Notice
[Posted 03/01/2011] ISSUE: FDA updated the public about an ongoing safety review of abacavir and a possible increased risk of heart attack. There has been conflicting information on the potential increased risk of heart attack with abacavir (Ziagen) treatment. An increased risk of heart attack (myocardial infarction or MI) has been seen in several observational studies and one randomized controlled trial (RCT) with abacavir. However, an increased risk of heart attack has not been seen in other RCTs and the safety database maintained by the drug manufacturer.
FDA conducted a meta-analysis of 26 randomized clinical trials that evaluated abacavir. This meta-analysis did not show an increased risk of MI associated with the use of abacavir. FDA will continue to communicate any new safety information to the public as it becomes available.
BACKGROUND: Abacavir is an antiviral medication used in combination with other antiretroviral drugs [abacavir and lamivudine (Epzicom); abacavir, lamivudine, and zidovudine (Trizivir)] for the treatment of HIV-1 infection.
RECOMMENDATION: Healthcare professionals should continue to prescribe abacavir according to the professional label. Patients should not stop taking their abacavir without first talking to their healthcare professional. For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.
Warning
Lamivudine, when used alone or in combination with other antiviral medications, can cause serious damage to the liver and a condition called lactic acidosis. If you experience any of the following symptoms, call your doctor immediately: nausea, loss of appetite, excessive tiredness, weakness, dark yellow or brown urine, unusual bleeding or bruising, flu-like symptoms, yellowing of the skin or eyes, and pain in the upper right part of your stomach. Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to lamivudine.
Epivir tablets and liquid (used to treat human immunodeficiency virus [HIV]) are not interchangeable with Epivir-HBV tablets and liquid (used to treat hepatitis B infection). Epivir contains a higher dose of lamivudine than Epivir-HBV. Treatment with Epivir-HBV in patients infected with HIV may cause the HIV virus to be less treatable with lamivudine and other medicines. If you have both HIV and hepatitis B, you should take only Epivir. If you are taking Epivir-HBV for hepatitis B infection, talk to your doctor about your risks for HIV infection.
Why is this medication prescribed?
Lamivudine (Epivir) is used in combination with other medications to treat human immunodeficiency virus (HIV) infection in patients with acquired immunodeficiency syndrome (AIDS). Lamivudine is not a cure and may not decrease the number of HIV-related illnesses. Lamivudine does not prevent the spread of HIV to other people. Lamivudine (Epivir-HBV) is used to treat hepatitis B infection. Lamivudine is in a class of medications called nucleoside reverse transcriptase inhibitors. It works by stopping the spread of the HIV and hepatitis B viruses.
How should this medicine be used?
Lamivudine comes as a tablet and liquid to take by mouth. Lamivudine (Epivir) is usually taken every 12 hours (twice a day). Lamivudine (Epivir-HBV) is usually taken once a day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take lamivudine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Continue to take lamivudine even if you feel well. Do not stop taking lamivudine without talking to your doctor.
Other uses for this medicine
Lamivudine is also used sometimes in combination with zidovudine (Retrovir, AZT) to treat healthcare workers or other individuals exposed to HIV infection after accidental contact with HIV-contaminated blood, tissues, or other body fluids. Talk to your doctor about the possible 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 lamivudine,
tell your doctor and pharmacist if you are allergic to lamivudine or any other drugs.
tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially trimethoprim/sulfamethoxazole (Bactrim, Septra) and vitamins.
tell your doctor if you have or have ever had hepatitis B, kidney disease, or pancreas disease (in children only).
tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking lamivudine, call your doctor. You should not breast-feed while taking lamivudine.
What should I do if I forget a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next 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 medication cause?
Lamivudine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
diarrhea
headache
fatigue
chills
nausea
vomiting
loss of appetite
dizziness
trouble sleeping
depression
stuffy nose
cough
If you experience any of the following symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:
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 http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].
What storage conditions are needed for this medicine?
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). The liquid does not need to be refrigerated; however, it should be stored in a cool place. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of emergency/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.
