FDA Increases Warnings Associated with Fluoroquinolone Antibiotics, Including Cipro and Levaquin
The U.S. Food and Drug Administration recently issued a new warning increasing the cautions associated with fluoroquinolone-based medications, concluding that this class of antibiotics may be too strong to address bronchitis, sinus infections, and urinary tract infections. The FDA has received a number of complaints regarding the drugs and has concluded that dangerous side effects include disabling and potentially irreversible tendon, muscle, joint, nerve, and central nervous system pain. The warning label for these drug products has been updated to reflect these new risks.
The agency also stated in its warning that fluoroquinolones should only be prescribed to patients who have no other medical recourse for acute bacterial exacerbation of chronic bronchitis, uncomplicated urinary tract infections, or acute bacterial sinusitis. More specifically, health care professionals should immediately stop prescribing these medications for patients who have any of these conditions and support any serious adverse reactions as soon as possible. The current Boxed Warning for fluoroquinolone medicines applies to a number of conditions like tendon rupture, myasthenia gravis, and tendinitis, as well as peripheral neuropathy and a variety of other conditions.
Patients who have been injured as a result of taking dangerous pharmaceuticals can file a product liability or negligence claim against the drug manufacturer. The FDA requires drug manufacturers to comply with extensive regulations regarding the development, testing, approval, and marketing of new drugs. In many instances, companies that manufacture and sell dangerous pharmaceuticals have failed to comply with some of the testing requirements or even hidden information from the FDA about adverse side effects associated with the drugs when seeking approval.
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