Claim: The FDA has updated its warnings for — and recommended limitations on — prescribing a class of antibiotics called fluoroquinolones, citing potentially irreversible side-effects including tendon damage and rupture.
Verdict: SUPPORTS

Retrieved passages:
title: Levofloxacin
text: The FDA wrote: "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." Such injuries, including tendon rupture, has been observed up to 6 months after cessation of treatment; the elderly, transplant patients, and those with a current or historical corticosteroid use are at elevated risk. A detailed overview of risk factors for fluoroquinolone-associated tendon rupture has been published; advanced age, concurrent treatment with corticosteroids, and

title: Quinolone antibiotic
text: and uncomplicated urinary tract infections. Reports of serious adverse events began emerging, and The FDA first added a Boxed Warning to fluoroquinolones in July 2008 for the increased risk of tendinitis and tendon rupture. In February 2011, the risk of worsening symptoms for those with myasthenia gravis was added to the Boxed Warning. In August 2013, the agency required updates to the labels to describe the potential for irreversible peripheral neuropathy (serious nerve damage). In November 2015, an FDA Advisory Committee discussed the risks and benefits of fluoroquinolones for the treatment of acute bacterial sinusitis, acute bacterial exacerbation of chronic

title: Quinolone antibiotic
text: uncomplicated urinary tract infections when there are other treatment options. In 2008 the FDA added black box warning on all fluoroquinolones, advising of the increased risk of tendon damage. In 2016 the FDA found that when used systemically (by mouth or injectable) "disabling and potentially permanent serious side effects" can involve the tendons, muscles, joints, nerves, and central nervous system. Concerns regarding low blood sugar and mental health problems were added in 2018. Quinolones are associated with a small risk of tendonitis and tendon rupture; a 2013 review found the incidence of tendon injury among those taking fluoroquinolones to be

title: Norfloxacin
text: that are associated with all members of the fluoroquinolone antibacterial class. Among these, tendon problems and exacerbation of the symptoms of the neurological disorder myasthenia gravis are the subject of "black box" warnings in the United States. The most severe form of tendonopathy associated with fluoroquinolone administration is tendon rupture, which in the great majority of cases involves the Achilles tendon. Younger people typically experience good recovery, but permanent disability is possible, and is more likely in older patients. The overall frequency of fluoroquinolone-associated Achilles tendon rupture in patients treated with ciprofloxacin or levofloxacin has been estimated at 17 per

title: Gemifloxacin
text: or more of the following antibiotics: penicillin, 2nd generation cephalosporins, e.g., cefuroxime, macrolides, tetracyclines and trimethoprim/sulfamethoxazole. Fluoroquinolones are generally well tolerated with most side effects being mild and serious adverse effects being rarely. Some of the serious adverse effects which occur more commonly with fluoroquinolones than with other antibiotic drug classes include CNS and tendon toxicity. The currently marketed quinolones have safety profiles similar to that of other antimicrobial classes. The serious events may occur with therapeutic or with acute overdose. At therapeutic doses they include: central nervous system toxicity, cardiovascular toxicity, tendon / articular toxicity, and rarely hepatic toxicity.

title: Ofloxacin
text: neurological disorder myasthenia gravis are the subject of "black box" warnings in the United States. The most severe form of tendonopathy associated with fluoroquinolone administration is tendon rupture, which in the great majority of cases involves the Achilles tendon. Younger people typically experience good recovery, but permanent disability is possible, and is more likely in older patients. The overall frequency of fluoroquinolone-associated Achilles tendon rupture in patients treated with ciprofloxacin or levofloxacin has been estimated at 17 per 100,000 treatments. Risk is substantially elevated in the elderly and in those with recent exposure to topical or systemic corticosteroid therapy. Simultaneous

title: Ofloxacin
text: adverse events in patients treated with fluoroquinolones is roughly similar to that seen in patients treated with other antibiotic classes. A U.S. Centers for Disease Control study found patients treated with fluoroquinolones experienced adverse events severe enough to lead to an emergency department visit more frequently than those treated with cephalosporins or macrolides, but less frequently than those treated with penicillins, clindamycin, sulfonamides, or vancomycin. Post-marketing surveillance has revealed a variety of relatively rare but serious adverse effects that are associated with all members of the fluoroquinolone antibacterial class. Among these, tendon problems and exacerbation of the symptoms of the

