YIJOM-2998; No of Pages 1
Int. J. Oral Maxillofac. Surg. 2014; xxx: xxx–xxx http://dx.doi.org/10.1016/j.ijom.2014.09.016, available online at http://www.sciencedirect.com
Letter to the Editor Azithromycin and congenital heart disease Dear Editor, In March 2013, the US Food and Drug Administration (FDA) issued a Drug Safety Communication warning related to azithromycin and the potential of causing abnormal changes in cardiac electrical activity which may lead to lethal cardiac arrhythmias. The risk of torsades de pointes and fatal arrhythmia could develop during treatment with azithromycin in a certain group of patients at higher risk. These higher risk patients include those with a prolonged QT interval, history of torsades de pointes, congenital long QT syndrome, and bradyarrhythmias.1 The FDA warning was based on a study by Ray et al. comparing the cardiovascular death risk in patients treated with azithromycin, amoxicillin, ciprofloxacin, and levofloxacin, or without an antibacterial drug.2 The American Heart Association (AHA) 2007 guidelines on antibiotic prophylaxis of infective endocarditis (IE) before surgical dental procedures recommend azithromycin as an alternative antimicrobial in patients requiring antibiotic prophylaxis who are allergic to penicillin or ampicillin and who are able to take medication orally. The patients indicated for prophylactic antibiotic use are those with completely repaired congenital heart disease (CHD) with a prosthetic material or device during the first 6 months after the surgical repair, and patients with unrepaired cyanotic CHD, including those with palliative shunts and conduits.3 It is noteworthy and of clinical significance that bradyarrhythmias may occur in some CHD cases requiring antibiotic prophylaxis against IE. These bradyarrhythmias include sinus node dysfunction, 0901-5027/000001+01
which is a common problem in patients who have undergone surgical repair of CHD using the Mustard procedure (which is used to repair transposition of the great arteries (D-type) with a synthetic baffle), and the Fontan procedure (which is used to repair tricuspid atresia with a synthetic conduit). Furthermore, an acquired atrio-ventricular block can develop in patients with repaired tetralogy of Fallot causing bradyarrhythmias. Also the repaired tetralogy of Fallot surgical procedure includes a synthetic conduit.4–6 Our concern regards the use of azithromycin as a prophylactic antibiotic in the first 6 months in the above-mentioned surgical repairs, as it may lead to fatal arrhythmias. The AHA guidelines should be revised to include this warning, or an alternative antibiotic replacing azithromycin should be added. Funding
None. Competing interests
None. Ethical approval
None. Patient consent
Not required.
F.B. Rihani* Paediatric Dentistry, Prince Rashid Bin Al-Hassan Hospital, Royal Medical Services, Jordan
*Address: Farouk B. Rihani, Irbid, Al-Huson, Postal Code 21510, PO Box 434, Jordan. Tel: +962 777688920; Fax: +962 65937076. E-mail address: [email protected] (F.B. Rihani) Accepted 18 September 2014 References 1. FDA Drug Safety Communication Azithromycin and risk of potentially fatal heart rhythms. FDA; 2013. Available at: http://www.fda.gov/ Drugs/DrugSafety/ucm341822.htm (accessed 31 May 2014). 2. Ray WA, Murray KT, Hall K, Arbogast PG, Stein CM. Azithromycin and the risk of cardiovascular death. N Engl J Med 2012;366: 1881–90. 3. Wilson W, Taubert KA, Gewitz M, Lockhart PB, Baddour LM, Levison M, et al. Prevention of infective endocarditis: guidelines from the American Heart Association: a guideline from the American Heart Association Rheumatic Fever, Endocarditis, and Kawasaki Disease Committee, Council on Cardiovascular Disease in the Young, and the Council on Clinical Cardiology, Council on Cardiovascular Surgery and Anesthesia, and the Quality of Care and Outcomes Research Interdisciplinary Working Group. Circulation 2007;116:1736–54. 4. Fishberger SB. Sinus node dysfunction. In: Walsh EP, Saul JP, Triedman JK, editors. Cardiac arrhythmias in children and young adults with congenital heart disease. Philadelphia: Lippincott Williams & Wilkins; 2001 . p. 271–83. 5. Walsh EP. Arrhythmias in patients with congenital heart disease. Card Electrophysiol Rev 2002;6:422–30. 6. Heiden K. Congenital heart defects, simplified. Wisconsin: Midwest EchoSolutions; 2009: 53–65.
