Levofloxacin 500 mg how long does it take to work

Levaquin

Levaquin is the brand name for levofloxacin, a prescription antibiotic drug used to treat a variety of bacterial infections, such as:

  • Pneumonia
  • Acute bacterial sinusitis
  • Chronic bronchitis worsened by bacterial infections
  • Skin infections
  • Chronic prostate gland infection (prostatitis)
  • Urinary tract infection (UTI)
  • Acute kidney infection
  • Inhalational anthrax, or anthrax contracted by breathing in anthrax spores
  • Pneumonic and septicemic plague (Levaquin is also used to prevent contracting plague)

Levaquin belongs to a class of antibacterial agents called fluoroquinolones, which kill bacteria by inhibiting the activity of certain enzymes bacteria require to replicate, transcribe, repair, and recombine DNA.

Doctors may also prescribe Levaquin “off-label” to treat or prevent other bacterial infections, including tuberculosis (TB), Salmonella food poisoning, Shigella food poisoning, Campylobacter infections, and disseminated Mycobacterium avium complex disease, especially for people with a weakened immune system from HIV or other conditions.

Levaquin was first approved by the Food and Drug Administration (FDA) in 1996, and is produced by Janssen Pharmaceuticals, Inc, a subsidiary of Johnson & Johnson.

Levaquin and Tendon Issues

In 2008, the FDA required all fluoroquinolone manufacturers to include a black-box warning that the drug class can increase a person’s risk of tendonitis (tendon inflammation) and tendon rupture, a decision that came too late for a lot of people taking Levaquin, resulting in numerous lawsuits.

Plaintiffs charge that Johnson & Johnson should have strengthened their warnings about the potential tendon issues associated with Levaquin before the FDA issued its decree, and also that the company downplayed the drug’s risks to boost sales.

In 2010, Johnson & Johnson lost a court case against 87-year-old John Schedin, and had to pay nearly $2 million to Schedin for the damage he received to his Achilles tendon after taking Levaquin.

The company subsequently won several other court cases, in which plaintiffs failed to show the drug caused their tendon issues. To date, however, thousands more cases have reached settlements out of court.

The risk of tendonitis and tendon ruptures is greater for people over 60 years old, people taking corticosteroid drugs, and people with kidney, heart, or lung transplants.

Physical activity or exercise, kidney failure, and having previous tendon problems, such as rheumatoid arthritis, can also increase your risk of tendon issues while taking Levaquin.

Levaquin Warnings

You should not take Levaquin if you have a known sensitivity or allergy to levofloxacin and other quinolones (the family of antibiotics that encompasses fluoroquinolones).

You should also avoid the drug if you have the neuromuscular disease myasthenia gravis, as the drug could worsen your muscle weakness.

Some people experience other serious and sometimes life-threatening reactions from taking Levaquin, such as:

  • Dangerous skin disorders, including toxic epidermal necrolysis and Stevens- Johnson Syndrome
  • Blood vessel inflammation, joint pain, and muscle pain
  • Allergic pneumonitis, an inflammation of the walls of the lung’s air sacs
  • Interstitial nephritis (a kidney disorder) and kidney failure
  • Hepatitis (liver inflammation), jaundice (yellowing of the skin and eyes), liver cell death, and liver failure
  • Blood-related issues, including deficiencies in red blood cells or white blood cells

Pregnancy and Levaquin

It’s unknown if Levaquin can harm a developing fetus because no adequate and well-controlled studies have been carried out in pregnant women.

However, the drug’s antimicrobial benefits to the mother may outweigh the potential risks to her unborn child.

Levofloxacin is presumed to be present in breast milk, and the drug has the potential to cause serious side effects in infants.

Breastfeeding mothers taking Levaquin should either discontinue the drug or stop breastfeeding.