title: Quinolone antibiotic
text: between 0.08 and 0.2%. The risk appears to be higher among people older than 60 and those also taking corticosteroids; there may also be higher risk among people who are male, have a pre-existing joint or tendon issue, have kidney disease, and are highly active. Some experts have advised avoidance of fluoroquinolones in athletes. If tendonitis occurs, it generally appears within one month, and the most common tendon that is injured appears to be the Achilles tendon. The cause is not well understood. Nervous system effects include insomnia, restlessness, and rarely, seizure, convulsions, and psychosis. Other rare and serious adverse

title: Gemifloxacin
text: Events that may occur in acute overdose are rare and include: renal failure and seizure. Children and the elderly are at greater risk. Tendon damage may manifest during, as well as up to a year after fluoroquinolone therapy. The FDA ordered a black box warnings on all fluoroquinolones advising consumers of the possible toxic effects of fluoroquinolones on tendons. On August 15, 2013 the FDA issued a Safety Announcement where they described that they are requiring the medication guides and drug labels for all fluoroquinolones to be updated and better describe the risk for peripheral neuropathy. The peripheral neuropathy may

title: Quinolone antibiotic
text: as well as headache and insomnia. Postmarketing surveillance has revealed a variety of relatively rare but serious adverse effects that are associated with all members of the fluoroquinolone antibacterial class. Among these, tendon problems and exacerbation of the symptoms of the neurological disorder myasthenia gravis are the subject of "black box" warnings in the United States. The overall rate of adverse events in people treated with fluoroquinolones is roughly similar to that seen in people treated with other antibiotic classes. A U.S. Centers for Disease Control and Prevention study found peopletreated with fluoroquinolones experienced adverse events severe enough to lead

title: Quinolone antibiotic
text: bronchitis and uncomplicated urinary tract infections based on new safety information. The new information focused on two or more side effects occurring at the same time and causing the potential for irreversible impairment. The advisory committee concluded that the serious risks associated with the use of fluoroquinolones for these types of uncomplicated infections generally outweighed the benefits for patients with other treatment options. The 21-member joint committee overwhelmingly recommended stronger label warnings on the containers because of rare but sometimes devastating side effects. On May 12, 2016, the FDA issued a drug safety communication advising that fluoroquinolones should be reserved

title: Norfloxacin
text: 100,000 treatments. Risk is substantially elevated in the elderly and in those with recent exposure to topical or systemic corticosteroid therapy. Simultaneous use of corticosteroids is present in almost one-third of quinolone-associated tendon rupture. Tendon damage may manifest during, as well as up to a year after fluoroquinolone therapy has been completed. FQs prolong the QT interval by blocking voltage-gated potassium channels. Prolongation of the QT interval can lead to torsades de pointes, a life-threatening arrhythmia, but in practice this appears relatively uncommon in part because the most widely prescribed fluoroquinolones (ciprofloxacin and levofloxacin) only minimally prolong the QT interval.

title: Ciprofloxacin
text: dosages, all drug-therapy durations, and for all indications, were nausea (2.5%), diarrhea (1.6%), abnormal liver function tests (1.3%), vomiting (1%), and rash (1%). Other adverse events occurred at rates of <1%. The black box warning on the ciprofloxacin label in the United States warns of an increased risk of tendinitis and tendon rupture, especially in people who are older than 60 years, people who also use corticosteroids, and people with kidney, lung, or heart transplants. Tendon rupture can occur during therapy or even months after discontinuation of the medication. One study found that fluoroquinolone use was associated with a 1.9-fold

title: Ciprofloxacin
text: than it would have been otherwise. Resistance to ciprofloxacin and other fluoroquinolones may evolve rapidly, even during a course of treatment. Numerous pathogens, including enterococci, "Streptococcus pyogenes" and "Klebsiella pneumoniae" (quinolone-resistant) now exhibit resistance. Widespread veterinary usage of the fluoroquinolones, particularly in Europe, has been implicated. Meanwhile, some "Burkholderia cepacia", "Clostridium innocuum" and "Enterococcus faecium" strains have developed resistance to ciprofloxacin to varying degrees. Fluoroquinolones had become the class of antibiotics most commonly prescribed to adults in 2002. Nearly half (42%) of those prescriptions in the U.S. were for conditions not approved by the FDA, such as acute bronchitis, otitis

