25 March 2013

Safety Reports For Medical Products

Reference: CIR-2013-SHN0088

Safety of pharmaceutical products containing the substance Azithromycin

With reference to the above mentioned subject, we would like to inform you that the American Food and Drug Association FDA has issued a warning about the usage of Azithromycin antibiotic, as it has caused abnormal changes in the electrical activity of the heart, which may lead to a lengthening QT interval resulting in irregular tachyarrhythmia, and it could be fatal leading to a risk factor of sudden death. And thus like most other antibiotics that belong to the antibiotics group of large molecules (Macrolides).


The patients who are most at risk are those who suffer from tachycardia (irregular heartbeats) as well as the low levels of potassium and magnesium in the blood. Also patients who are suffering from bradycardia, and those who are receiving medications for lengthening  QT interval, and those who suffer from other cardiac diseases.

We hence, recommend the following:

• All the health care practitioners should take the necessary precautions which are mentioned above when prescribing the drug Azithromycin and to use it within very limited scope of restrictions, as the alternative antibiotics either from the Macrolides group or from outside that group, such as antibiotics from a (Fluoroquinolones group) have also the same effect of lengthening the QT interval in addition to the other risks.

• Patients who use the above mentioned substance should not discontinue it and must keep follow up with their physicians.

In case of any side effects, please fill out the relevant form (Adverse Drug Reaction Form) or contact the pharmacy department.