www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyalertsforHumanMedicalProducts/ucm500665.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery FDA Makes Changes to Warning Labels
In May of 2016, the FDA announced that the risks of fluoroquinolone antibiotics outweigh their benefits for treatment of many common infections—including urinary tract infections, sinus infections, and bronchitis. Because of this decision, fluoroquinolone manufacturers (Bayer and Johnson & Johnson) are being required to change the warning labels on this type of drugs.
The FDA announcement stated:
FDA is advising that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who have other treatment options. For patients with these conditions, fluoroquinolones should be reserved for those who do not have alternative treatment options.
An FDA safety review has shown that fluoroquinolones when used systemically (i.e. tablets, capsules, and injectable) are associated with disabling and potentially permanent serious side effects that can occur together. These side effects can involve the tendons, muscles, joints, nerves, and central nervous system.
As a result, FDA is requiring the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs to be updated to reflect this new safety information. FDA is continuing to investigate safety issues with fluoroquinolones and will update the public with additional information if it becomes available.
www.collective-evolution.com/2016/05/17/be-warned-fda-issues-new-stronger-warnings-about-risks-of-fluoroquinolone-antibiotics/