PMC

CASE HISTORY

A 50-year-old man, nonalcoholic, with uncontrolled diabetes mellitus and hypertension was admitted to the hospital with history of high-grade fever and cough with scanty expectoration, of 2 days’ duration; and burning micturition and ulcer over left foot. Clinically the patient was febrile and diagnosed to have community-acquired left lower lobe pneumonia with urinary tract infection and cellulites of left foot. Investigations revealed Hb was 10.4 g/dl, total leukocyte count was 9,500 cells/mm3 with neutrophilia, E.S.R. was 60 mm at one hour, random blood sugar was 250 mg/dl, blood urea was 25 mg/dl, serum creatinine was 1.3 mg/dl with normal creatinine clearance, and serum electrolytes were within normal limits. Peripheral smear for malarial parasite was negative. Urine microscopy showed 15-18 pus cells/high power field. However, urine culture was sterile and urine ketone bodies were negative. Blood and sputum culture did not grow any organisms. Final diagnosis of type 2 diabetes mellitus with hypertension with community-acquired pneumonia and urinary tract infection and cellulites of left foot with ulcer was made. In view of multiple infections, intravenous amoxicillin (1 g) and clavulanic acid (200 mg) every 8th hour were started and continued for 10 days. His general condition improved, and repeat chest x-ray showed resolution of pneumonia with better lung aeration. Cellulitis and urinary tract infection also showed improvement, and blood sugar and hypertension were under control. After 10 days, oral levofloxacin (500 mg/day) was started as a sequential therapy in view of persisting foot ulcer. On the third day of therapy, he became restless and speech became irrelevant and incoherent. Later he became abusive, violent and experienced visual hallucinations of people in his hospital room. Gradually his confusion worsened and he became more violent in nature. He slept very little. Psychiatric evaluation was suggestive of acute psychosis. The diagnosis of acute psychosis cannot be attributed to the clinical diagnosis as the patient had good improvement following 10 days of intravenous amoxicillin and clavulanic acid therapy. Other conditions like hypoglycemia, dyselectrolytemia, diabetic ketoacidosis, and meningitis were ruled out. Other drugs the patient was receiving were insulin, enalapril, atorvastatin, which are not known to result in such psychosis. So the likely possibility of levofloxacin-induced acute psychosis was considered and levofloxacin was stopped. Within 48 h of stopping levofloxacin, repeat psychiatric evaluation revealed him to be alert and oriented with no further hallucinations. His speech was normal in flow and content, and his concentration and recall were intact. He did not require any antipsychotic medications.

Precautions

Before taking levofloxacin, tell your doctor or pharmacist if you are allergic to it; or to other quinolone antibiotics (such as ciprofloxacin, moxifloxacin, ofloxacin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, joint/tendon problems (such as tendonitis, bursitis), kidney problems, mental/mood disorders (such as depression), a certain muscle condition (myasthenia gravis), nerve problems (such as peripheral neuropathy), seizure disorder, blood vessel problems (such as aneurysm or blockage of the aorta or other blood vessels, hardening of the arteries), high blood pressure, certain genetic conditions (Marfan syndrome, Ehlers-Danlos syndrome).

Levofloxacin may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using levofloxacin, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/”water pills”) or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using levofloxacin safely.

Levofloxacin may rarely cause serious changes in blood sugar, especially if you have diabetes. Check your blood sugar regularly as directed and share the results with your doctor. Watch for symptoms of high blood sugar such as increased thirst/urination. Also watch for symptoms of low blood sugar such as sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don’t have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or by drinking fruit juice or non-diet soda. Tell your doctor right away about the reaction and the use of this product. To help prevent low blood sugar, eat meals on a regular schedule, and no not skip meals. Your doctor may need to switch you to another antibiotic or adjust your diabetes medications if any reaction occurs.

This drug may make you dizzy or lightheaded. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.

Levofloxacin may cause live bacterial vaccines (such as typhoid vaccine) to not work as well. Do not have any immunizations/vaccinations while using this medication unless your doctor tells you to.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Children may be at greater risk for joint/tendon problems while using this drug. Discuss the risks and benefits with the doctor.

Older adults may be at greater risk for tendon problems (especially if they are also taking corticosteroids such as prednisone or hydrocortisone), QT prolongation, and a sudden tear/break in the main blood vessel (aorta).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This drug passes into breast milk in small amounts but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.

