Other safety alerts
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| The United States: Clarithromycin (Biaxin): Drug Safety Communication - Potential increased risk of heart problems or death in patients with heart disease |
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The US Food and Drug Administration (FDA) is advising caution before prescribing the antibiotic clarithromycin (Biaxin) to patients with heart disease because of a potential increased risk of heart problems or death that can occur years later. FDA’s recommendation is based on a review of the results of a 10-year follow-up study of patients with coronary heart disease from a large clinical trial that first observed this safety issue.
The large clinical trial, called the CLARICOR trial, observed an unexpected increase in deaths among patients with coronary heart disease who received a two-week course of clarithromycin that became apparent after patients had been followed for one year or longer. There is no clear explanation for how clarithromycin would lead to more deaths than placebo. Some observational studies also found an increase in deaths or other serious heart-related problems, while others did not. All the studies had limitations in how they were designed. Of the six observational studies published to date in patients with or without coronary artery disease, two found evidence of long-term risks from clarithromycin, and four did not. Overall, results from the prospective, placebo-controlled CLARICOR trial provide the strongest evidence of the increase in risk compared to the observational study results. Based on these studies, FDA is unable to determine why the risk of death is greater for patients with heart disease.
As a result, FDA added a new warning about this increased risk of death in patients with heart disease, and advised prescribers to consider using other antibiotics in such patients. FDA also added the study results to the clarithromycin drug labels. As part of FDA’s usual ongoing safety monitoring of drugs, FDA is continuing to monitor safety reports in patients taking clarithromycin.
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. Healthcare professionals should also advise patients with heart disease of the signs and symptoms of cardiovascular problems, regardless of the medical condition treating with clarithromycin.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm597862.htm
In Hong Kong, there are 52 registered pharmaceutical products containing clarithromycin, and are prescription-only medicines. So far, the Department of Health (DH) has received 8 cases of adverse drug reaction related to clarithromycin, of which one case was related to cardiac arrest. In light of the above FDA’s announcement, letters to inform local healthcare professionals will be issued, and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Friday, Feb 23, 2018
Issued at HKT 15:00
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