(RxWiki News) The US Food and Drug Administration (FDA) has issued a safety communication for a common antibiotic.
The FDA is warning health care providers to use caution when prescribing the antibiotic Biaxin (clarithromycin) to patients with heart disease. This recommendation is based on the results of a follow-up study of patients with coronary heart disease who received clarithromycin 10 years prior in a study that first identified this safety issue.
The original study found an unexpected increase in deaths among those with coronary heart disease who took clarithromycin for two weeks. This risk became apparent after a year or longer. There is currently no clear explanation as to why this happened.
Based on the results from the 10-year follow-up, the FDA has added a new warning to clarithromycin regarding this increased risk of death in those with heart disease.
Clarithromycin is an antibiotic used to treat certain types of bacterial infections. It works by stopping the growth of bacteria. However, other antibiotics can treat bacterial infections. The FDA is recommending that patients tell their health care providers if they have heart disease. The agency is recommending that health care providers weigh the risks and benefits of using clarithromycin in patients with heart disease.
However, do not stop taking your heart disease medicine or antibiotic without first talking to your health care provider. Stopping your medication without direction from your health care provider can harm you.
Seek immediate medical attention if you experience symptoms of a heart attack or stroke. These symptoms include chest pain, shortness of breath (trouble breathing), slurred speech, or pain or weakness on one side of the body.
The FDA said it will continue to monitor the safety of clarithromycin.
The FDA published the results of this follow-up study in late February. Various Danish nonprofit funds supported this research. The researchers disclosed no potential conflicts of interest.