SIDE EFFECTS

Serious And Otherwise Important Adverse Reactions

The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling:

  • Disabling and Potentially Irreversible Serious Adverse Reactions
  • Tendinitis and Tendon Rupture
  • Peripheral Neuropathy
  • Central Nervous System Effects
  • Exacerbation of Myasthenia Gravis
  • Other Serious and Sometimes Fatal Reactions
  • Hypersensitivity Reactions
  • Hepatotoxicity
  • Clostridium difficile-Associated Diarrhea
  • Prolongation of the QT Interval
  • Musculoskeletal Disorders in Pediatric Patients
  • Blood Glucose Disturbances
  • Photosensitivity/Phototoxicity
  • Development of Drug Resistant Bacteria

Crystalluria and cylindruria have been reported with quinolones, including LEVAQUIN® . Therefore, adequate hydration of patients receiving LEVAQUIN® should be maintained to prevent the formation of a highly concentrated urine .

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data described below reflect exposure to LEVAQUIN® in 7537 patients in 29 pooled Phase 3 clinical trials. The population studied had a mean age of 50 years (approximately 74% of the population was < 65 years of age), 50% were male, 71% were Caucasian, 19% were Black. Patients were treated with LEVAQUIN® for a wide variety of infectious diseases . Patients received LEVAQUIN® doses of 750 mg once daily, 250 mg once daily, or 500 mg once or twice daily.

Treatment duration was usually 3–14 days, and the mean number of days on therapy was 10 days.

The overall incidence, type and distribution of adverse reactions was similar in patients receiving LEVAQUIN® doses of 750 mg once daily, 250 mg once daily, and 500 mg once or twice daily.

Adverse reactions occurring in ≥1% of LEVAQUIN® -treated patients and less common adverse reactions, occurring in 0.1 to <1% of LEVAQUIN® -treated patients, are shown in Table 4 and Table 5, respectively. The most common adverse drug reactions (≥3%) are nausea, headache, diarrhea, insomnia, constipation, and dizziness.

Table 4: Common (≥1%) Adverse Reactions Reported in Clinical Trials with LEVAQUIN®*

System/Organ Class Adverse Reaction %
(N=7537)
Infections and Infestations moniliasis 1
Psychiatric Disorders insomnia† 4
Nervous System Disorders headache 6
dizziness 3
Respiratory, Thoracic and Mediastinal Disorders dyspnea 1
Gastrointestinal Disorders nausea 7
diarrhea 5
constipation 3
abdominal pain 2
vomiting 2
dyspepsia 2
Skin and Subcutaneous Tissue Disorders rash 2
pruritus 1
Reproductive System and Breast Disorders vaginitis 1‡
General Disorders and Administration Site Conditions edema 1
injection site reaction 1
chest pain 1
*pool of studies included IV and oral administration
† N = 7274
‡ N = 3758 (women)

Table 5: Less Common (0.1 to 1%) Adverse Reactions Reported in Clinical Trials with LEVAQUIN® (N = 7537)

System/Organ Class Adverse Reaction
Infections and Infestations genital moniliasis
Blood and Lymphatic System Disorders anemia
thrombocytopenia
granulocytopenia
Immune System Disorders allergic reaction
Metabolism and Nutrition Disorders hyperglycemia
hypoglycemia

hyperkalemia

Psychiatric Disorders anxiety
agitation
confusion
depression
hallucination
nightmare *
sleep disorder *
anorexia
abnormal dreaming *
Nervous System Disorders tremor
convulsions

paresthesia
vertigo
hypertonia
hyperkinesias
abnormal gait somnolence *
somnolence
syncope

Respiratory, Thoracic and Mediastinal Disorders epistaxis
Cardiac Disorders cardiac arrest
palpitation
ventricular tachycardia
ventricular arrhythmia
Vascular Disorders phlebitis
Gastrointestinal Disorders gastritis
stomatitis
pancreatitis
esophagitis
gastroenteritis
glossitis
pseudomembranous/ C. difficile colitis
Hepatobiliary Disorders abnormal hepatic function increased hepatic enzymes increased alkaline phosphatase
Skin and Subcutaneous Tissue Disorders urticaria
Musculoskeletal and Connective Tissue Disorders arthralgia
tendinitis

myalgia
skeletal pain

Renal and Urinary Disorders abnormal renal function
acute renal failure
*N = 7274

In clinical trials using multiple-dose therapy, ophthalmologic abnormalities, including cataracts and multiple punctate lenticular opacities, have been noted in patients undergoing treatment with quinolones, including LEVAQUIN® . The relationship of the drugs to these events is not presently established.

