FDA issues safety warning of fluoroquinolones

On July 26, 2016, the U.S Food and Drug Administration (FDA) approved the release of safety warnings on fluoroquinolones Declare that these drugs are at risk of disability and potential permanent side effects, and limit their use in patients with non serious bacterial infections Dr Edward Cox, director of the antibacterial products office of the FDA drug evaluation and Research Center, said: the advantages and disadvantages of fluoroquinolones need to be carefully considered Medical workers and patients should know the advantages and disadvantages of fluoroquinolones and make a careful decision on whether to use them The FDA study found that fluoroquinolones may cause a series of side effects of disability involving tendons, muscles, joints, nerves and central nervous system These side effects may occur in a few hours or even weeks after administration, and may even form permanent damage Because the risk of serious side effects exceeds the advantages of fluoroquinolones in the treatment of patients with acute bacterial sinusitis, acute attack of chronic bronchitis and simple urinary tract infection The FDA decided not to recommend the use of fluoroquinolones, even if there was no alternative treatment However, for the patients with serious infection such as anthrax, plague and bacterial pneumonia, fluoroquinolones are still reserved as the alternative treatment because of the high risk of disease At present, the fluoroquinolones approved by FDA include levofloxacin, ciprofloxacin, ciprofloxacin sustained-release tablets, moxifloxacin, ofloxacin and jimifloxacin At present, the FDA has issued a variety of warnings, including new restrictions on use The FDA also requires doctors to prescribe such drugs and describe safety issues to patients As early as July 2008, the FDA issued a warning about the risk that fluoroquinolones may cause tendinitis and tendon rupture In February 2011, the FDA issued another warning that it may aggravate the symptoms of myasthenia gravis patients In August 2013, FDA increased the risk warning of peripheral neuropathy caused by such drugs In November 2015, the FDA advisory committee discussed the risk and efficacy of fluoroquinolones in the treatment of acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis and simple urinary tract infection based on new safety information This information focuses on the simultaneous occurrence of two or more side effects and potential irreversible damage After discussion, the Committee concluded that the serious risk of such drugs may be far greater than the therapeutic effect on patients in these uncomplicated infections Fluoroquinolones have been widely used in China for a long time because of their wide antibacterial spectrum, long-term effect, good absorption, wide tissue distribution and effective oral administration Especially in areas where the incidence rate of respiratory diseases in the north is high, fluoroquinolones are highly used and widely used in the treatment of common infectious diseases such as urinary tract infections The release of the warning is expected to attract the attention of medical workers and patients If it is not serious infection, try to avoid the use of such drugs At the same time, it is also hoped that the relevant departments of the state will formulate new instructions and relevant restrictions on the use of such drugs as soon as possible according to the current clinical data Avoid unnecessary safety risks as much as possible Note: the content of this article is original by the author of yaozhi.com, welcome to reprint, please indicate the source and author when reprint, thank you!