The State Food and Drug Administration (SFDA)
issued a notice on its website on Tuesday that some
anti-inflammatory drugs have been connected with possible serious
side effects.
The administration reported that in a small proportion of cases,
nonsteroidal anti-inflammatory drugs (NSAIDs) have been associated
with cardiovascular events and gastrointestinal bleeding.
NSAIDs are commonly used to treat pain and inflammation and are
available in both prescription and over-the-counter varieties.
Well-known brands include Fenbid, Voltaren and Celebrex, and OTC
products such as Aleve, Motrin and Advil.
Last week, the US Food and Drug Administration (FDA) issued a
public health advisory on NSAIDS?as it urged manufacturers to
expand their box label warnings to include information on the
cardiovascular and gastrointestinal risks, as well as warnings
about potential skin reactions in over-the-counter NSAIDs.
The FDA asked Pfizer, Inc., to voluntarily withdraw Bextra
(valdecoxib) from the market owing to the lack of adequate data on
the cardiovascular safety of long-term use and the increased risk
of adverse CV events in short-term coronary artery bypass surgery
(CABG) trials. It also cited reports of serious, unpredictable but
potentially life-threatening skin reactions, including deaths, in
patients using Bextra. Pfizer agreed to
suspend sales and marketing of Bextra in the US.
The FDA also issued guidelines to physicians prescribing NSAIDS
and advised patients taking OTC varieties of the drugs to follow
labeled directions carefully and contact their physicians with any
questions or concerns.
According to the Beijing Morning Post, Beijing
authorities will not require the revision of labels of such drugs
and there are no plans to recall them.
Cong Luoluo, with the Beijing Drug Administration, told the
newspaper that all drugs have side effects and NSAIDs are no
exception.
Beijing authorities have already strengthened the monitoring of
such drugs, the official was quoted as saying, although no details
were provided.
With local drug authorities across China also downplaying the
risks, so far there has been no significant downturn in sales of
the drugs.
(China Daily April 13, 2005)