Zithromax risk

[Guest guest]

____________________________________

Message 1

Date: 05/17/2012

Subject: FDA MedWatch - Zithromax (azithromycin): FDA Statement on risk of

cardiovascular death

Zithromax (azithromycin): FDA Statement on risk of cardiovascular death

Read the MedWatch safety alert, including a link to the Drug Safety

Communication at:

_http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMe

dicalProducts/ucm304503.htm_

(http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedica\

lProducts/ucm304503.htm?source=govdelivery)

Audience: Primary Care, Pharmacy

ISSUE: FDA notified healthcare professionals that it is aware of the study

published in the New England Journal of Medicine _ May 17, 2012_

(http://www.nejm.org/doi/full/10.1056/NEJMoa1003833?source=govdelivery)

reporting a

small 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.

FDA is reviewing the results from this study and will communicate any new

information on azithromycin and this study or the potential risk of QT

interval prolongation after the agency has completed its review.

BACKGROUND: Azithromycin belongs to a class of antibacterial drugs called

macrolides, which have been associated with cardiovascular effects;

specifically, prolongation of the QT interval. In 2011, FDA reviewed macrolide

drug labeling information related to QT interval prolongation and TdP. The

WARNINGS AND PRECAUTIONS section of the Zmax drug label (azithromycin extended

release for oral suspension) was revised in March 2012 to include new

information regarding risk for QT interval prolongation, which appears to be

low. The drug labels for clarithromycin and erythromycin also contain

information about QT interval prolongation in the WARNINGS section. FDA is in

the

process of updating risk information in the drug labels for additional

macrolide antibacterial drugs.

RECOMMENDATION: Patients taking azithromycin should not stop taking their

medicine without talking to their healthcare professional. Healthcare

professionals should be aware of the potential for QT interval prolongation and

heart arrhythmias when prescribing or administering macrolides.

Healthcare professionals and patients are encouraged to report adverse

events or side effects related to the use of these products to the FDA's

MedWatch Safety Information and Adverse Event Reporting Program:

* Complete and submit the report Online:

_www.fda.gov/MedWatch/report.htm_

(http://www.fda.gov/MedWatch/report.htm?source=govdelivery)

* _Download form_

(http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm?source\

=govdelivery) or call 1- to

request a reporting form, then complete and return to the address on the

pre-addressed form, or submit by fax to 1-800-FDA-0178

____________________________________

You are encouraged to report all serious adverse events and product

quality problems to FDA MedWatch at _www.fda.gov/medwatch/report.htm_

(http://www.fda.gov/medwatch/report.htm?source=govdelivery)

_Follow MedWatch on Twitter_

(http://twitter.com/FDAMedWatch?source=govdelivery)

Update your subscriptions, modify your e-mail address, or stop

subscriptions at any time on your _Subscriber Preferences Page_

(https://public.govdelivery.com/accounts/USFDA/subscriber/edit?preferences=true#\

tab1) . You will

need to use your e-mail address to log in. If you have questions or

problems with the subscription service, please contact

_support@..._

(mailto:support@...) .

This service is provided to you at no charge by _U.S. Food & Drug

Administration (FDA)_ (http://www.fda.gov/?source=govdelivery) .

(http://www.fda.gov/?source=govdelivery)

(http://www.hhs.gov/?source=govdelivery)

____________________________________

This email was sent to suncitycna@... using GovDelivery, on behalf of:

U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver

Spring, MD 20993 ·

(http://www.govdelivery.com/portals/powered-by?source=govdelivery)