Posted today on Medpage Today: FDA Warns of Arrhythmias with Azithromycin By John Gever, Senior Editor, MedPage Today Published: March 12, 2013 SILVER SPRING, Md. -- Patients with certain risk factors may be subject to life-threatening cardiac arrhythmias when taking azithromycin (Zithromax, Zmax), the FDA said Tuesday. Existing QT prolongation, bradycardia, and low blood levels of magnesium or potassium are among the risk factors associated with the threat, according to an FDA drug safety communication posted on the agency's website. In such patients, the drug may exacerbate QT prolongation and lead to torsades de pointes, a potentially lethal form of arrhythmia. The warning resulted from a data review begun last year after researchers reported a higher risk of cardiovascular death in patients taking azithromycin versus amoxicillin or no antibiotics. Following the publication of that study in the New England Journal of Medicine last May, the FDA promised to investigate the findings. In its Tuesday announcement, the FDA said it was strengthening the warnings-and-precautions section of the drug's label to highlight the risk of QT prolongation and torsades de pointes. It indicated that, although the NEJM study had limitations, such as relying on death certificates for identifying a cardiovascular cause of death, "on balance ... the study was methodologically sound and supports the validity of the overall finding." In the study, the risk of cardiovascular death was 1 in 4,100 among high-risk patients and the duration of increased risk corresponded to the duration of azithromycin exposure. The FDA advised healthcare professionals to "consider the risk of fatal heart rhythms with azithromycin when considering treatment options for patients who are already at risk for cardiovascular events." It also noted that some alternative antibiotics in the macrolide class (which includes azithromycin) as well as fluoroquinolones "also have the potential for QT prolongation or other significant side effects that should be considered when choosing an antibacterial drug." Doreen https://www.afibbers.org/forum/read.php?9,137071,137071#msg-137071 Sat, 06 Jun 2026 15:25:50 +0000 Phorum 5.2.23 https://www.afibbers.org/forum/read.php?9,137071,137136#msg-137136 https://www.afibbers.org/forum/read.php?9,137071,137136#msg-137136 dwightsbride AFIBBERS FORUM Sun, 17 Mar 2013 21:30:10 +0000 https://www.afibbers.org/forum/read.php?9,137071,137086#msg-137086 https://www.afibbers.org/forum/read.php?9,137071,137086#msg-137086
Existing QT prolongation, bradycardia, and low blood levels of magnesium or potassium are among the risk factors associated with the threat, according to an FDA drug safety communication posted on the agency's website.

And yet, most doctors will dismiss a potassium/magnesium connection.]]> Doreen AFIBBERS FORUM Wed, 13 Mar 2013 19:29:13 +0000 https://www.afibbers.org/forum/read.php?9,137071,137082#msg-137082 https://www.afibbers.org/forum/read.php?9,137071,137082#msg-137082 lisa s AFIBBERS FORUM Wed, 13 Mar 2013 14:03:47 +0000 https://www.afibbers.org/forum/read.php?9,137071,137080#msg-137080 https://www.afibbers.org/forum/read.php?9,137071,137080#msg-137080 -------------------------------------------------------
> Doreen, is there a link to the article?
>
> thanks,
>
> lisa

Sorry Lisa,

I was away from the computer. Try this.

Doreen

[www.medpagetoday.com]]]> Doreen AFIBBERS FORUM Wed, 13 Mar 2013 13:57:48 +0000 https://www.afibbers.org/forum/read.php?9,137071,137077#msg-137077 https://www.afibbers.org/forum/read.php?9,137071,137077#msg-137077 PeggyM]]> Anonymous User AFIBBERS FORUM Wed, 13 Mar 2013 09:09:38 +0000 https://www.afibbers.org/forum/read.php?9,137071,137075#msg-137075 https://www.afibbers.org/forum/read.php?9,137071,137075#msg-137075
Nancy]]> Nancy AFIBBERS FORUM Wed, 13 Mar 2013 00:23:48 +0000 https://www.afibbers.org/forum/read.php?9,137071,137074#msg-137074 https://www.afibbers.org/forum/read.php?9,137071,137074#msg-137074
To P]]> Poppino AFIBBERS FORUM Tue, 12 Mar 2013 23:19:37 +0000 https://www.afibbers.org/forum/read.php?9,137071,137073#msg-137073 https://www.afibbers.org/forum/read.php?9,137071,137073#msg-137073
thanks,

lisa]]> lisa s AFIBBERS FORUM Tue, 12 Mar 2013 23:10:49 +0000 https://www.afibbers.org/forum/read.php?9,137071,137071#msg-137071 https://www.afibbers.org/forum/read.php?9,137071,137071#msg-137071

FDA Warns of Arrhythmias with Azithromycin

By John Gever, Senior Editor, MedPage Today
Published: March 12, 2013


SILVER SPRING, Md. -- Patients with certain risk factors may be subject to life-threatening cardiac arrhythmias when taking azithromycin (Zithromax, Zmax), the FDA said Tuesday.

Existing QT prolongation, bradycardia, and low blood levels of magnesium or potassium are among the risk factors associated with the threat, according to an FDA drug safety communication posted on the agency's website.

In such patients, the drug may exacerbate QT prolongation and lead to torsades de pointes, a potentially lethal form of arrhythmia.

The warning resulted from a data review begun last year after researchers reported a higher risk of cardiovascular death in patients taking azithromycin versus amoxicillin or no antibiotics. Following the publication of that study in the New England Journal of Medicine last May, the FDA promised to investigate the findings.

In its Tuesday announcement, the FDA said it was strengthening the warnings-and-precautions section of the drug's label to highlight the risk of QT prolongation and torsades de pointes.

It indicated that, although the NEJM study had limitations, such as relying on death certificates for identifying a cardiovascular cause of death, "on balance ... the study was methodologically sound and supports the validity of the overall finding."

In the study, the risk of cardiovascular death was 1 in 4,100 among high-risk patients and the duration of increased risk corresponded to the duration of azithromycin exposure.

The FDA advised healthcare professionals to "consider the risk of fatal heart rhythms with azithromycin when considering treatment options for patients who are already at risk for cardiovascular events."

It also noted that some alternative antibiotics in the macrolide class (which includes azithromycin) as well as fluoroquinolones "also have the potential for QT prolongation or other significant side effects that should be considered when choosing an antibacterial drug."


Doreen]]> Doreen AFIBBERS FORUM Tue, 12 Mar 2013 22:28:47 +0000