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1、FDAFDA DrugDrug SafetySafety Communication:Communication: AzithromycinAzithromycin (Zithromax(Zithromax oror Zmax)Zmax) andand thethe riskrisk ofof potentiallypotentially fatalfatal heartheart rhythmsrhythms SafetySafety AnnouncementAnnouncement3-12-20133-12-2013 The U.S. Food and Drug Administratio
2、n (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
3、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 m
4、anufacturer 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 an
5、d 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)HealthHealth carecare professionalsprofessionals shouldshould considerconsider
6、 thethe riskrisk ofof fatalfatal heartheart rhythmsrhythms withwith azithromycinazithromycin whenwhen consideringconsidering treatmenttreatment optionsoptions forfor patientspatients whowho areare alreadyalready atat riskrisk forfor cardiovascularcardiovascular eventsevents (see(see AdditionalAdditi
7、onal InformationInformation forfor HealthHealth CareCare ProfessionalsProfessionals below).below). FDAFDA notesnotes thatthat thethe potentialpotential riskrisk ofof QTQT prolongationprolongation withwith azithromycinazithromycin shouldshould bebe placedplaced inin appropriateappropriate contextcont
8、ext whenwhen choosingchoosing anan antibacterialantibacterial drug:drug: AlternativeAlternative drugsdrugs inin thethe macrolidemacrolide class,class, oror non-macrolidesnon-macrolides suchsuch asas thethe fluoroquinolones,fluoroquinolones, alsoalso havehave thethe potentialpotential forfor QTQT pro
9、longationprolongation oror otherother significantsignificant sideside effectseffects thatthat shouldshould bebe consideredconsidered whenwhen choosingchoosing anan antibacterialantibacterial drug.drug.FDA released a statement on May 17, 2012, about a NewNew EnglandEngland JournalJournal ofof Medicin
10、eMedicine (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 o
11、f 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. F
12、DA will update health care professionals and the public with any relevant information that becomes available about azithromycin and the risk of abnormal heart rhythms.DataData SummarySummaryThe study published in NEJM suggested a higher risk of cardiovascular deaths and deaths from any cause in pers
13、ons treated with a 5-day course of azithromycin compared to persons treated with amoxicillin, ciprofloxacin, or no drug.1The study has important limitations. First, patients were not randomized to the antibacterial drugs studied, so patients who received different drugs might have differed in ways t
14、hat could have biased the results. Second, the study only examined antibacterial drugs used in an outpatient setting, so it is likely that few patients were being treated for severe or life-threatening infections. Third, cardiovascular deaths were determined using death certificates rather than full
15、 medical records. Fourth, there were also some limitations to the statistical methods used.On balance, however, the study was methodologically sound and supports the validity of the overall finding. The estimated excess risk of cardiovascular death compared with amoxicillin varied considerably with
16、the patients baseline cardiovascular risk, from roughly 1 in 111,000 among healthier patients to 1 in 4,100 among high-risk patients. The duration of the elevated risk of all-cause mortality and of cardiovascular death corresponded to the duration of azithromycin therapy. The increase in total deaths was due to cardiovascular deaths and not due to an increase in deaths from
