On April 8, 2013, a new study published early online in Cancer, a peer-reviewed journal of the American Cancer Society, found a potential link between amiodarone (Cordarone) and cancer. Amiodarone is an antiarrhythmic agent used to treat various types of ventricular arrhythmias (abnormal heart rhythms).
Vincent Yi-Fong Su, MD, of the Taipei Veterans General Hospital in Taiwan, and his colleagues analyzed 6,418 patients taking the drug and followed them for an average of 2.57 years. 280 individuals developed cancer (a standardized incidence ratio of 1.18). The researchers found that patients who were male or who received high cumulative daily doses of amiodarone within the first year had an increased risk of developing cancer.
Approved in 1985, amiodarone is intended for use only in patients with life-threatening arrhythmias because its use is accompanied by substantial toxicity. It is available for oral and intravenous administration. Amiodarone carries a black box warning related to pulmonary toxicity, hepatotoxicity, and fatal arrhythmia.
Using data from FAERS, from 11/01/1997 to 08/27/2012, aggregated and standardized by the AdverseEvent RxFilter process, we analyzed the reported adverse events involving cancer for patients taking amiodarone (Cordarone).
We identified 209 cases where amiodarone was determined to be the primary suspect associated with cancer. We identified 114 hospitalizations and 33 patient deaths involving cancer where amiodarone was determined to be the primary suspect.
Note: This analysis does not take into account the number of patients on each medication. In order to calculate the total number of cases involving cancer, we aggregated case reports listing the following adverse events: MedDRA System Organ Class: Neoplasms benign, malignant and unspecified (incl cysts and polyps).