Postmarketing Experience

Table 6 lists adverse reactions that have been identified during post-approval use of LEVAQUIN® . Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Table 6: Postmarketing Reports Of Adverse Drug Reactions

System/Organ Class Adverse Reaction
Blood and Lymphatic System Disorders pancytopenia
aplastic anemia
leukopenia
hemolytic anemia

eosinophilia

Immune System Disorders hypersensitivity reactions, sometimes fatal including:
anaphylactic/anaphylactoid reactions
anaphylactic shock
angioneurotic edema
serum sickness
Psychiatric Disorders psychosis
paranoia
isolated reports of suicidal ideation, suicide attempt and completed suicide
Nervous System Disorders exacerbation of myasthenia gravis
anosmia
ageusia
parosmia
dysgeusia
peripheral neuropathy (may be irreversible)
isolated reports of encephalopathy abnormal electroencephalogram (EEG)
dysphonia
pseudotumor cerebri
Eye Disorders uveitis
vision disturbance, including diplopia
visual acuity reduced
vision blurred
scotoma
Ear and Labyrinth Disorders hypoacusis
tinnitus
Cardiac Disorders isolated reports of torsade de pointes electrocardiogram QT prolonged tachycardia
Vascular Disorders vasodilatation
Respiratory, Thoracic and Mediastinal Disorders isolated reports of allergic pneumonitis
Hepatobiliary Disorders hepatic failure (including fatal cases)
hepatitis
jaundice
Skin and Subcutaneous Tissue Disorders bullous eruptions to include:
Stevens-Johnson Syndrome
toxic epidermal necrolysis
Acute Generalized Exanthematous Pustulosis (AGEP)
fixed drug eruptions
erythema multiforme

photosensitivity/phototoxicity reaction leukocytoclastic vasculitis

Musculoskeletal and Connective Tissue Disorders tendon rupture muscle injury, including rupture
rhabdomyolysis
Renal and Urinary Disorders interstitial nephritis
General Disorders and Administration Site Conditions multi-organ failure
pyrexia
Investigations prothrombin time prolonged international normalized ratio prolonged muscle enzymes increased

Read the entire FDA prescribing information for Levaquin (Levofloxacin)

This is a personal story about a recent interaction I had with the health care system and the pharmaceutical industry that caused me to reevaluate a lot of things.

The Friday before Thanksgiving, I realized I was sick. I had a bad cough, a sore throat, and my nose was totally stuffed-up. I was pretty miserable. I was like that for about a week, dosing up regularly on NyQuil and DayQuil. Things seemed to get a bit better—the sore throat calmed down and the stuffy feeling went away. But I was still coughing, so this Thursday, I went to the doctor. The doctor diagnosed bronchitis and prescribed an antibiotic.

Most cases of bronchitis are caused by viruses, not bacteria, and eventually go away on their own. Many doctors don’t think it’s worth prescribing antibiotics unless the infection persists beyond a few weeks. But about 10-15 percent of bronchitis cases are bacterial, so some doctors think it’s worth prescribing antibiotics in those cases—especially if the patient has asthma, which I do. So I went to CVS to pick up my prescription. It was $25. Now granted, my insurance isn’t that great, but antibiotics are usually like $10, so I was curious. It turned out I had been prescribed something called Levaquin, which I had never heard of. My doctor never explained her reasoning for prescribing the antibiotic, so I’m not sure why she picked this one, but I decided to read the drug information on the Metro on my way into work. It turns out that Levaquin comes with a big, top-of-the-drug-information warning that it may cause “tendon damage (e.g., tendinitis, tendon rupture) during or after treatment.” Apparently, your risk for such problems is greater if you are over 60, have had a kidney, heart, or lung transplant, or are taking one of a class of drugs known as corticosteroids.

