Amiodarone: When Off-Label Drug Use Hurts Patients

Washington, DCWhen it comes to medications such as amiodarone, what the patient does not know can definitely hurt him. Problems with amiodarone, such as amiodarone side effects and amiodarone interactions with other drugs, have reportedly put patient's lives at risk. The worst part might be that many of them were prescribed the medication for off-label use.

Off-label drug use is in itself not illegal. Doctors are free to prescribe medications for uses other than those approved by the US Food and Drug Administration. The problem is that amiodarone has reportedly been used for conditions that are not as serious as those approved by the FDA, putting patients at serious risk of harm to treat a condition that may not have been all that serious to begin with. Furthermore, the FDA recommends amiodarone only be used as a last resort for patients with a life-threatening heart condition known as ventricular tachycardia.

Often drugs are considered "last-resort" medications because their side effects are so serious, or the risks are so high, that only in extreme cases should patients be exposed to those risks. Last-resort drugs are meant to be used only when other treatments have not worked.

According to a 2005 warning issued by the FDA, amiodarone is linked to pulmonary toxicity, hepatic injury and worsened arrhythmia, and should be prescribed only for life-threatening ventricular arrhythmias when other treatments are ineffective or are not tolerated.

In the case of amiodarone, up to 17 percent of patients who took the medication in some studies suffered lung damage. Of those who suffered lung damage, approximately 10 percent died. The concern is that many have been prescribed amiodarone for a condition known as atrial fibrillation—a condition that is not necessarily life-threatening, meaning the risks associated with the drug could have been worse than the risks associated with the condition the drug was used to treat.

And, while off-label use of a drug is not illegal, marketing a drug for off-label uses is illegal. According to a 2003 article published by McClatchy (11/04/03), amiodarone makers received FDA letters in 1989, 1992 and 1998, warning them to stop downplaying amiodarone's risks while marketing it as a first-line treatment.

The McClatchy article notes that in 2002, approximately 2.3 million off-label prescriptions for amiodarone were written, making up 82 percent of all amiodarone prescriptions.

In addition to a risk of lung problems, concurrent use of amiodarone (known by the brand names Pacerone and Cordarone) and simvastatin (known by the brand name Zocor) has been linked to an increased risk of rhabdomyolysis, which can cause kidney failure and death. According to the FDA (08/08/08), doctors should avoid doses of simvastatin greater than 20 mg per day in patients who are also taking amiodarone.