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[3-12-2013] The U.S. Food and Drug Administration (FDA) is warning the public that azithromycin (Zithromax or Zmax) can cause abnormal changes in the electrical activity of the heart that may lead to a potentially fatal irregular heart rhythm. Patients at particular risk for developing this condition include those with known risk factors such as existing QT interval prolongation, low blood levels of potassium or magnesium, a slower than normal heart rate, or use of certain drugs used to treat abnormal heart rhythms, or arrhythmias. This communication is a result of our review of a study by medical researchers as well as another study by a manufacturer of the drug that assessed the potential for azithromycin to cause abnormal changes in the electrical activity of the heart.
The azithromycin drug labels have been updated to strengthen the Warnings and Precautions section with information related to the risk of QT interval prolongation and torsades de pointes, a specific, rare heart rhythm abnormality. Information has also been added regarding the results of a clinical QT study which showed that azithromycin can prolong the QTc interval. (see Data Summary)
Health care professionals should consider the risk of fatal heart rhythms with azithromycin when considering treatment options for patients who are already at risk for cardiovascular events (see Additional Information for Health Care Professionals below). FDA notes that the potential risk of QT prolongation with azithromycin should be placed in appropriate context when choosing an antibacterial drug: Alternative drugs in the macrolide class, or non-macrolides such as the fluoroquinolones, also have the potential for QT prolongation or other significant side effects that should be considered when choosing an antibacterial drug.
FDA released a statement on May 17, 2012, about a New England Journal of Medicine (NEJM) study that compared the risks of cardiovascular death in patients treated with the antibacterial drugs azithromycin, amoxicillin, ciprofloxacin (Cipro), and levofloxacin (Levaquin), or no antibacterial drug.1 The study reported an increase in cardiovascular deaths, and in the risk of death from any cause, in persons treated with a 5-day course of azithromycin (Zithromax) compared to persons treated with amoxicillin, ciprofloxacin, or no drug. The risks of cardiovascular death associated with levofloxacin treatment were similar to those associated with azithromycin treatment.
The study published in NEJM suggested a higher risk of cardiovascular deaths and deaths from any cause in persons treated with a 5-day course of azithromycin compared to persons treated with amoxicillin, ciprofloxacin, or no drug.1
FDA also evaluated the results of a clinical QT study conducted by the manufacturer assessing the effects of azithromycin on the QT interval in adults. The results of the study indicated that azithromycin prolonged the QTc interval. Information regarding the results of the QT study has been added to the Zithromax drug label.
Based on review of recent evidence, CDC recommends a single 500 mg intramuscular dose of ceftriaxone for uncomplicated gonorrhea. Treatment for coinfection with Chlamydia trachomatis with oral doxycycline (100 mg twice daily for 7 days) should be administered when chlamydial infection has not been excluded.
In cases where gonococcal expedited partner therapy (provision of prescriptions or medications for the patient to take to a sex partner without the health care provider first examining the partner) is permissible by state law and the partner is unable or unlikely to seek timely treatment, the partner may be treated with a single 800 mg oral dose of cefixime, provided that concurrent chlamydial infection in the patient has been excluded. Otherwise, the partner may be treated with a single oral 800 mg cefixime dose plus oral doxycycline 100 mg twice daily for 7 days.
Cefixime 800 mg orally as a single dose. If treating with cefixime, and chlamydial infection has not been excluded, providers should treat for chlamydia with doxycycline 100 mg orally twice daily for 7 days. During pregnancy, azithromycin 1 g as a single dose is recommended to treat chlamydia.
A potential alternative to fluoroquinolones is azithromycin, although enteropathogens with decreased azithromycin susceptibility have been documented in several countries. Rifaximin has been approved to treat TD caused by noninvasive strains of E. coli. However, since it is often difficult for travelers to distinguish between invasive and noninvasive diarrhea, and since they would have to carry a backup drug in the event of invasive diarrhea, the overall usefulness of rifaximin as empiric self-treatment remains to be determined.