I didn’t think much about the warning and took the first dose, as prescribed, around noon on Thursday. But at the end of the day, I decided to look more into the drug. (The phrase “tendon damage” was still on my mind, I guess, and I was probably subconsciously looking for an excuse to not go to the gym.) It turns out that the tendon damage described on the label involves a lot of older people having their Achilles’ tendon snap. Yeah. But there were also complaints about long-term muscle pain and tendon damage, even in younger people.

It turns out the original top-of-the-label warning about Levaquin and drugs like it (“fluoroquinolones,” including Cipro and Avelox) was the result of a lawsuit brought by the grassroots public service advocacy group Public Citizen. It was added in 2008 after a 12-year legal battle. Dr. Sidney Wolfe, the director of Public Citizen’s Health Research Group, told me that fluoroquinolones are still “hugely overprescribed” and said that they’re “rarely the first-choice drug for any infection.”

I really started sweating (literally) when I realized that I was taking a corticosteroid—one of the classes of drugs that are supposed to exacerbate the risk of tendon damage caused by Levaquin and drugs like it. You see, my doctor had also prescribed me Advair, an asthma medicine that combines a steroid with a long-acting version of the stuff that’s in the normal “rescue” inhalers that all ashmatics have. This freaked me out. My doctor, of course, must have known I was on the drug (my prescription records were right in front of her on the screen when we talked) and probably decided it was okay, given I’m young and healthy and all that. But the 47 pages of complaints on Topix and 29 pages on Medical News Today about side effects from the drug definitely worried me.

Eventually I talked myself off the ledge. I’m actually pretty trusting of authority, and I realize that there are probably tons of medicines with as many or more complaints about them on the internet. Also, since Levaquin is the 37th most-prescribed medicine in the US (accounting for significant portions of Johnson and Johnson’s pharmaceutical revenue), there must be lots of people who take it without noticing any short- or long-term side effects.

Still, the whole thing creeped me out. When my Achilles’ started aching while I was driving later that weekend, I decided to stop taking the drug. On Monday, I called my doctor. I told her I was having side effects, but I didn’t ask her why she prescribed Levaquin despite my being on Advair. I guess I was a bit deferential. But it’s hard to challenge someone who went to medical school based on some crap you read on the internet. Instead, I just told her about the side effects (I didn’t mention that they could be psychosomatic), and asked for a different antibiotic. She prescribed one.

Still, I can’t help but think about how this happened. Why did my doctor prescribe the medicine she did? Part of it, I suspect, is my fault: people go to the doctor expecting for the doctor to offer a solution. If she had just said there was nothing she could do, I might not have been satisfied. There’s a built-in bias to prescribe. Also, drug companies spend millions of dollars promoting their drugs. I don’t know why my doctor chose Levaquin over something else (it could just be that she decided this type of antibiotic would be more effective with bronchitis than others), but it could be that she came in contact with some of that marketing material and it subconsciously affected her decision.

What do you think?

Atypical (Walking) Pneumonia: Management and Treatment

How is walking pneumonia treated?

Walking pneumonia is usually mild, does not require hospitalization and is treated with antibiotics (if your doctor thinks bacteria is causing your symptoms). Several types of antibiotics are effective. Antibiotics that are used to treat walking pneumonia caused by Mycoplasma pneumoniae include:

  • Macrolide antibiotics: Macrolide drugs are the preferred treatment for children and adults. Macrolides include azithromycin (Zithromax®) and clarithromycin (Biaxin®). Over the past decade, some strains of Mycoplasma pneumoniae have become resistant to macrolide antibiotics, possibly due to the widespread use of azithromycin to treat various illnesses.
  • Fluoroquinolones: These drugs include ciprofloxacin (Cipro®) and levofloxacin (Levaquin®). Fluoroquinolones are not recommended for young children.
  • Tetracyclines: This group includes doxycycline and tetracycline. They are suitable for adults and older children.

Often, over-the-counter medications can also be taken to help relieve symptoms of nasal congestion, cough and loosen mucus buildup in the chest. If you have a fever:

  • Drink more fluids
  • Rest
  • Take medicine

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Failure of levofloxacin treatment in community-acquired pneumococcal pneumonia

  1. 1.

