyao
distributed by wholesaler Fung Wah
(Hong Kong) Co, and found they
contained "undeclared aconitum
alkaloids".
"According to the products'
registration details and the Chinese
medicine literature, the ingredients
in the products cannot account for
the presence of aconitum alkaloids
as detected," said the department
in its statement.
According to the statement, if used
improperly, aconitum alkaloids can
"cause discomfort, such as
numbness in the mouth and limbs,
nausea, vomiting and peripheral
weakness, and even lead to life
threatening conditions such as
breathing difficulties and cardiac
arrhythmia".
Produced by Yunnan Baiyao Group,
a medicine maker in Yunnan
province, the product is a well-
known traditional Chinese medicine
that is effective in stopping
bleeding and treating pain in
muscles and joints caused by
bruises and rheumatism.
The department said although it
has not yet received any reports of
users suffering adverse effects
from the product, it ordered the
recall.
Yunnan Baiyao Group confirmed in
an online statement on Wednesday
that such products contain
aconitum alkaloids, but the toxicity
is "greatly reduced" after "unique
methods of preparation".
The medicine is still available in
pharmacies in Beijing.