| IMPORTANT WARNING:
| IMPORTANT WARNING
| WHY is this medicine prescribed?
| HOW should this medicine be used?
| Are there OTHER USES for this medicine?
| What SPECIAL DIETARY instructions should I follow?
| What should I do IF I FORGET to take a dose?
| What SIDE EFFECTS can this medicine cause?
| What should I know about STORAGE and DISPOSAL of this medication?
| What should I do in case of OVERDOSE?
| What OTHER INFORMATION should I know?
[Posted 03/24/2015]ISSUE:FDA is warning that serious slowing of the heart rate can occur when the antiarrhythmic drug amiodarone is taken together with either the hepatitis C drug ledipasvir/sofosbuvir (Harvoni) or with sofosbuvir (Sovaldi) taken in combination with another direct acting antiviral for the treatment of hepatitis C infection. FDA is adding information about serious slowing of the heart rate, known as symptomatic bradycardia, to the ledipasvir/sofosbuvir and sofosbuvir labels. FDA is recommending that health care professionals should not prescribe either ledipasvir/sofosbuvir or sofosbuvir combined with another direct acting antiviral, such as the investigational drug daclatasvir or simeprevir (Olysio), with amiodarone.
FDA review of submitted postmarketing adverse event reports found that patients can develop a serious and life-threatening symptomatic bradycardia when either ledipasvir/sofosbuvir or sofosbuvir combined with another direct-acting antiviral is taken together with amiodarone. The reports included the death of one patient due to cardiac arrest and three patients requiring placement of a pacemaker to regulate their heart rhythms. The other patients recovered after discontinuing either the hepatitis C drugs or amiodarone, or both (see Data Summary). The cause of these events could not be determined. FDA will continue to monitor ledipasvir/sofosbuvir and sofosbuvir for risks of serious symptomatic bradycardia and further investigate the reason why the use of amiodarone with these hepatitis C drugs led to the heart-related events.
BACKGROUND:For a Data Summary and additional recommendations for health professionals and patients, see the FDA Drug Safety Communication at: Web Site.
RECOMMENDATION:Health care professionals should not prescribe either ledipasvir/sofosbuvir or sofosbuvir combined with another direct-acting antiviral drug with amiodarone. However, in cases where alternative treatment options are unavailable, FDA recommends heart monitoring in an inpatient hospital setting for the first 48 hours. Subsequently, monitoring in a doctor’s office or self-monitoring of the heart rate should be done every day through at least the first 2 weeks of treatment.
Due to the long half-life of amiodarone, patients discontinuing amiodarone just prior to starting ledipasvir/sofosbuvir, or sofosbuvir in combination with another direct-acting antiviral, should also undergo similar cardiac monitoring as outlined above.
Patients taking either ledipasvir/sofosbuvir or sofosbuvir combined with another direct-acting antiviral drug with amiodarone should seek medical attention right away if they experience signs or symptoms of symptomatic bradycardia such as:
- Near-fainting or fainting
- Dizziness or light-headedness
- Excessive tiredness
- Shortness of breath
- Chest pains
- Confusion or memory problems
For more information visit the FDA website at: Web Siteand Web Site.
Amiodarone may cause lung damage that can be serious or life-threatening. Tell your doctor if you have or have ever had any type of lung disease or if you have ever developed lung damage or breathing problems while taking amiodarone. If you experience any of the following symptoms, call your doctor immediately: fever, shortness of breath, wheezing, other breathing problems, cough, or coughing or spitting up blood.
Amiodarone may also cause liver damage. Tell your doctor if you have or have ever had liver disease. If you experience any of the following symptoms, call your doctor immediately: nausea, vomiting, dark colored urine, excessive tiredness, yellowing of the skin or eyes, itching, or pain in the upper right part of the stomach.
Amiodarone may cause your arrhythmia (irregular heart rhythm) to worsen or may cause you to develop new arrhythmias.Tell your doctor if you have ever been dizzy or lightheaded or have fainted because your heartbeat was too slow and if you have or have ever had low levels of potassium or magnesium in your blood; heart or thyroid disease; or any problems with your heart rhythm other than the arrhythmia that is being treated. Tell your doctor and pharmacist if you are taking any of the following medications: antifungals such as fluconazole (Diflucan), ketoconazole (Nizoral), and itraconazole (Sporanox); azithromycin (Zithromax); beta blockers such as propranolol (Inderal); calcium channel blockers such as diltiazem (Cardizem, Dilacor, Tiazac, others) and verapamil (Calan, Covera, Isoptin, Verelan); cisapride (Propulsid); clarithromycin (Biaxin); diuretics ('water pills'); dofetilide (Tikosyn); erythromycin (E.E.S., E-Mycin, Erythrocin); fluoroquinolone antibiotics such as ciprofloxacin (Cipro), gatifloxacin (Tequin) (not available in the US), levofloxacin (Levaquin), lomefloxacin (Maxaquin) (not available in the US), moxifloxacin (Avelox), norfloxacin (Noroxin), ofloxacin (Floxin), and sparfloxacin (Zagam) (not available in the US); other medications for irregular heartbeat such as digoxin (Lanoxin), disopyramide (Norpace), flecainide (Tambocor), phenytoin (Dilantin), procainamide (Procanbid, Pronestyl), quinidine (Quinidex) and sotalol (Betapace); and thioridazine (Mellaril). If you have any of the following symptoms, call your doctor immediately: lightheadedness; fainting; fast, slow, or pounding heartbeat; or feeling that your heart has skipped a beat.