    Canton R, Morosini M, Enright MC, Morrissey I: Worldwide incidence, molecular epidemiology and mutations implicated in fluoroquinolone-resistant Streptococcus pneumoniae : data from the global PROTEKT surveillance programme. J Antimicrobial Chemother. 2003, 52: 944-952. 10.1093/jac/dkg465.

    • CAS
    • Article
    • Google Scholar
  2. 2.

    Brown SD, Farrell DJ, Morrissey I: Prevalence and molecular analysis of macrolide and fluoroquinolone resistance among isolates of Streptococcus pneumoniae collected during the 2000–2001 PROTEKT US Study. J Clin Microbiol. 2004, 42: 4980-4987. 10.1128/JCM.42.11.4980-4987.2004.

    • CAS
    • Article
    • PubMed
    • PubMed Central
    • Google Scholar
  3. 3.

    Reinert RR, Reinert S, van der Linden M, Cil MY, Al-Lahham A, Appelbaum P: Antimicrobial susceptibility of Streptococcus pneumoniae in eight European countries from 2001 to 2003. Antimicrob Agents Chemother. 2005, 49: 2903-2913. 10.1128/AAC.49.7.2903-2913.2005.

    • CAS
    • Article
    • PubMed
    • PubMed Central
    • Google Scholar
  4. 4.

    Mandell LA, Bartlett JG, Dowell SF, File TM, Musher DM, Whitney C: Update of practice guidelines for the management of community-acquired pneumonia in immunocompetent adults. Clin Infect Dis. 2003, 37: 1405-1433. 10.1086/380488.

    • Article
    • PubMed
    • Google Scholar
  5. 5.

    Gilbert DN, Moellering RC, Eliopoulos GM, Sande MA: The Sanford guide to antimicrobial therapy. 2005, Hyde Park, VT, USA, Thirty-fifth

    • Google Scholar
  6. 6.

    Eliopoulos GM: Quinolone resistance mechanisms in pneumococci. Clin Infect Dis. 2004, 350-356. 10.1086/382692. Suppl 4

  7. 7.

    Pletz MWR, McGee L, Jorgensen J, Beall B, Facklam RR, Whitney CG, Klugman KP, the Active Bacterial Core Surveillance Team: Levofloxacin-resistant invasive Streptococcus pneumoniae in the United States: evidence for clonal spread and the impact of conjugate pneumococcal vaccine. Antimicrob Agents Chemother. 2004, 48: 3491-3497. 10.1128/AAC.48.9.3491-3497.2004.

    • CAS
    • Article
    • PubMed
    • PubMed Central
    • Google Scholar
  8. 8.

    Goossens H, Ferech M, Vander Stichele R, Elseviers M, for the ESAC Project Group: Outpatient antibiotic use in Europe and association with resistance: a cross-national database study. Lancet. 2005, 365: 579-587.

    • Article
    • PubMed
    • Google Scholar
  9. 9.

    Pérez-Trallero E, Marimón JM, González A, Ercibengoa M, Larruskain J: In vivo development of high-level fluoroquinolone resistance in Streptococcus pneumoniae in chronic obstructive pulmonary disease. Clin Infect Dis. 2005, 41: 560-564. 10.1086/432062.

    • Article
    • PubMed
    • Google Scholar
  10. 10.

    Arbique JC, Poyart C, Trieu-Cuot P, Quesne G, da Glória S, Carvalho M, Steigerwalt AG, Morey RE, Jackson D, Davidson RJ, Facklam RR: Accuracy of phenotypic and genotypic testing for identification of Streptococcus pneumoniae and description of Streptococcus pseudopneumoniae sp. nov. J Clin Microbiol. 2004, 42: 4686-4696. 10.1128/JCM.42.10.4686-4696.2004.

    • CAS
    • Article
    • PubMed
    • PubMed Central
    • Google Scholar
  11. 11.

    Clinical and Laboratory Standards Institute: Performance standards for antimicrobial susceptibility testing. 2005, Supplement M100-S15

    • Google Scholar
  12. 12.

    Janoir C, Zeller V, Kitzis M-D, Moreau NJ, Gutmann L: High-level fluoroquinolone resistance in Streptococcus pneumoniae requires mutations in parC and gyrA. Antimicrob Agents Chemother. 1996, 40: 2760-2764.

