ANN ARBOR, Mich. — The U.S. Food and Drug Administration has required that all drugs using Azithromycin must have a warning label on them regarding the risk of abnormal changes to the electrical activity of the heart that in rare cases may lead to a fatal irregular heart beat rhythm.

MLive reported that the major drugs effected by this warning includes Zithromax and Z-Pak.

All Azithromycin labels now have strengthened warnings and precaution sections that identify those with QT interval prolongation, low bleed levels of potassium, a slower normal heart rate, or other heart medicine as susceptible to major heart complications.

Pfizer responded to the strengthened warning labels by issuing the following statement:

“A majority of patients treated with Zithromax are not affected by the label update. This potential risk is well established in macrolide antibiotics, as well as other antibiotics, such as quinolones.”

Figures as recently as 2012 indicate that Zithromax generates nearly $435 million in yearly revenue for Pfizer Inc.

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