The heart drug Pacerone has been associated with an increased risk of liver damage, lung disease (pulmonary toxicity), blindness, and death.
What is Pacerone?
Pacerone (amiodarone) is an anti-arrhythmic drug created by Upsher-Smith Laboratories. It treats ventricular arrhythmias, a type of severe irregular heart rhythm in the two lower chambers of the heart.
What is the problem?
Pacerone is associated with many severe side effects. The FDA has issued warnings about lung damage (pulmonary toxicity), liver damage, and worsening heart rhythm problems. All of these side effects can be deadly. Due to this risk, the FDA says Pacerone should only be used as a drug of last resort.
Signs Heart Problems are Worsening
- Irregular heartbeat
- Heart palpitations
Pulmonary Toxicity Warning Signs
- Shortness of breath
- Irritating cough
- Coughing up blood
Signs of Other Health Problems
- Vision problems
- Loss of muscle coordination in arms and legs
FDA Warning: Pacerone and Lung Disease
The FDA has published a Drug Safety Communication for healthcare professionals to warn about the risk of lung toxicity. This disease can occur in as much as 17% of people taking 400-mg of Pacerone per day. A much higher percentage of patients have other lung injuries. The FDA also warns that pulmonary toxicity is fatal in about 10% of cases.
Toxic Epidermal Necrolysis (TEN)
Toxic Epidermal Necrolysis (TEN) is a rare but life-threatening hyper-sensitive skin reaction. It causes layers of the epidermis (the thin outer layer of the skin) to detach from the lower layers of the skin. Large sections of the skin peel away.
The disease can affect the mucous membranes(in the mouth, throat, eyes, vagina, etc.) which can cause severe damage or infection to these parts of the body. Patients with TEN often require intensive hospital treatment.
FDA Warning: Pacerone + Simvastatin
The FDA published a Safety Communication on December 15, 2011 to warn that combining Pacerone with simvastatin (Zocor) in doses greater than 20-mg per day is associated with an increased risk of muscle injury and myopathy. Simvastatin is a widely-used medication for lowering cholesterol.This Safety Communication was a revision to a communication from June 2011, when they recommended limiting the dose of simvastatin to 10-mg per day.
Muscle Damage and Rhabdomyolysis
Combining Pacerone with high doses of simvastatin is associated with an increased risk of a degenerative muscle disease called myopathy. Over time, untreated myopathy can cause a muscle protein called myoglobin to clog the filtering system in the kidneys. This is called rhabdomyolysis, and it can cause kidney failure and death.
Severe Side Effects of Pacerone
- Lung damage
- Pulmonary fibrosis
- Muscle disease
- Liver damage
- Worsening heart problems
- Skin reactions