    • CAS
    • PubMed
    • PubMed Central
    • Google Scholar
  13. 13.

    Perichon B, Tankovic J, Courvalin P: Characterization of a mutation in the parE gene that confers fluoroquinolone resistance in Streptococcus pneumoniae. Antimicrob Agents Chemother. 1997, 41: 1166-1167.

    • CAS
    • PubMed
    • PubMed Central
    • Google Scholar
  14. 14.

    Dagan R, Shriker O, Hazan I, Leibovitz E, Greenberg D, Schlaeffer F, Levy R: Prospective study to determined clinical relevance of detection of pneumococcal DNA in sera of children by PCR. J Clin Microbiol. 1998, 36: 669-673.

    • CAS
    • PubMed
    • PubMed Central
    • Google Scholar
  15. 15.

    Bast DJ, Low DE, Duncan CL, Kilburn L, Mandell LA, Davidson RJ, de Azavedo JCS: Fluoroquinolone resistance in clinical isolates of Streptococcus pneumoniae : contributions of type II topoisomerase mutations and efflux to levels of resistance. Antimicrob Agents Chemother. 2000, 44: 3049-3054. 10.1128/AAC.44.11.3049-3054.2000.

    • CAS
    • Article
    • PubMed
    • PubMed Central
    • Google Scholar
  16. 16.

    Davidson R, Cavalcanti R, Brunton JL, Bast DJ, de Azavedo JCS, Kibsey P, Fleming C, MLT , Low DE: Resistance to levofloxacin and failure of treatment of pneumococcal pneumonia. N Engl J Med. 2002, 346: 747-750. 10.1056/NEJMoa012122.

    • Article
    • PubMed
    • Google Scholar
  17. 17.

    Fuller JD, Low DE: A review of Streptococcus pneumoniae infection treatment failures associated with fluoroquinolone resistance. Clin Infect Dis. 2005, 41: 118-121. 10.1086/430829.

    • Article
    • PubMed
    • Google Scholar
  18. 18.

    Montanari MP, Tili E, Cochetti I, Mingoia M, Manzin A, Varaldo PE: Molecular characterization of clinical Streptococcus pneumoniae isolates with reduced susceptibility to fluoroquinolones emerging in Italy. Microb Drug Resist. 2004, 10: 209-217.

    • CAS
    • Article
    • PubMed
    • Google Scholar
  19. 19.

    Anderson KB, Tan JS, File TM, DiPersio JR, Willey BM, Low DE: Emergence of levofloxacin-resistant pneumococci in immunocompromised adults after therapy for community-acquired pneumonia. Clin Infect Dis. 2003, 37: 376-381. 10.1086/376642.

    • Article
    • PubMed
    • Google Scholar
  20. 20.

    Jones RN, Fritsche TR, Sader HS: Therapeutic options among broad-spectrum β-lactam for infections caused by levofloxacin-nonsusceptible Streptococcus pneumoniae. Diagn Microbiol Infect Dis. 2005, 52: 129-133. 10.1016/j.diagmicrobio.2004.12.009.

    • CAS
    • Article
    • PubMed
    • Google Scholar
  21. 21.

    Kollef MH: Optimizing antibiotic therapy in the intensive care unit setting. Critical Care. 2001, 5: 189-195. 10.1186/cc1022.

    • CAS
    • Article
    • PubMed
    • PubMed Central
    • Google Scholar
  22. 22.

    Graffunder EM, Preston KE, Evans AM, Venezia RA: Risk factors associated with extended-spectrum β-lactamase-producing organisms at a tertiary care hospital. J Antimicrob Chemother. 2005, 56: 139-145. 10.1093/jac/dki180.

    • CAS
    • Article
    • PubMed
    • Google Scholar

Pre-publication history

  1. The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2334/5/106/prepub

Drug maker stopped making popular antibiotic Levaquin amid concerns about mental health side effects

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.

As Call 6 Investigates reported this week, the U.S. Food and Drug Administration is requiring drug label changes for fluoroquinolone antibiotics sold under brand names like Levaquin, Cipro and Avelox.

