China's drug watchdog on Friday ordered the suspension of
production, sale and use of Zelnorm, a drug taken for irritable
bowel syndrome (IBS) after the medicine was linked to an increase
risk of heart attacks and strokes.
The State Food and Drug Administration said it had made the
decision because "the risks of Zelnorm outweigh the possible
benefits for some patients based on analyses from home and
abroad."
Zelnorm was approved in 2002 for treatment of irritable bowel
syndrome and constipation.
However, the National Center for Adverse Drug Reaction
Monitoring has received 98 reports of adverse reactions concerning
Zelnorm since 2003 when the medicine was introduced to the Chinese
market.
Major reactions were diarrhoea and nausea, according to the
center, adding that there was one case of tachycardia - abnormally
rapid beating of the heart - two concerning heart palpitations and
one case of low blood pressure.
A review of data from 18,000 patients taking the medicine
conducted by Novartis AG, Switzerland's largest drug maker, showed
that a significant number had experienced cardiovascular
problems.
Several countries including the United States and Canada have
recently called a halt to the marketing of Zelnorm which have been
approved in 55 countries in the world.
China now has three drug companies producing Zelnorm. The drug
is available in more than 20 provinces, regions and municipalities
at present with hundreds of thousands of users.
(Xinhua News Agency June 9, 2007)