vigabatrin

What is the most important information I should know about vigabatrin?

Some babies treated with vigabatrin have had abnormal brain changes seen on magnetic resonance imaging (MRI). Tell any doctor who treats your baby that the child is taking vigabatrin.

Some people have thoughts about suicide while taking seizure medication. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

What is vigabatrin?

Vigabatrin is an anti-epileptic medicine, also called an anticonvulsant.

Vigabatrin is used in combination with other medications to treat complex partial seizures in adults and children who are at least 10 years old. Vigabatrin powder for oral solution is used to treat infantile spasms in babies and children between the ages of 1 month and 2 years.

Vigabatrin may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking vigabatrin?

Vigabatrin is available only from a certified pharmacy under a special program. You must be registered in the program and agree to have vision exams before, during, and shortly after taking vigabatrin. Be sure you understand the risks and benefits of taking this medicine.

Tell your doctor if you (or the child taking this medicine) have ever had:

• vision problems;
• kidney disease;
• anemia (low red blood cells); or
• depression, a mood disorder, mental illness, or suicidal thoughts or actions.

Some people have thoughts about suicide while taking vigabatrin. Your doctor will need to check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Do not start or stop taking seizure medication during pregnancy without your doctor's advice. Having a seizure during pregnancy could harm both mother and baby. Tell your doctor right away if you become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of vigabatrin on the baby.

Do not give this medicine to a child without medical advice.

How should I take vigabatrin?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may take vigabatrin with or without food.

Vigabatrin powder must be mixed only with water, and can be given to the child with a meal. Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

You will need a thorough eye exam before you start taking vigabatrin and then every 3 months during treatment, even if your vision seems normal. Eye exams may not fully prevent vision damage, but they will help your doctor decide whether to change your treatment plan. Stay alert to any changes in your vision and report them to your doctor right away.

If you stop taking vigabatrin, you should have another eye exam about 3 to 6 months after your last dose.

It may be more difficult to test vision in a baby or young child. However, your doctor may still prescribe vigabatrin for the child if the benefit of preventing seizures outweighs any risk. Tell the doctor right away if you think your child's vision may be changing.

Do not stop using vigabatrin suddenly, even if you feel fine. Stopping suddenly may cause increased seizures. Follow your doctor's instructions about tapering your dose.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Overdose symptoms may include severe drowsiness or dizziness, confusion, trouble speaking, feeling agitated or irritable, unusual thoughts or behavior, increased seizures, slow heart rate, weak or shallow breathing, or fainting.

What should I avoid while taking vigabatrin?

What are the possible side effects of vigabatrin?

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), depressed, or have thoughts about suicide or hurting yourself.

• increased or worsening seizures;
• any change in your vision, no matter how mild;
• unusual or involuntary eye movements;
• severe drowsiness, fussiness, or feeding problems (in a baby taking vigabatrin);
• numbness, tingling, or burning pain in your hands or feet;
• weight gain with or without swelling;
• signs of an ear infection --fever, ear pain or full feeling, trouble hearing, drainage from the ear, fussiness in a child; or
• low red blood cells (anemia) --pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

Some babies treated with vigabatrin have had abnormal brain changes seen on magnetic resonance imaging (MRI). It is not known if these changes are caused by vigabatrin or if they are harmful. Tell any doctor who treats your baby that the child is taking vigabatrin.

Common side effects may include:

• blurred vision or other eye problems;
• drowsiness, dizziness, feeling tired;
• problems with walking or coordination;
• tremors or shaking;
• aggressive behavior;
• confusion, problems with thinking or memory;
• weight gain;
• joint pain;
• cold symptoms such as stuffy nose, sneezing, sore throat; or
• (in babies) fussiness, ear infection, cough, breathing problems.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect vigabatrin?

Other drugs may affect vigabatrin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about vigabatrin.