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 McCarty died in 2013 after jumping out of a second story window and crashing his car into a cement embankment.

His mother, Heather McCarthy, said Shea was agitated and suffering mental health side effects from taking the antibiotic Levaquin.

RELATED | Mother blames antibiotic for son’s death | FDA announces antibiotic label changes following Call 6 report

Dr. 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. “It was hard for them to make money given the lawsuits they were facing.”

Patients sued Johnson & Johnson, accusing the company of hiding debilitating side effects of Levaquin for their own financial gain.

On September 11, 2014, Bennett filed a petition with the FDA calling on the federal agency to change the drug labels to better warn patients of the risks.

On July 10, 2018, the FDA responded with a safety announcement in which it called for label changes on fluoroquinolones including more prominent and consistent warnings for mental health side effects.

The mental health side effects, according to the FDA, include disturbances in attention, disorientation, agitation, nervousness, memory impairment, serious disturbances in mental abilities, and delirium.

Heather McCarthy told Call 6 Investigates Monday the FDA’s announcement is a breakthrough in acknowledging the drugs’ effects.

“While justice is slow – this label will now open the doors to accountability for doctors who chose to ignore patient complaints,” McCarthy said in an email to RTV6 Monday. “I personally believe there is a never a reason for doctors not to listen to patients and with this labeling, there is no longer a viable excuse to ignore patient complaints associated with fluoroquinolones. The key here is ending the degradation that patients must go through when they believe they have had an adverse effect from these drugs.”

Dr. Bennett called the FDA’s July 10 announcement a “huge paradigm shift.”

In 2016, the FDA announced an updated boxed warning and medication guide that advised serious side effects with fluoroquinolones generally outweigh the benefits for patients with sinusitis, bronchitis and uncomplicated urinary tract infections who have other treatment options.

Patients with those conditions should only use fluoroquinolones as a last resort, according to the FDA.

Fluoroquinolones are intended to treat major infections like pneumonia, anthrax exposure, plague and urinary tract infections.

Call 6 Investigates contacted Janssen, the maker of Levaquin, about the FDA’s July 10 announcement.

“At Janssen, our first priority is the well-being of the people who use our medicines. Janssen is reviewing the Safety Labeling Change Notification and working with the FDA to ensure labeling will be updated appropriately to facilitate the safe and appropriate use of LEVAQUIN®,” said Kelsey Buckholtz, Janssen spokesperson in a statement to RTV6. “LEVAQUIN® (levofloxacin) has been used for nearly 20 years to treat bacterial infections, including those that may be serious or life-threatening. LEVAQUIN® is part of the important fluoroquinolone class of anti-infective prescription medications, and its safety profile remains well-known and established.”

Call 6 Investigates also contacted Bayer, who makes Cipro and Avelox, about the FDA’s label change.

Bayer released the following statement:

“Fluoroquinolones, including Cipro® (ciprofloxacin) and Avelox® (moxifloxacin), are an important class of antibiotics that treat a range of bacterial infections, some of which are serious and can be life-threatening. Cipro has been used in more than 600 million patients worldwide since becoming available by prescription in 1987. Avelox has been used by more than 200 million patients since it became available in 1999.

FDA, on July 10, 2018, issued an announcement to reinforce safety information about the risks of low blood sugar levels and mental health side effects with fluoroquinolone antibiotics, and is requiring label changes for these products. This is a class-wide labeling change for all NDA and ANDA holders of fluoroquinolone antibiotics. Companies have 30 days to respond to the proposed label changes. Bayer is currently reviewing the proposed Labeling Change Notifications for Cipro and Avelox, and we will respond to the agency within the required time frame.

The current approved product labeling of both Cipro and Avelox reflects the benefit-risk profile of these drugs in their approved indications, including information about the risks of mental health side effects and hypoglycemia (low blood sugar).

Bayer’s highest priority is patient safety and we closely monitor the safety and efficacy of Cipro and Avelox on an ongoing basis. Bayer takes all reports of side effects very seriously, investigates them thoroughly, reports them to health authorities around the world as required and regularly evaluates whether the product’s benefit risk profile is adequately reflected in the product information.”

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