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Watchdog doubtful of pill's risk factor

By Wang Zhuoqiong (China Daily)
Updated: 2009-02-12 07:40

China's drug authority announced skepticism of a leading scholar's claims about the side effects of a widely used circulatory disease treatment yesterday.

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The Cardiotonic Pill - a traditional Chinese medicine (TCM) treatment - was not mentioned in the National Center's Adverse Drug Reaction (ADR) Monitoring's briefings from 2001, the State Food and Drug Administration (SFDA) said.

"We will decide whether to reevaluate this drug based on the information from our ADR monitoring system," SFDA spokeswoman Yan Jiangying said yesterday.

Used to prevent heart and blood vessel diseases, including coronary arteriosclerosis, the pills were manufactured by the publicly listed Tasly Group.

The Cardiotonic Pill has been marketed for 14 years, generating an average annual revenue of 1.2 billion yuan ($170 million).

The debate over the drug was ushered into the spotlight by Chinese Academy of Engineering researcher Li Lianda's unfinished 2008 study.

The Cardiotonic Pill's ADR incidence rate is 3.11 percent and no long-term research has been done on its side effects, the Modern Express quoted Li as saying in February.

"It will cause severe damage" to ADR-susceptible patients and can cause shock, blood in urine and enteric reactions, Li said.

Yan said the administration has monitored the ADRs of all medicines in the market and "any medicine, including vitamins, TCM that includes minerals and chemical medicines, have ADRs. But ADRs vary among individuals," she explained.