Thursday, March 21, 2013

Risiko Aritmia Jantung pada Penggunaan Azithromicyn

Sekitar seminggu yang lalu, FDA mengeluarkan "warning statement" tentang Azithromycin, yang berbunyi sebagai berikut:

FDA is warning the public that azithromycin (Zithromax or Zmax) can cause abnormal changes in the electrical activity of the heart that may lead to a potentially fatal irregular heart rhythm. Patients at particular risk for developing this condition include those with known risk factors such as existing 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, or arrhythmias.  FDA has issued a Drug Safety Communication today as a result of our review of a study by medical researchers as well as another study by a manufacturer of the drug that assessed the potential for azithromycin to cause abnormal changes in the electrical activity of the heart.FDA previously released a Statement on May 17, 2012, about a study that compared the risks of cardiovascular death in patients treated with the antibacterial drugs azithromycin, amoxicillin, ciprofloxacin (Cipro), and levofloxacin (Levaquin), or no antibacterial drug. The study reported an increase in cardiovascular deaths, and in the risk of death from any cause, in persons treated with a 5-day course of azithromycin (Zithromax) compared to persons treated with amoxicillin, ciprofloxacin, or no drug. The risks of cardiovascular death associated with levofloxacin treatment were similar to those associated with azithromycin treatment.
Azythromycin merupakan antibiotik dengan berbagai indikasi, diantaranya: acute bacterial exacerbations of chronic obstructive pulmonary disease, acute bacterial sinusitis, community-acquired pneumonia, pharyngitis/tonsillitis, uncomplicated skin and skin structure infections, urethritis and cervicitis, genital ulcer diseaseDengan adanya warning dari FDA ini, Dokter dan Apoteker perlu mempertimbangkan kembali penggunaan Azithromycin pada pasien yang memiliki faktor risiko seperti:
  1. kondisi perpanjangan interval QT
  2. kadar kalium atau magnesium dalam darah yang rendah
  3. bradikardi
  4. penggunaan obat-obat aritmia atau obat-obatan yang mempengaruhi kadar kalium & magnesium
  5. memiliki riwayat aritmia
  6. memiliki risiko penyakit jantung lainnya
Tetapi Dokter atau Apoteker juga harus mengingat bahwa banyak antibiotik lain yang juga memiliki efek samping yang bermakna pada pasien dengan faktor risiko tertentu. Dalam hal ini, yang terpenting adalah mempertimbangkan rasio benefit vs risk dari penggunaan Azithromycin. 

Hope this update can help you! 

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