Safety Alert
[Posted 03/27/2008] The FDA issued an Early Communication about recent findings of The Data Collection on Adverse Events of Anti-HIV Drugs Study. Data analyses from this study indicate a higher risk of heart attack in patients infected with HIV-1 who were taking abacavir (Ziagen) or didanosine (Videx) as part of their drug therapy. The study is a large observational study of 33,347 HIV-1 infected patients living in North America, Europe and Australia. Patients in this study are being followed to evaluate the short and long term adverse effects of treatment with anti-HIV drugs. FDA continues to evaluate the overall risks and benefits of abacavir and didanosine. This evaluation may result in the need to revise labeling for the products. Until the FDA’s review is complete, health care professionals should evaluate the potential risks and benefits of each HIV-1 antiretroviral drug their patients are taking.
This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. As soon as this review is complete, FDA will communicate the conclusions and recommendations to the public. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#abacavir and http://www.fda.gov/cder/drug/early_comm/abacavir.htm.
Safety Alert
Abacavir may cause severe allergic reactions that can lead to death. Stop taking abacavir and call your doctor immediately if you develop a rash or at least one symptom from two of the following groups:
- fever
- excessive tiredness
- upset stomach, vomiting, diarrhea, or stomach pain
- sore throat, shortness of breath, or cough
The Warning Card your pharmacist gives you will have a written list of these symptoms. Carry the card with you.
If you stop taking abacavir because you had an allergic reaction, never take abacavir again. If you stop taking abacavir for any other reason, do not start taking it again without talking to your doctor.
Abacavir may cause serious liver damage and a blood condition called lactic acidosis. Tell your doctor if you drink large amounts of alcohol and if you have or have ever had liver disease. If you experience any of the following symptoms, call your doctor immediately: unusual bleeding or bruising; loss of appetite; pain in the upper right part of the stomach; yellowing of the skin or eyes; or upset stomach and tiredness that do not get better.
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to abacavir.
Contents of this page:
Why is this medication prescribed?
Abacavir is used in combination with other medications to treat human immunodeficiency virus (HIV) infection in patients with or without acquired immunodeficiency syndrome (AIDS). Abacavir is in a class of antiviral medications called nucleoside reverse transcriptase inhibitors (NRTIs). It works by slowing the spread of HIV infection in the body. Abacavir is not a cure and may not decrease the number of HIV-related illnesses. Abacavir does not prevent the spread of HIV to other people.
How should this medicine be used?
Abacavir comes as a tablet and a solution (liquid) to take by mouth. It is usually taken twice a day with or without food. To help you remember to take abacavir, 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 abacavir exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Continue to take abacavir even if you feel well. Do not stop taking abacavir without talking to your doctor.
Before taking abacavir, carefully read the manufacturer's medication guide that comes with it.
Other uses for this medicine
Abacavir is also used sometimes in combination with other antiviral medications to prevent HIV infection in people who have been exposed to it. Talk to your doctor about the possible risks of using this medication 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 abacavir,
- tell your doctor and pharmacist if you are allergic to abacavir or any other medications.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention the following: methadone. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- in addition to the condition listed in the IMPORTANT WARNING section, tell your doctor if you have or have ever had kidney disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking abacavir, call your doctor. You should not breast-feed while taking abacavir.
- talk to your doctor about the safe use of alcohol while taking this medication.
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?
Abacavir may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- upset stomach
- vomiting
- diarrhea
- loss of appetite
- tiredness
- difficulty falling asleep or staying asleep
Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them or those listed in the IMPORTANT WARNING section, call your doctor immediately:
- muscle or joint pain
- headache
- pain, burning, or tingling in the hands or feet
- swelling of the hands, feet, ankles, or lower legs
- pink eye
- bruises in the mouth
Abacavir 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 http://www.fda.gov/MedWatch/index.html] 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). Store liquid medication at room temperature or in the refrigerator. Do not freeze. 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.
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.
Brand names
- Ziagen®
Brand names of combination products
- Epzicon® containing Abacavir and Lamivudine
- Trizivir® containing Abacavir, Lamivudine, and Zidovudine