On March 12, 2013, the
US-FDA Drug Safety Communication (DCS) announced that the integration
of additional information of new adverse drug reaction of
azithromycin should be added its label.
US FDA had evaluated that
azithromycin can potentially cause fatal heart arrhythmias. The drug
has shown that it prolongs the QT interval. Health care providers
should consider the risk of fatal heart arrhythmias with
azithromycin when prescribing antibacterial therapy for patients with
cardiovascular problems. Included in the consideration of
antibacterial therapy to cause fatal heart arrhythmias are those in
groups of other macrolides and fluoroquinolones.
The antibacterial action
of azithromycin is still favorable and beneficial even though
undesirable effect has found, but additional precaution and special
warnings should be considered with patients having:
- Congenital or documented QT prolongation.
- Receiving treatment with other active substances known to prolong QT interval such as antiarrhythmics of classess IA and III; antipsychotic agents; antidepressants; and fluoroquinolons.
- Electrolyte disturbance, particularly in cases of hypokalemia and hypomagnesemia.
- Clinically relevant bradycardia, cardiac arrhythmia or cardiac insufficiency
- Elderly patients who are susceptible to drug associated effects on the QT interval.
