Zithromax (azithromycin) FDA Drug Safety Communication

March 12, 2013

Patient safety is of the utmost importance to Pfizer and we continuously monitor the safety and efficacy of our products to ensure that the benefits and risks are accurately described in the product label, as approved by the FDA.

Pfizer, in collaboration with the US FDA, has updated the Zithromax (azithromycin) label with additional information regarding a specific, rare heart rhythm abnormality in patients with risk factors such as 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 ("arrhythmias"). It is important to note that other macrolide antibiotics are similarly labeled.

It is also important to note that the majority of patients treated with Zithromax (azithromycin) are not affected by this label update. This potential risk is well established in macrolide antibiotics, as well as other antibiotics, such as quinolones.

Zithromax (azithromycin) has had a well established benefit risk profile for more than twenty years and continues to be an effective treatment option for patients all over the globe suffering from many types of bacterial infections.

Patients who are currently prescribed Zithromax should talk to their doctors or healthcare providers if they have questions regarding their treatment.

For additional information on the current Zithromax label, patients and physicians can refer to the US FDA website at http://www.fda.gov/Drugs/DrugSafety/ucm341822.htm or contact Pfizer Medical Information at 1-800-438-1985.