• As of 2016, the US Food and Drug Administration (FDA) recommended that "serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with acute sinusitis, acute bronchitis, and uncomplicated urinary tract infections who have other treatment options. (wikipedia.org)
  • The FDA's warnings, placed on the drugs' labels and warning inserts, aim to inform patients that the serious side effects of these medications generally outweigh the benefits, particularly if patients have other treatment options. (thelyonfirm.com)
  • Levofloxacin is a broad-spectrum antibiotic of the fluoroquinolone drug class. (wikipedia.org)
  • Gemifloxacin is a fluoroquinolone antibiotic with the antimicrobial property. (illnesshacker.com)
  • Gemifloxacin is a fourth generation, an oral fluoroquinolone antibiotic used in the therapy of mild-to-moderate respiratory tract infections caused by susceptible organisms. (illnesshacker.com)
  • Gemifloxacin is a quinolone/fluoroquinolone antibiotic. (illnesshacker.com)
  • Gemifloxacin is a broad-spectrum antibiotic that is active against both Gram-positive and Gram-negative bacteria. (illnesshacker.com)
  • Factive (gemifloxacin) is a fluoroquinolone antibiotic that fights bacteria in the body. (prescriptiondrugjournal.com)
  • The FDA's recent action follows a study by its Office of Surveillance and Epidemiology, which found "an association between fluoroquinolone antibiotic use and disabling peripheral neuropathy. (thelyonfirm.com)
  • Levofloxacin (Levaquin) , Ciprofloxacin (Cipro), Moxifloxacin (Avelox), Norfloxacin (Noroxin), Ofloxacin (Floxin), Gemifloxacin (Factive) and Finafloxacin (Xtoro) should be taken off the market, and the FDA knows it! (kpaddock.com)
  • Levofloxacin and other fluoroquinolones have also been widely used for the treatment of uncomplicated community-acquired respiratory and urinary tract infections, indications for which major medical societies generally recommend the use of older, narrower spectrum drugs to avoid fluoroquinolone resistance development. (wikipedia.org)
  • According to the FDA approved prescribing information, levofloxacin is pregnancy category C. This designation indicates that animal reproduction studies have shown adverse effects on the fetus and there are no adequate and well-controlled studies in humans, but the potential benefit to the mother may in some cases outweigh the risk to the fetus. (wikipedia.org)
  • The class of drugs-previously used as therapy of respiratory and urinary tract infections-includes ciprofloxacin, gemifloxacin, levofloxacin, moxifloxacin, norfloxacin, and ofloxacin. (rheingoldlaw.com)
  • Gemifloxacin is an oral broad-spectrum quinolone antibacterial agent used in the treatment of acute bacterial exacerbation of chronic bronchitis and mild-to-moderate pneumonia. (illnesshacker.com)
  • The news is especially troubling, as fluoroquinolones are a class of antibacterial drugs that had been used precisely for the treatment of its contraindications: acute bacterial sinusitis (ABS), acute bacterial exacerbation of chronic bronchitis in those with chronic obstructive pulmonary disease (ABECB-COPD), and uncomplicated urinary tract infection. (rheingoldlaw.com)
  • Gemifloxacin targets at both Gram-positive, -negative and atypical human pathogens. (illnesshacker.com)
  • Health care professionals should avoid prescribing fluoroquinolone antibiotics to patients who have an aortic aneurysm or are at risk for an aortic aneurysm, such as patients with peripheral atherosclerotic vascular diseases, hypertension, certain genetic conditions such as Marfan syndrome and Ehlers-Danlos syndrome, and elderly patients. (kpaddock.com)
  • Stop fluoroquinolone treatment immediately if a patient reports side effects suggestive of aortic aneurysm or dissection. (kpaddock.com)
  • Be aware that symptoms of an aortic aneurysm often do not show up until the aneurysm becomes large or bursts, so report any unusual side effects from taking fluoroquinolones to your health care professional immediately. (kpaddock.com)
  • "Use of fluoroquinolones was associated with an increased risk of aortic aneurysm and dissection," the researchers concluded. (prescriptiondrugjournal.com)
  • Another study published in BMJ Open in November 2015 looked at data on over 1.7 million older adults and found a roughly 3-fold increased risk of tendon rupture and aortic aneurysm among patients who took fluoroquinolone antibiotics. (prescriptiondrugjournal.com)
  • These individuals were 3.13 times more likely to suffer a tendon rupture and 2.72 times more likely to suffer an aortic aneurysm compared to patients who did not take fluoroquinolones. (prescriptiondrugjournal.com)
  • Recent studies, published by the American Medical Association and numerous medical journals, show a link between the use of fluoroquinolone antibiotics and a substantial risk for aortic aneurysms and aortic dissections. (thelyonfirm.com)
  • The 2015 studies identify a logical "association" between fluoroquinolone use and the development of severe aortic disorders, including fatal aortic ruptures. (thelyonfirm.com)
  • A study published in the Annals of Pharmacotherapy in December 2001 found that fluoroquinolone antibiotics like Factive can cause severe, long-term nerve damage involving multiple organ systems. (prescriptiondrugjournal.com)
