Study Links Amiodarone to Increased Risk of Cancer

April 8, 2013 By

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.

Analysis:

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).

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FDA Revises Dose Limitation for Simvastatin Taken With Amiodarone

December 15, 2011 By

Reversing an earlier decision,?the FDA announced on December 15, 2011 that the dose limitation for simvastatin when it is co-administered with the cardiac drug amiodarone has been increased from 10 mg to 20 mg.

On June 8, 2011, the FDA warned about the potential for increased risk of myopathy (muscle disease) from simvastatin and restricted the use of the highest approved dose of simvastatin (80 mg) to 40 mg. The FDA also lowered the maximum safe doses of simvastatin when it is taken with certain interacting drugs. The dose limitation of simvastatin taken with amiodarone was lowered from 20 mg to 10 mg.

However, the FDA overturned this decision and restored the limit?to 20 mg, declaring that, “Unlike other interacting drugs, there were no pharmacokinetic or clinical trial data to support the simvastatin dose reduction approved with amiodarone.?

Analysis:

Simvastatin, developed and marketed by Merck as Zocor, is a cholesterol-lowering drug that works by inhibiting the enzyme HMG-CoA reductase that controls the rate of cholesterol production in the body. Amiodarone, marketed by Wyeth/Pfizer as Cordarone, is an antiarrhythmic drug that treats abnormal rhythms of the heart.

Using data from AERS aggregated and standardized by the AdverseEvent RxFilter process, we analyzed the reported adverse events for patients taking Zocor (simvastatin) co-administered with Cordarone (amiodarone) from 01/01/2004 to 06/30/2011. We identified 453 total patients who reported adverse events. There were 42 reported patient deaths, 274 patient hospitilizations, and 47?cases of disability. The top reported adverse events were rhabdomyolysis (rapid breakdown of muscle), reported by 102 patients, acute renal (kidney) failure reported by 37 patients, and asthenia (muscle weakness), reported by 33 patients.

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