Children who accompany their parents on trips to high-risk destinations can contract TD as well, with elevated risk if they are visiting friends and family. Causative organisms include bacteria responsible for TD in adults, as well as viruses including norovirus and rotavirus. The main treatment for TD in children is ORS. Infants and younger children with TD are at higher risk for dehydration, which is best prevented by the early initiation of oral rehydration. Empiric antibiotic therapy should be considered if there is bloody or severe watery diarrhea or evidence of systemic infection. In older children and teenagers, treatment recommendations for TD follow those for adults, with possible adjustments in the dose of medication. Among younger children, macrolides such as azithromycin are considered first-line antibiotic therapy, although some experts now use short-course fluoroquinolone therapy (despite its not being FDA-approved for this indication in children) for travelers aged
1 Antibiotic regimens may be combined with loperamide 4 mg initially followed by 2 mg after each loose stool, not to exceed 16 mg in a 24-hour period. 2 Use empirically as first-line in Southeast Asia or other areas if fluoroquinolone-resistant bacteria are suspected. 3 Preferred regimen for dysentery or febrile diarrhea. 4 If symptoms are not resolved after 24 hours, continue daily dosing for up to 3 days. 5 Do not use if clinical suspicion for Campylobacter, Salmonella, Shigella, or other causes of invasive diarrhea. Use may be reserved for patients unable to receive fluoroquinolones or azithromycin.
Single-dose azithromycin is recommended over multi-dose doxycycline as treatment for chlamydial infection. However, even with imperfect adherence, doxycycline is more effective in treating genital and rectal infection. Recently, it has been suggested that autoinoculation from the rectum to the genitals may be a source of persistent chlamydial infection in women. We estimated the impact autoinoculation may have on azithromycin and doxycycline effectiveness.
We estimate treatment effectiveness using a simple mathematical model, incorporating data on azithromycin and doxycycline efficacy from recent meta-analyses, and data on prevalence of rectal infection in women with genital chlamydial infection.
Single-dose azithromycin has been recommended over a week-long doxycycline course as treatment for genital chlamydial infection, primarily because of concern about lack of adherence for the longer doxycycline course. However, the assumed superiority of azithromycin has been questioned . In 2002, a meta-analysis concluded that azithromycin and doxycycline were equally efficacious in treating urogenital chlamydial infection (with efficacies of 97% and 98% respectively) , but a 2014 meta-analysis found a greater disparity, with efficacies of 94.3% for azithromycin and 97.1% for doxycycline . For rectal infection, the difference may be greater: another systematic review estimated treatment efficacies of 82.9% for azithromycin and 99.6% for doxycycline , with different delivery mechanisms being suggested as a possible reason for the difference . Additionally, background use of tetracyclines but not macrolides has been found to be associated with lower chlamydia prevalence .
It has recently been proposed that autoinoculation (the inoculation of a site with infective bodies from another site on the same individual) of chlamydia from the gastrointestinal (GI) tract to the genital tract is possible in women, and that the GI tract may be a niche for persistent infection [7-9]. Mice orally infected with chlamydia develop genital infections , similar to Escherichia coli urinary tract infections that occur in women as a result of faecal contamination, and rectal-vaginal autoinoculation is suspected to occur in infants . It is at least theoretically possible, if not likely, that chlamydiae in the GI tract that have survived treatment with antibiotics may re-infect the genital tract in humans. Persistent infection or repeat infections in women are very common, with estimates of up to 29.9% among women reported , and are of concern because of the increased risk of pelvic inflammatory disease with repeat infection. If there is a substantial difference in the efficacy of doxycycline and azithromycin in resolving GI/rectal infection, and autoinoculation is a possibility, this may be further cause for reconsidering azithromycin as the preferred treatment for genital chlamydial infection.
We perform a simple calculation to estimate the probability that a woman with a genital chlamydial infection, treated with either azithromycin or doxycycline, remains chlamydia-free when the possibility of autoinoculation is considered. At present there are no estimates of the probability of autoinoculation from rectum to genital tract, so we consider the full range of probabilities from zero (autoinoculation never occurs) to one (autoinoculation always occurs). We consider two scenarios: the case of a woman known to be genitally infected but who has not been tested for rectal infection (as is usual practice), and the case of a woman known to have both genital and rectal infection. 59ce067264