Any person who has ever visited a doctor’s office is likely to have taken a course of azithromycin, an antibiotic also commonly known as Zithromax or Z-Pak. Azithromycin belongs to a group of antibiotics called macrolides and is used to treat respiratory, throat, ear, and other infections. According to data from a 2011 IMX Health report, approximately 40 million individuals, in the outpatient setting, received prescriptions for azithromycin that year--making it the most commonly prescribed, some might even say over-prescribed, antibiotic in the United States. This phenomenon was partly driven by the drugs popularity among patients for its clever packaging, convenient 5-day course, and catchy name. The carefree days of prescribing azithromycin came to a screeching halt in 2012 when an observational study, published in the New England Journal of Medicine (NEJM) (1), concluded that people who took the antibiotic had an increased incidence of sudden cardiac death and all-cause mortality, compared with individuals who took other antibiotics or took nothing. The adverse events only occurred during the 5-day treatment course, suggesting that the risk dissipated as the drug cleared from the body on subsequent days. Prior to that, the FDA had been monitoring post-marketing surveillance that suggested that macrolide antibiotics were associated with QT-interval prolongation, a change in heart rhythm that can potentially lead to a life-threatening condition called . Following the 2012 NEJM publication, the FDA issued a safety report to the public and prompted the manufacturer to include a warning label to prescribers. Azithromycin is one of the most commonly prescribed antibiotics on the market. Millions of doses have been administered to patients dealing with bacterial infections such as bronchitis and pneumonia, as well as infections of the ears, lungs, and other organs. In the past couple of years, the drug has come under some scrutiny. The Food and Drug Administration announced in 2013 that azithromycin can cause a potentially fatal disturbance in a person’s heart rhythm. These two points are very important to remember: In patients with heart disease, though, azithromycin and other macrolide antibiotics – such as clarithromycin, erythromycin, and telithromycin – can speed up the heart so that it beats very fast, up to 200 times per minute. When the heart is beating that fast, its pumping action is greatly diminished – it can’t take in blood and pump it out correctly. As a result, blood pressure drops and a loss of consciousness becomes a risk. If a person experiences these symptoms while driving, a crash could easily happen. Worse still, if the condition isn’t treated, the heart could stop pumping altogether. Without rapid treatment – for example, applying an electrical impulse with a defibrillator – the patient could die.
The Danish Study The Danish study did not find an increased risk of cardiovascular death associated with azithromycin. The study results pointed to an increased risk among patients with a history of cardiovascular disease, and no significant differences were observed in comparison with patients who did not have that history. This was a retrospective study involving Danish adults ages 18-64, linking registry data on filled prescriptions, causes of death and medical histories for the period 1997-2010. The investigators estimated rate ratios for death from cardiovascular causes, comparing 1,102,050 episodes of azithromycin use with no use of antibiotic agents and comparing 1,102,419 episodes of azithromycin use with 7,364,292 episodes of use of penicillin V, an antibiotic with similar indications. The risk of death from cardiovascular causes was significantly increased with current use of azithromycin (defined as a 5-day treatment episode), as compared with no use of antibiotics. The analysis relative to an antibiotic comparator included 17 deaths from cardiovascular causes during azithromycin use (1.1 deaths per 1,000 person-years) and 146 during penicillin V use (1.5 deaths per 1,000 person-years). As compared with penicillin V, azithromycin was not associated with a significantly increased risk of cardiovascular death, indicating that the increased risk that was observed in comparison with no antibiotic use was attributable to the risk of death associated with acute infection. If you subscribe to any of our print newsletters and have never activated your online account, please activate your account below for online access. By activating your account, you will create a login and password.
May 16, 2012. May 16, 2012 -- Sudden heart death may be a new risk from the commonly prescribed antibiotic azithromycin -- better known as Zithromax or. There were 29 heart-related deaths among those who took azithromycin during 5 days of treatment. Their risk of death while taking the drug was almost triple.