BEIJING, June 26 (Xinhua) -- Permax, a drug taken for
Parkinson's disease, is to be gradually removed from the Chinese market because
of the risk of heart damage, the State Food and Drug Administration (SFDA)
announced on Tuesday.
As stopping Permax suddenly could be dangerous, the
administration ordered its production, sale and use in China to be completely
suspended by Jan. 1, 2008.
The SFDA said it made the decision because "the risks
of Permax outweigh the possible benefits for the patients based on analyses from
home and abroad".
Pergolide Mesylate, or Permax, was approved in 1988
for treatment of the signs and symptoms of Parkinson's disease.
Two studies published in The New England Journal of
Medicine in January 2007 confirmed previous studies that linked Permax to heart
valve disease.
However, the SFDA has received no reports on adverse
reactions to Permax since 1996 when it was introduced to the Chinese market.
Several countries, including the United States, the
Republic of Korea, Bahrain and Israel, have halted the marketing of Permax.
The SFDA warned that Permax should not be stopped
abruptly and suggested gradually decreasing dosages for Parkinson patients, who
should consult medical professionals to find alternative treatments.
China has two companies producing Permax, one in
Tianjin and the other in Shanghai.
There are about 1.7 million Parkinson patients in
China.