FDA Sees Biaxin Heart Risk

FDA says its review of the results of a 10-year follow-up study of patients with coronary heart disease further supports the risk of prescribing AbbVie’s antibiotic Biaxin (clarithromycin) and generics because of a potential increased risk of heart problems or death that can occur years later. An agency safety announcement says a new Warning about the increased risk of death in patients with heart disease has been added to the drug’s labeling and prescribers are being advised to consider using other antibiotics with such patients.

The announcement says that the CLARICOR trial observed an unexpected increase in death among patients with coronary heart disease who received a two-week course if 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,” it says.