Amiodarone (pacerone & nexterone) is a medication formulated to improve heartbeat rhythm. Doctors prescribe the drug to patients with life-threatening ventricle-related heart rhythm disorders to ensure the heart beats normally. The ventricles are the heart’s lower chambers that allow blood flow out from the heart.
The medication Amiodarone (pacerone) is affected for treating ventricular fibrillation and ventricular tachycardia. The medication was first discovered in 1961 and received final FDA approval in December 1985. The drug has not been approved by the Food and Drug Administration (FDA) for any other condition.
How Amiodrone Works
When the broad-spectrum antiarrhythmic drug is either taken orally or through an injection, Amiodarone (pacerone) can correct abnormal heart rate rhythms. However, the medication can lead to serious side effects that could be severe or fatal. The drug is known to produce complex effects on the heart’s electrical activity that is responsible for maintaining rhythm. The drug works by:
- Delaying heart rate by recharging the electrical system once the heart has contracted after a beat;
- Prolong the heart’s electrical phase when the muscle cells of the heart are stimulated through in electrical response;
- Slow the speed of the heart’s electrical conduction;
- Reduce the rapidity of the heart’s electrical impulse firing as a natural heart pacemaker;
- Slow electrical conduction through numerous illogical pathways responsible for causing an arrhythmia.
The medication might also affect the heart because it dilates (enlarges) blood vessels that can help drop blood pressure that might be especially important for patients suffering congenital heart failure.
Serious Side Effects
The FDA has initiated Black Box (most serious) Warnings to alert patients and their doctors about the dangerous side effects associated with Amiodarone (pacerone & nexterone). The FDA states that the medication should be used only if the patient has a life-threatening irregular heartbeat or arrhythmia. This is because the drug poses serious side effects that could involve severe liver problems, lung issues, loss of vision, and a worsening of the patient’s already irregular heartbeat.
The FDA warns that all patient should take the first dose of brand-name Amiodarone or generic form pacerone after being admitted to the hospital to ensure the safety of their well-being and the drug’s efficacy. The nursing staff and doctor will likely need to monitor the patient while in the hospital to ensure they receive the correct dosage. Known specific side effects include:
- Elevated Risk of Developing Vision Problems – Amiodarone (pacerone & nexterone) can cause the patient’s eyes to become dry, requiring OTC artificial tears or lubricating eye solutions. Patients who develop blurry vision problems often see halos that appear around objects or develop a high sensitivity to light.
- Sun Sensitivity – This medication can increase a patient’s sensitivity to the sun or turn their skin to a gray/bluish color. It is recommended that patients taking Amiodarone (pacerone & nexterone) avoid sun rays and wear protective clothing/sunscreen when out in the sun for minutes or hours. Doctors recommend that patients should avoid using tanning beds or sun lamps to prevent severe sunburns.
- Elevated Risk of Developing Lung Problems – Some patients taking Amiodarone (pacerone & nexterone) have developed fatal lung injuries and lung disease. Common Amiodrone-related lung problem symptoms involve shortness of breath, difficulty in breathing, wheezing, spitting up blood, and/or chest pain.
- Allergic Reactions including height, itching, skin rash, and swelling of the tongue, based and/or lips.
- Liver Problems – Some individuals develop unusual symptoms involving the liver including dark urine, unusual weakness, and tiredness or a yellowing of the skin (jaundice) of the whites of the eyes.
- Gut Issues – Nausea, vomiting, spitting up blood and severe stomach pains can be common stomach problem symptoms associated with taking the brand-name a generic version of the heart rhythm medication.
- Thyroid Problems – Thinning hair, weight gain, weight loss, weakness, decreased tolerance for cold or heat or increased skin sensitivity could all be signs of thyroid problems associated with taking this medication.
- Nerve Damage – Difficulty in walking, uncontrolled movements, muscle weakness or neuropathy (numbness, tingling, or pain) in the feet and/or hands might be a sign of Amiodarone-related side effects.
More common but less serious symptoms and side effects associated with taking Amiodarone (pacerone & nexterone) include:
- Nausea and vomiting
- Lack of coordination
- Stomach pain
- Unusual or uncontrollable body movements
- Diminished sexual drive and/or performance
Major Drug Interactions
Amiodarone (pacerone) as an oral tablet form has serious interactions with some other drugs, vitamins, supplements, and herbs when taken. Because of that, patients should discuss the management of their medications with their doctors. Even a mild drug interaction can cause serious problems in patients with an already irregular heart rate. The most common medication interactions involving Amiodarone (pacerone & nexterone) include:
- Antibiotic Medications – Taking Amiodarone (pacerone) concomitantly with some antibiotics could exacerbate an irregular heartbeat. These antibiotics include levofloxacin, fluconazole, clarithromycin, and erythromycin.
