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)
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