The agency also cautioned that these bacteria-fighting drugs -- including levofloxacin (Levaquin) and ciprofloxacin (Cipro) -- shouldn't be prescribed for sinusitis, chronic bronchitis or simple urinary tract infections unless no other treatments options exist."Fluoroquinolones have risks and benefits that should be considered very carefully," Dr. He's director of the Office of Antimicrobial Products at the FDA's Center for Drug Evaluation and Research."It's important that both health care providers and patients are aware of both the risks and benefits of fluoroquinolones and make an informed decision about their use," Cox said. Food and Drug Administration announced Tuesday that it's strengthening label warnings on a class of antibiotics called fluoroquinolones because the drugs can lead to disabling side effects, including long-term nerve damage and ruptured tendons. A safety review revealed that potentially permanent side effects involving tendons, muscles, joints, nerves and the central nervous system can occur hours or weeks after exposure to fluoroquinolone pills or injections. Also, two or more serious side effects can occur together, the FDA said. Because of this, the FDA recommends reserving these antibiotics for serious bacterial infections, such as anthrax, plague and bacterial pneumonia. In these cases, "the benefits of fluoroquinolones outweigh the risks and it is appropriate for them to remain available as a therapeutic option," the agency said. Besides Cipro and Levaquin, other fluoroquinolones include moxifloxacin (Avelox), ofloxacin (Floxin) and gemifloxacin (Factive). Levofloxacin is used to treat infections including: respiratory tract infections, cellulitis, urinary tract infections, prostatitis, anthrax, endocarditis, meningitis, pelvic inflammatory disease, traveler's diarrhea, tuberculosis, and plague 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. For patients with these conditions, fluoroquinolones should be reserved for those who do not have alternative treatment options." Levofloxacin is used for the treatment of pneumonia, urinary tract infections, and abdominal infections. As of 2007 the Infectious Disease Society of America (IDSA) and the American Thoracic Society recommended levofloxacin and other respiratory fluoroquinolines as first line treatment for community acquired pneumonia when co-morbidities such as heart, lung, or liver disease are present or when in-patient treatment is required. 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. Due to its widespread use, common pathogens such as Escherichia coli and Klebsiella pneumoniae have developed resistance. In many countries as of 2013, resistance rates among healthcare-associated infections with these pathogens exceeded 20%. Levofloxacin is also used as antibiotic eye drops to prevent bacterial infection.
INDIANAPOLIS— The makers of a popular antibiotic have halted production on the drug amid safety concerns. Janssen pharmaceutical companies of Johnson & Johnson discontinued production of Levaquin in December 2017, including the oral and IV versions. However, Levaquin may still be available in pharmacies until 2020.“The decision to discontinue LEVAQUIN was made due to the wide availability of alternative treatment options, and our focus on developing innovative medicines designed to address unmet medical patient needs,” said Kelsey Buckholtz, a spokeswoman for Janssen in an email to RTV6. The new labels will include more prominent and consistent warnings for mental health side effects. A Janssen spokeswoman said Tuesday the company also discontinued making Floxin Otic ear drops, which is also a fluoroquinolone. For several years, Call 6 Investigates has been looking into potential safety issues and concerning side effects associated with fluoroquinolone antibiotics including psychiatric problems, tendon rupture and nerve damage. Purdue University student Shea Mc Carty died in 2013 after jumping out of a second story window and crashing his car into a cement embankment. His mother, Heather Mc Carthy, said Shea was agitated and suffering mental health side effects from taking the antibiotic Levaquin. Charles Bennett with the Southern Network on Adverse Reactions (SONAR) said Tuesday that Janssen’s decision will have little impact on public safety because other drug makers are still making the generic form, known as levofloxacin.“Levaquin was only about 1 percent of the market share, and 99 percent was the generic,” said Bennett. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. A 5-day course of 750 milligrams of levofloxacin given intravenously and/or by mouth once daily will be compared to a 10-day course of 400 milligrams of ciprofloxacin given intravenously and/or 500 milligrams of ciprofloxacin given by mouth twice daily. Listing a study does not mean it has been evaluated by the U. Levofloxacin has been approved in both its oral and intravenous forms to treat a large number of infections caused by bacteria. The purpose of this study is to evaluate the effectiveness and safety of two antibiotics in the treatment of complicated urinary tract infection or acute pyelonephritis (kidney infection). Levofloxacin and other members of a class of antibiotics known as fluoroquinolones have been used successfully to treat urinary and kidney infections. This study will compare the effectiveness and safety of levofloxacin given for 5 days to that of another fluoroquinolone, ciprofloxacin, given for 10 days in treating complicated urinary tract infection or acute pyelonephritis (kidney infection). A shorter course of antibiotics may help patients take all of their medication, which is critically important for curing the infection. A shorter course may also help prevent the development of bacteria that cannot be killed by antibiotics.
Avoid Cipro!- I'm dropping in a quick cautionary post to urge ALL who are hypermobile whether you have EDS or not, diagnosed or not to AVOID all antibiotics from the fluoroquinolone or "quin" family but especially "Cipro". Dec 21, 2018. These drugs are under the names ciprofloxacin Cipro, gemifloxacin Factive, levofloxacin Levaquin, moxifloxacin Avelox, norfloxacin.