FDA Increases Warnings with Fluoroquinolone Antibiotics

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.

As a result, the companies may have failed to include warnings about dangerous side effects associated with the drugs. In a negligence action, the defendant may be held liable if the plaintiff proves that the defendant knew or should have known about the dangerous side effects and failed to include appropriate warnings with the product. In a product liability claim, the plaintiff must show that the defendant’s product was designed in an unreasonably dangerous manner, which includes considerations of whether or not the defendant included appropriate warnings with the product.

The experienced fluoroquinolone lawyers at Moll Law Group have significant experience handling claims involving Levaquin and Cipro. If you have been prescribed these drugs by your health care professional and suffered injuries as a result, you may be entitled to compensation. We can assist you with each stage of your dangerous drug claim, including investigation, filing, negotiating with insurance companies, and litigating at trial. We serve clients throughout the United States, including in New York, Florida, Illinois, and Texas. Call us at 312-462-1700 or contact us online to schedule a free consultation.

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