Warnings & Recalls for Arava
Arava and Liver Damage Boxed Warning
In July 2010, the
U.S. Food and Drug Administration released a
boxed warning concerning the risk of developing
liver damage while taking Arava. To prevent serious risks, patients who have
liver damage or
elevated liver enzymes should not take Arava. Patients who are using other medicines during treatment should use
extreme caution.During use of Arava, patients should have their
liver function and
blood tested regularly.
Men and Arava
Men who are taking Arava and are
sexually active should be aware that if a woman becomes pregnant by a man using this medication, the
fetus may be harmed. The effect on the fetus if fathered by a man who has taken Arava is
not yet known.If you are
sexually active or are
planning to father a child,
ask your doctor about
safely doing so. Your doctor may recommend that you end treatment with Arava and use other medicines to remove this drug from your body. Consult your doctor about
safely having sex while taking Arava.
Arava and Pregnancy
Arava is
contraindicated in women who are
pregnant, of
childbearing age, or may become pregnant and
are not using an effective form of
contraception.Arava is an
FDA pregnancy Category X medicine. Arava
should not in any case be used by a woman who is
pregnant. In order for a female patient to be prescribed Arava, tests must be done to ensure that she is not pregnant. Patients must also use an
effective form of birth control for as long as Arava is in the patient's system. Taking Arava during pregnancy
could cause birth defects or
death of the fetus. It is
not known if Arava passes through breastmilk and may harm a
nursing baby. Patients
should not breast-feed while using Arava.If you become
pregnant, are
late for your period or
think you may be pregnant while taking Arava, call your doctor
immediately.Women who are
planning to become pregnant should
consult their doctor to end treatment of Arava and have this medicine eliminated from their body so they may safely have a child.
General Information
Let your doctor know about any conditions you have that may put you at risk when taking Arava. Arava is
not safe for and
should not be used by patients who:
- are pregnant, breasfeeding, or are planning to become pregnant
- are allergic to any ingredient contained in Arava
- who are not using an effective form of birth control and may become pregnant
- have bone marrow problems
- have a weak immune system or an immune system disorder
- are fighting a serious and uncontrolled infection
- have liver disease or failure, or have a weakened liver function
- have ever had hepatitis B or C
Ask your doctor if you may safely use Arava as a treatment for your arthritis and tell your doctor if you have any of the previously listed conditions or if you:
- are using any other medicines, supplements, vitamins or herbal products
- have any allergies
- have ever had any lung problems, tuberculosis, high blood pressure (hypertension), problems with your blood, bone marrow deficiency, diabetes, or liver disease or damage
- drink alcoholic beverages frequently or in large amounts
- have a history of kidney disease (or if you are on dialysis)
Arava may weaken the
immune system. If you are taking Arava,
avoid people who have infections or are sick.
Do not receive any
"live" vaccines without consent from your doctor.Arava can cause
serious liver, lung and skin problems or diseases which may even be fatal. See "
Side Effects" tab for information on signs of these dangers. If you develop any serious side effects,
call your doctor right away for help.
Elderly patients may be
more sensitive to the side effects of Arava and should be careful during treatment.
Avoid physical activities that may put you at risk of injury and bruising. Arava may lower the amount of platelets in your blood and
reduce the ability to form blood clots. If injured while using Arava you may have abnormal bleeding or bruising and should tell your doctor
at once.
Arava Interactions
Be sure to
let your healthcare provider know about all medicines you are using. Some drugs may be
unsafe to use while taking Arava. The following
may interact with Arava:
- Methotrexate
- Rifampin
- blood thinner such as Warfarin
- drugs that weaken the immune system
- medications that have side effects of nerve problems
- cholestyramine
- liver-damaging medicines (such as HIV or psoriasis treatments)
Do not drink alcohol while using Arava. This can lead to an
increase in liver damage or unsafe side effects including severe dizziness or drowsiness that my make you unable to perform certain activities.
Arava Treatment and Use
Arava | Leflunomide is a disease-modifying antirheumatic drug (DMARD) marketed by Aventis for treating rheumatoid arthritis. Arava may be used alone or combined with other medicines for the following:
- reducing joint pain or aching
- improving or increasing physical function
- preventing the risk of structural damage to joints
Arava does not cure rheumatoid arthritis.
Arava has not been approved for use in children.
How Does Arava Work?
Arava works in the joints by reducing the amount of joint-destroying lymphocytes. In doing so, Arava decreases symptoms and progression of rheumatoid arthritis, preventing further damage.
How to Take Arava
Arava comes in tablet form to be taken by mouth with a full glass of water. Arava is typically prescribed to be taken as 100mg tablets once each day. Your doctor may increase your dosage after three days of treatment. Do not take more or less than the amount prescribed by your doctor.
Do not stop taking Arava even if symptoms have been reduced. Continue using Arava until otherwise instructed by your doctor. After treatment, your doctor may prescribe another medicine to be used to remove Arava from the body. Arava may stay in your system for as long as two full years.
urning, numbness or pain in chest, rapid or irregular heart rate and trouble breathing