  • FDA has issued at least two warnings about the rapid onset of peripheral neuropathy and the risk of permanent nerve damage associated with fluoroquinolone antibiotics like Factive. (prescriptiondrugjournal.com)
  • People at increased risk include those with a history of blockages or aneurysms (abnormal bulges) of the aorta or other blood vessels, high blood pressure, certain genetic disorders that involve blood vessel changes, and the elderly. (kpaddock.com)
  • It is already known that these drugs can severely exacerbate the risk of tendinitis, tendon rupture, prolongation of the QT interval, and peripheral neuropathy. (rheingoldlaw.com)
  • "The onset of peripheral neuropathy after starting fluoroquinolone therapy was rapid, often within a few days," FDA said. (prescriptiondrugjournal.com)
  • December 2001 - Study published in the Annals of Pharmacotherapy finds an increased risk of severe, long-term peripheral neuropathy with fluoroquinolone antibiotics. (prescriptiondrugjournal.com)
  • Safety Announcement [12-20-2018] A U.S. Food and Drug Administration (FDA) review found that fluoroquinolone antibiotics can increase the occurrence of rare but serious events of ruptures or tears in the main artery of the body, called the aorta. (kpaddock.com)
  • A study published in JAMA Internal Medicine in November 2015 found that fluoroquinolone antibiotics may cause the aorta - the largest artery in the human body - to become abnormally enlarged. (prescriptiondrugjournal.com)
  • Several patients were continued on the fluoroquinolone drug despite the occurrence of neuropathic symptoms. (prescriptiondrugjournal.com)
  • Most published comparative trials describe these risks among the drug class, but do not focus on the incidence of serious arrhythmias, seizures, hallucinations tendon rupture, or photosensitivity. (rheingoldlaw.com)
  • That year they added the "black box" warning to seven fluoroquinolone drug labels and prescribing information, primarily because of the added risk of tendon rupture. (thelyonfirm.com)
  • While use during pregnancy is not recommended, risk appears to be low. (wikipedia.org)
  • Gemifloxacin has been linked to rare instances of acute liver injury. (illnesshacker.com)
  • The current labelling already includes warnings about the risks for each of these adverse effects, as well as other central nervous system effects, Torsades de Pointes, phototoxicity, hypersensitivity, and myasthenia gravis exacerbation. (rheingoldlaw.com)
  • The U.S. Food and Drug Administration (FDA) recently released new warnings on the "disabling" side effects from the commonly used class of antibiotics called fluoroquinolones. (thelyonfirm.com)
  • As far back as 2008 the FDA knew about major concerns and risks for this class of antibiotics. (thelyonfirm.com)
  • Fluoroquinolones should not be used in patients at increased risk unless there are no other treatment options available. (kpaddock.com)
  • Prescribe fluoroquinolones to these patients only when no other treatment options are available. (kpaddock.com)
  • For patients with these conditions, fluoroquinolones should be reserved for those who do not have alternative treatment options. (wikipedia.org)
  • In some patients the symptoms had been ongoing for more than a year despite discontinuation of the fluoroquinolone. (prescriptiondrugjournal.com)
  • Approximately 30% of patients in the study had filled at least one fluoroquinolone prescription in the last 30 days. (prescriptiondrugjournal.com)
  • For patients with these conditions, fluoroquinolones should only be prescribed when there are no other treatment options, according to the FDA. (prescriptiondrugjournal.com)
  • Fluoroquinolone side effects may include damage to tendons, muscles, joints, nerves and the central nervous system. (prescriptiondrugjournal.com)
  • While these were rare events, physicians should be aware of this possible drug safety risk associated with fluoroquinolone therapy. (prescriptiondrugjournal.com)
  • In May 2016, the FDA required fluoroquinolone labels to be updated with a warning about an increased risk for damage to muscles, nerves and more. (prescriptiondrugjournal.com)
  • Although the concentrations of gemifloxacin used were higher than those observed in the serum of human volunteers treated with the dose under clinical development, it should be taken into consideration that concentrations at tissue and intracellular levels may be considerably higher than serum concentrations. (illnesshacker.com)
  • In the FDA Adverse Event Reporting database, there are over 1,000 reports of nerve damage after fluoroquinolone use, and only 10 percent reported improvement or recovery. (thelyonfirm.com)
  • Whereas LPS induced a rapid increase in NF-kappa B activation, gemifloxacin alone did not. (illnesshacker.com)
  • Available data point to a low risk for the unborn child. (wikipedia.org)
  • The Firm offers contingency fees, advancing all costs of the litigation, and accepting the full financial risk, allowing our clients full access to the legal system while reducing the financial stress while they focus on their healthcare and financial needs. (thelyonfirm.com)