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 an alternative
treatment.
China has two companies producing Permax, one in Tianjin and the
other in Shanghai.
There are about 1.7 million Parkinson patients in China.
(Xinhua News Agency June 27, 2007)