# 2014 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.
Please cite this article in press as: Rihani FB. Azithromycin and congenital heart disease, Int J Oral Maxillofac Surg (2014), http:// dx.doi.org/10.1016/j.ijom.2014.09.016
Int. J. Oral Maxillofac. Surg. 2014; xxx: xxx–xxx http://dx.doi.org/10.1016/j.ijom.2014.09.016, available online at http://www.sciencedirect.com
Letter to the Editor Azithromycin and congenital heart disease Dear Editor, In March 2013, the US Food and Drug Administration (FDA) issued a Drug Safety Communication warning related to azithromycin and the potential of causing abnormal changes in cardiac electrical activity which may lead to lethal cardiac arrhythmias. The risk of torsades de pointes and fatal arrhythmia could develop during treatment with azithromycin in a certain group of patients at higher risk. These higher risk patients include those with a prolonged QT interval, history of torsades de pointes, congenital long QT syndrome, and bradyarrhythmias.1 The FDA warning was based on a study by Ray et al. comparing the cardiovascular death risk in patients treated with azithromycin, amoxicillin, ciprofloxacin, and levofloxacin, or without an antibacterial drug.2 The American Heart Association (AHA) 2007 guidelines on antibiotic prophylaxis of infective endocarditis (IE) before surgical dental procedures recommend azithromycin as an alternative antimicrobial in patients requiring antibiotic prophylaxis who are allergic to penicillin or ampicillin and who are able to take medication orally. The patients indicated for prophylactic antibiotic use are those with completely repaired congenital heart disease (CHD) with a prosthetic material or device during the first 6 months after the surgical repair, and patients with unrepaired cyanotic CHD, including those with palliative shunts and conduits.3 It is noteworthy and of clinical significance that bradyarrhythmias may occur in some CHD cases requiring antibiotic prophylaxis against IE. These bradyarrhythmias include sinus node dysfunction, 0901-5027/000001+01
which is a common problem in patients who have undergone surgical repair of CHD using the Mustard procedure (which is used to repair transposition of the great arteries (D-type) with a synthetic baffle), and the Fontan procedure (which is used to repair tricuspid atresia with a synthetic conduit). Furthermore, an acquired atrio-ventricular block can develop in patients with repaired tetralogy of Fallot causing bradyarrhythmias. Also the repaired tetralogy of Fallot surgical procedure includes a synthetic conduit.4–6 Our concern regards the use of azithromycin as a prophylactic antibiotic in the first 6 months in the above-mentioned surgical repairs, as it may lead to fatal arrhythmias. The AHA guidelines should be revised to include this warning, or an alternative antibiotic replacing azithromycin should be added. Funding
None. Competing interests
None. Ethical approval
None. Patient consent
Not required.
F.B. Rihani* Paediatric Dentistry, Prince Rashid Bin Al-Hassan Hospital, Royal Medical Services, Jordan
*Address: Farouk B. Rihani, Irbid, Al-Huson, Postal Code 21510, PO Box 434, Jordan. Tel: +962 777688920; Fax: +962 65937076. E-mail address: [email protected] (F.B. Rihani) Accepted 18 September 2014 References 1. FDA Drug Safety Communication Azithromycin and risk of potentially fatal heart rhythms. FDA; 2013. Available at: http://www.fda.gov/ Drugs/DrugSafety/ucm341822.htm (accessed 31 May 2014). 2. Ray WA, Murray KT, Hall K, Arbogast PG, Stein CM. Azithromycin and the risk of cardiovascular death. N Engl J Med 2012;366: 1881–90. 3. Wilson W, Taubert KA, Gewitz M, Lockhart PB, Baddour LM, Levison M, et al. Prevention of infective endocarditis: guidelines from the American Heart Association: a guideline from the American Heart Association Rheumatic Fever, Endocarditis, and Kawasaki Disease Committee, Council on Cardiovascular Disease in the Young, and the Council on Clinical Cardiology, Council on Cardiovascular Surgery and Anesthesia, and the Quality of Care and Outcomes Research Interdisciplinary Working Group. Circulation 2007;116:1736–54. 4. Fishberger SB. Sinus node dysfunction. In: Walsh EP, Saul JP, Triedman JK, editors. Cardiac arrhythmias in children and young adults with congenital heart disease. Philadelphia: Lippincott Williams & Wilkins; 2001 . p. 271–83. 5. Walsh EP. Arrhythmias in patients with congenital heart disease. Card Electrophysiol Rev 2002;6:422–30. 6. Heiden K. Congenital heart defects, simplified. Wisconsin: Midwest EchoSolutions; 2009: 53–65.
# 2014 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.
Please cite this article in press as: Rihani FB. Azithromycin and congenital heart disease, Int J Oral Maxillofac Surg (2014), http:// dx.doi.org/10.1016/j.ijom.2014.09.016
