[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.
Lamivudine and zidovudine may stop your body from making enough blood cells. Tell your doctor if you have or have ever had any blood disorders such as anemia or bone marrow problems. If you experience any of the following symptoms, call your doctor immediately: unusual bleeding or bruising; shortness of breath; pale skin; fever, sore throat, chills, and other signs of infection; or unusual tiredness or weakness.
Lamivudine and zidovudine may cause muscle disorders. Tell your doctor if you have or have ever had any disease or swelling of the muscles. If you experience muscle pain or weakness, call your doctor immediately.
When used alone or in combination with other antiretroviral medication, lamivudine and zidovudine may also cause serious damage to the liver and a condition called lactic acidosis. Tell your doctor if you drink or have ever drunk large amounts of alcohol and if you have or have ever had liver disease. Tell your doctor and pharmacist if you are taking acetaminophen (Tylenol) and if you have been taking medication to treat HIV infection for a long time. If you experience any of the following symptoms, call your doctor immediately: fatty and foul-smelling stools, upset stomach, extreme tiredness, unusual bleeding or bruising, lack of energy, loss of appetite, pain in the upper right part of the stomach, yellowing of the skin or eyes, or flu-like symptoms.
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to lamivudine and zidovudine.
The combination of lamivudine and zidovudine is used to treat human immunodeficiency virus (HIV) in patients with or without acquired immunodeficiency syndrome (AIDS). Lamivudine and zidovudine are in a class of antiviral medications called synthetic nucleoside analogues. They work by slowing the spread of HIV infection in the body. Lamivudine and zidovudine is not a cure and may not decrease the number of HIV-related illnesses. Lamivudine and zidovudine does not prevent the spread of HIV to other people.
The combination of lamivudine and zidovudine comes as a tablet to take by mouth. It is usually taken twice a day with or without food. To help you remember to take this medication, take it around the same time every day. Follow the directions on your prescription label carefully and ask your doctor or pharmacist to explain any part you do not understand. Take this medication exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Lamivudine and zidovudine controls HIV infection but does not cure it. Continue to take lamivudine and zidovudine even if you feel well. Do not stop taking lamivudine and zidovudine without talking to your doctor.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Unless your doctor tells you otherwise, continue your normal diet.
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.
headache
upset stomach
diarrhea
constipation
loss of appetite
dizziness
difficulty falling asleep or staying asleep
excessive tiredness
depression
stuffy nose
cough
hair loss
hives
skin rash
itching
difficulty breathing or swallowing
seizures
numbness, tingling, or burning in your fingers or toes
fever
wheezing
Lamivudine and zidovudine may cause other side effects. Call your doctor if you have any unusual problems while taking lamivudine and zidovudine.
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].
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). 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 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.
Keep all appointments with your doctor and the laboratory.
Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking lamivudine and zidovudine.
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.
Last Revised - 03/16/2011
AHFS® Consumer Medication Information. © Copyright, 2012. 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.