Azithromycin

Question

Dear Doctors,
Yesterday I heard on the news that azithromycin antibiotics will be examined in America because it would be a dangerous drug. Do you know more about it? Because when I get a cure related to my CF, it is usually this antibiotic. (Also diane35® (hormone containing pill use in case of acne) and domperidone are going to be examined).

Answer

Dear reader,

We understand your concerns about the use of azithromycin.
Let me explain this problem more in detail.
Azithromycin belongs to the family of macrolide antibiotics, that have been in use for several years in the treatment of acute infections. But the last years, this antibiotic is being used more and more because of its anti-inflammatory properties. Major studies have shown that patients with CF and chronic infection with Pseudomonas have a slower decline in lung function when they use azithromycin as maintenance medication. Every drug has side effects. But you should know that each drug needs to pass high safety standards before it gets on the market. It is already known for a long time that the use of macrolide antibiotics is a risk for certain cardiac arrhythmias, which exceptionally can lead to death. Results from preclinical studies with azithromycin showed however that the risk with azithromycin was smaller than with other macrolides. In none of the major studies done in patients with CF, major safety issues were noticed.

However, a recent survey in more than 1 million people showed that adults who take azithromycin during 5 days for a respiratory infection, have a slightly higher risk of sudden death from cardiac arrhythmias than those who didn’t use antibiotics or who took amoxicillin. But there was no difference between those who took azitromycin and those who took levofloxacin (another antibiotic often used in CF). However, it is unclear whether the use of azithromycin is the cause, or whether the selection of patients plays a major role. Another large study showed that only the patients with underlying risk factors have an increased risk of sudden death. Based on those studies, the FDA (American Food and Drug Administration) decided to put out a 'security warning'. This doesn’t mean that the medicine suddenly cannot be used anymore. The FDA plans additional research to get more clarity.
At present, it is not recommended to combine azithromycin with other agents that may influence heart conductance, such as domperidone and grapefruit juice.
In case of doubt, an ECG can be done to detect underlying problems with the heart rhythm or conductance.

I hope this answer is clear enough.

Best regards,

Dr. Mieke Boon

15.05.2013