You will probably be hospitalized for one week or longer when you begin your treatment with amiodarone. Your doctor will monitor you carefully during this time and for as long as you continue to take amiodarone. Your doctor will probably start you on a high dose of amiodarone and gradually decrease your dose as the medication begins to work. Your doctor may decrease your dose during your treatment if you develop side effects. Follow your doctor's directions carefully.
Do not stop taking amiodarone without talking to your doctor. You may be hospitalized when you stop taking amiodarone. Amiodarone may remain in your body for some time after you stop taking it, so your doctor will watch you carefully during this time.
Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests, such as blood tests, X-rays, and electrocardiograms (EKGs, tests that record the electrical activity of the heart) before and during your treatment to be sure that it is safe for you to take amiodarone and to check your body's response to the medication.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with amiodarone and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also obtain the Medication Guide from the FDA website: Web Site.
Talk to your doctor about the risks of taking amiodarone.
WHY is this medicine prescribed?
Amiodarone is used to treat and prevent certain types of serious, life-threatening ventricular arrhythmias (a certain type of abnormal heart rhythm when other medications did not help or could not be tolerated. Amiodarone is in a class of medications called antiarrhythmics. It works by relaxing overactive heart muscles.
HOW should this medicine be used?
Amiodarone comes as a tablet to take by mouth. It is usually taken once or twice a day. Your doctor will tell you to take amiodarone with or without food; be sure to take it the same way each time.Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take amiodarone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Are there OTHER USES for this medicine?
Amiodarone is also sometimes used to treat other types of arrhythmias. Talk to your doctor about the risks of using this drug for your condition.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before taking amiodarone,
- tell your doctor and pharmacist if you are allergic to amiodarone, iodine, or any other medications.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: antidepressants ('mood elevators') such as trazodone; anticoagulants ('blood thinners') such as warfarin (Coumadin); certain cholesterol lowering medications such as atorvastatin (Lipitor), cholestyramine (Questran), lovastatin (Mevacor), and simvastatin (Zocor); cimetidine (Tagamet); clopidogrel (Plavix); cyclosporine (Neoral, Sandimmune); dextromethorphan (a medication in many cough preparations); fentanyl (Actiq, Duragesic); HIV protease inhibitors such as indinavir (Crixivan), and ritonavir (Norvir); loratadine (Alavert, Claritin); medications for diabetes or seizures; methotrexate (Rheumatrex); narcotic medications for pain; and rifampin (Rifadin, Rimactane). Many other medications may interact with amiodarone, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. Your doctor may have to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor what herbal products you are taking, especially St. John's wort.
- tell your doctor if you have or have ever had any of the conditions mentioned in the IMPORTANT WARNING section or problems with your blood pressure.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. Talk to your doctor if you plan to become pregnant or breast-feed during the first several months after your treatment because amiodarone may remain in your body for some time after you stop taking it.If you become pregnant while taking amiodarone, call your doctor.
- talk to your doctor about the risks of taking this medication if you are 65 years of age or older. Older adults should not usually take amiodarone because it is not as safe or effective as other medication(s) that can be used to treat the same condition.
- if you are having surgery, including dental surgery or laser eye surgery, tell your doctor or dentist that you are taking amiodarone.
- plan to avoid unnecessary or prolonged exposure to sunlight or sunlamps and to wear protective clothing, sunglasses, and sunscreen. Amiodarone may make your skin sensitive to sunlight. Exposed skin may turn blue-gray and may not return to normal even after you stop taking this medication.
- you should know that amiodarone may cause vision problems including permanent blindness. Be sure to have regular eye exams during your treatment and call your doctor if your eyes become sensitive to light or if you see halos, or have blurred vision or any other problems with your vision.
- you should know that amiodarone may remain in your body for several months after you stop taking it. You may continue to experience side effects of amiodarone during this time. Be sure to tell every health care provider who treats you or prescribes any medication for you during this time that you have recently stopped taking amiodarone.
What SPECIAL DIETARY instructions should I follow?
Do not drink grapefruit juice while you are taking this medication.
What should I do IF I FORGET to take a dose?
Skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What SIDE EFFECTS can this medicine cause?
Amiodarone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- loss of appetite
- decreased sex drive
- difficulty falling asleep or staying asleep
- dry eyes
- changes in ability to taste and smell
- changes in amount of saliva
Some side effects can be serious. If you experience any of the following symptoms, or those listed in the IMPORTANT WARNING section, call your doctor immediately:
- weight loss or gain
- intolerance to heat or cold
- thinning hair
- excessive sweating
- changes in menstrual cycle
- swelling in the front of the neck (goiter)
- eye pain
- swelling of the hands, feet, ankles, or lower legs
- uncontrollable shaking of a part of the body
- movements that you cannot control
- poor coordination or trouble walking
- numbness or tingling in the hands, legs, and feet
- muscle weakness
Amiodarone may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at
] or by phone [1-800-332-1088].
What should I know about STORAGE and DISPOSAL of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Protect this medication from light. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
What should I do in case of OVERDOSE?
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include:
- slow heartbeat
- blurred vision
What OTHER INFORMATION should I know?
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
Selected Revisions: April 15, 2015.