- Antiviral Medications – Taking Amiodarone (pacerone & nexterone) together with antiviral medications could exacerbate already serious side effects like an irregular heartbeat that could lead to a fatal outcome. Because of that, the doctor must closely monitor their patient when taking antiviral drugs with Amiodarone or generic version. These drugs include:
- Aptivus (tipranavir)
- Crixivan (indinavir)
- Invirase (saquinavir)
- Kaletra (lopinavir and ritonavir)
- Lexiva (fosamprenavir)
- Norvir (ritonavir)
- Prezista (darunavir)
- Reyataz (atazanavir)
- Viracept (nelfinavir)
- Blood Thinners – Taking warfarin or other blood thinners concomitantly with Amiodarone (pacerone) could increase the potential risk of the patient experiencing serious bleeding that could lead to death. Because of that, the doctor must monitor the patient’s condition and adjust their dose of blood thinners to minimize any potential risk of harm or death.
- OTC Cough Medicines – Using Amiodarone (pacerone) with dextromethorphan could lead to toxic levels of accumulated dextromethorphan.
- Depression Medication – Some antidepressant medications including trazodone could cause an accumulation of Amiodarone amounts causing serious and sometimes fatal side effects including an irregular heartbeat.
- Organ Transplant Medications – Some patients take medications to prevent the rejection of an organ transplant, including cyclosporine when used concomitantly with Amiodarone could result in accumulated amounts of cyclosporine and cause serious side effects.
- GERD Medications – Taking certain GERD medications including cimetidine together with Amiodarone has the potential of increasing the heart rhythm medication levels in the body which could lead to serious or fatal side effects including an irregular heartbeat.
- Heart Failure Drugs – Taking Amiodarone concomitantly with ivabradine can slow the body’s heart rate down and lead to serious a heart rhythm disorder.
- Heart Treatment Drugs – When prescribing Amiodarone or the generic versions, the treating doctor needs to be aware if their patient is taking other heart treatment drug including flecainide, procainamide, quinidine or other antiarrhythmic medications or digoxin that could reduce the dosage effects of Amiodarone.
- Hepatitis Medications – Some hepatitis drugs when used concomitantly with the heart rhythm medication have the potential of causing severe or life-threatening bradycardia by slowing patient’s heart rate. These drugs include sofosbuvir/simeprevir and Ledipasvir/sofosbuvir.
- Supplements and Herbs – Taking Amiodarone together with St. John’s Wort is known to lower the heartbeat regulating drug levels in the body, reducing the efficiency of the heart rhythm controlling medication.
- High Blood Pressure Drugs – Doctors should be cautious when prescribing Amiodarone with high blood pressure drugs because it could produce serious side effects. These drugs include all beta-blockers and calcium channel blockers.
- High Cholesterol Medication – Taking atorvastatin or simvastatin with Amiodarone could increase cholesterol medication levels in the bloodstream leading to serious and life-threatening side effects. The statin cholestyramine, when taken with the heart rhythm medication, can lower Amiodrone levels in the body, and reduce its efficacy.
- Local Anesthesia Medications – including lidocaine taken concomitantly with Amiodarone can produce debilitating seizures can slow the patient’s heart rate.
- Fentanyl Pain Drugs – taken together with Amiodarone can lower blood pressure, decreased heart rate, and diminish blood flow levels in the heart.
- Seizure Medications – including phenytoin, when taken concomitantly with Amiodarone, has the potential of diminishing Amiodrone levels in the body and diminish its efficacy.
Amiodarone Recall Information
In May 2011, the FDA initiated a Drug Safety Communication concerning connection problems with “certain needle’s pre-filled glass syringes containing adenosine and Amiodarone.” The safety communication alerted the healthcare community after receiving reports “that the adenosine and Amiodarone pre-filled glass syringes can become clogged and malfunction during the process of connecting them to the pin-activated needless IV Access system.”
The Safety Communication Report noted that the “incompatibility is not detected until after the syringe is inserted into the pin-activated needless IV access system. The action of inserting the syringe can cause the pin in the access system to clog or break off in the syringe tip, preventing delivery of the medication.”
The FDA Safety Warning also noted that in some cases “the syringe may damage the IV tubing and/or the needless access system and require reestablishment of the IV access. These [issues] can cause a delay in [the] administration of the medication in emergency situations, and could potentially result in serious harm to patients.”
The brand-name Amiodarone and its generic forms pacerone and nexterone can produce severe side effects that require emergency medical attention. Individuals who have allergic reactions should seek out immediate medical assistance if they develop hives, swelling of the face, tongue, lips, or throat, or have difficulty in breathing. The FDA says that patients should avoid using the drug if allergic to iodine or have specific heart conditions including an AV block or a personal medical history of slower heart beats.
Hiring an Attorney to Prosecute Injuries Related to Amiodarone
If you have suffered serious injuries after taking Amiodarone or the generic versions pacerone and nexterone, you are likely entitled to receive financial compensation for your damages. Our Amiodarone attorneys at the Drug Law Center working on your behalf can file a compensation claim or lawsuit against the medication manufacturer. We work on “no upfront payment” contingency arrangement, meaning if we are unable to secure a financial settlement through negotiation or win your case at trial, you owe us nothing.