SUMMARY:  

FDA released a drug safety advisory and follow-up review, advising caution before prescribing the antibiotic clarithromycin to patients with heart disease because of a potential increased risk of heart problems or death that can occur years later 

• A review of the results from the CLARICOR trial,  a 10-year follow-up study of patients with stable coronary heart disease from a large clinical trial, observed this serious safety issue 
• More deaths were observed in patients who underwent a two-week course of clarithromycin that became apparent after ≥1 year of follow up
  • No clear explanation was apparent as to why clarithromycin would lead to more deaths than placebo 
  • Observational studies have been conflicting   
• The FDA
  • Has added a new warning about this increased risk of death in patients with heart disease that also advises prescribers to consider using other antibiotics in such patients 
  • Has added the study results to the clarithromycin drug labels 
  • Will continue to monitor safety reports in patients taking clarithromycin 
• FDA recommends the following  

Healthcare professionals should be aware of these significant risks and weigh the benefits and risks of clarithromycin before prescribing it to any patient, particularly in patients with heart disease and even for short periods, and consider using other available antibiotics. Advise patients with heart disease of the signs and symptoms of cardiovascular problems, regardless of the medical condition for which you are treating them with clarithromycin.

KEY POINTS:  

• Clarithromycin is used to treat many types of infections including
  • Those affecting the skin, ears, sinuses and lungs   
  • Helicobacter pylori 
  • Mycobacterium avium complex (MAC) infection which can be seen in individuals with HIV  
• In the CLARICOR study, there was increased all-cause mortality and CVD during 10 year follow up, primarily in patients not on statin at entry 
• FDA recommends that patients talk to their provider about benefits and risks of clarithromycin and any alternative treatments 
• Patients should
  • Be alert to signs or symptoms of stroke or MI  
  • Should not stop taking medications without medical discussion and oversight  
• Adverse events or side effects should be reported to FDA’s MedWatch Safety Information and Adverse Event Reporting Program
  • Online: MedWatch Online Voluntary Reporting Form (fda.gov)
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 

Learn More – Primary Sources:  

FDA Drug Safety Communication: FDA review finds additional data supports the potential for increased long-term risks with antibiotic clarithromycin (Biaxin) in patients with heart disease

Clarithromycin for stable coronary heart disease increases all-cause and cardiovascular mortality and cerebrovascular morbidity over 10 years in the CLARICOR randomised, blinded clinical trial