title: Norfloxacin
text: occur. Common side-effects include gastrointestinal effects such as nausea, vomiting, and diarrhea, as well as headache and insomnia. The overall rate of adverse events in patients treated with fluoroquinolones is roughly similar to that seen in patients treated with other antibiotic classes. A U.S. Centers for Disease Control study found patients treated with fluoroquinolones experienced adverse events severe enough to lead to an emergency department visit more frequently than those treated with cephalosporins or macrolides, but less frequently than those treated with penicillins, clindamycin, sulfonamides, or vancomycin. Post-marketing surveillance has revealed a variety of relatively rare but serious adverse effects

title: Norfloxacin
text: population. Fluoroquinolones are not licensed by the FDA for use in children due to the risk of fatalities as well as permanent injury to the musculoskeletal system, with two exceptions. Ciprofloxacin is being licensed for the treatment of Complicated Urinary Tract Infections and Pyelonephritis due to Escherichia coli and Inhalational Anthrax (post-exposure) and levofloxacin was recently licensed for the treatment of Inhalational Anthrax (post-exposure). However, the Fluoroquinolones are licensed to treat lower respiratory infections in children with cystic fibrosis in the UK. In general, fluoroquinolones are well tolerated, with most side-effects being mild to moderate. On occasion, serious adverse effects

title: Flumequine
text: drugs package inserts include a Black Boxed Warning concerning the risk of spontaneous tendon ruptures, which would have included flumequine. The FDA also requested that the manufacturers send out Dear Doctor Letters regarding this new warning. Such tendon problems have also been associated with flumequine. The use of flumequine in food animals had sparked considerable debate. Significant and harmful residues of quinolones have been found in animals treated with quinolones and later slaughtered and sold as food products. There has been significant concern regarding the amount of flumequine residue found within food animals such as fish, poultry and cattle. In

title: Quinolone antibiotic
text: An estimated 130,000 pediatric prescriptions for levofloxacin were filled on behalf of 112,000 pediatric patients during that period. Meta-analyses conclude that fluoroquinolones pose little or no additional risk to children compared to other antibiotic classes. Fluoroquinolines use in children may be appropriate when the infection is caused by multidrug-resistant bacteria, or when alternative treatment options require parenteral administration and oral therapy is preferred. While typical drug side effects reactions are mild to moderate; sometimes serious adverse effects occur. In 2016, the U.S. FDA stated that serious side effects generally outweighed the benefits for people with acute sinusitis, acute bronchitis, and

title: Ofloxacin
text: use of corticosteroids is present in almost one-third of quinolone-associated tendon rupture. Tendon damage may manifest during, as well as up to a year after fluoroquinolone therapy has been completed. FQs prolong the QT interval by blocking voltage-gated potassium channels. Prolongation of the QT interval can lead to torsades de pointes, a life-threatening arrhythmia, but in practice this appears relatively uncommon in part because the most widely prescribed fluoroquinolones (ciprofloxacin and levofloxacin) only minimally prolong the QT interval. "Clostridium difficile"-associated diarrhea may occur in connection with the use of any antibacterial drug, especially those with a broad spectrum of activity

title: Quinolone antibiotic
text: In most countries, fluoroquinolones are approved for use in children only under narrowly-defined circumstances, owing in part to the observation of high rates of musculoskeletal adverse events in fluoroquinolone treated juvenile animals. In the UK, the prescribing indications for fluoroquinolones for children are severely restricted. Only inhalant anthrax and pseudomonal infections in cystic fibrosis infections are licensed indications in the UK due to ongoing safety concerns. In a study comparing the safety and efficacy of levofloxacin to that of azithromycin or ceftriaxone in 712 children with community-acquired pneumonia, serious adverse events were experienced by 6% of those treated with levofloxacin