What is the most important information I should know about vigabatrin?
Taking vigabatrin can cause permanent vision loss, even after you stop using this medicine. Tell your doctor right away about any changes in your vision. You must have frequent eye exams while taking this medicine.
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.
Vigabatrin should be used only by people who have been unable to control their seizures with several other medications.
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. The powder form of vigabatrin is used to treat infantile spasms in babies and children between the ages of 1 month and 2 years.
Vigabatrin can cause serious side effects and should be used only by people who have been unable to control their seizures with several other medications.
Vigabatrin may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking vigabatrin?
Some people taking vigabatrin have developed vision problems within weeks to years after starting treatment. Vision loss caused by vigabatrin may be permanent, and you may notice only mild symptoms at first. Talk to your doctor about this possibility.
Vigabatrin is available only from a certified pharmacy under a special program called SHARE. You must be registered in the program and agree to have vision exams every 3 months while taking vigabatrin. Be sure you understand the risks and benefits of taking this medicine.
You should not use vigabatrin if you are allergic to it.
To make sure vigabatrin is safe for you, 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, mood disorder, mental illness, or suicidal thoughts or actions.
Some people have thoughts about suicide while taking seizure medication. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.
Follow your doctor's instructions about taking seizure medication if you are pregnant. Seizure control is very important during pregnancy, and having a seizure could harm both mother and baby. Do not start or stop taking this medicine without your doctor's advice, and tell your doctor right away if you become pregnant.
If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of vigabatrin on the baby.
Vigabatrin can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using vigabatrin.
How should I take vigabatrin?
Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended.
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. Carefully follow your doctor's dosing instructions if you are giving vigabatrin to a child or infant.
Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.
Anyone taking vigabatrin can develop vision problems that could get worse, even after you stop using this medicine. The more you take vigabatrin, the more likely you are to develop severe vision problems.
You will need a thorough eye exam when you start taking vigabatrin and then every 3 months during treatment. 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 ever stop taking vigabatrin, you may still need continued eye exams.
Call your doctor if your complex partial seizures do not improve after 3 months of treatment, or if your baby's infantile spasms do not improve after 2 to 4 weeks of treatment.
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.
Store vigabatrin in the original container at room temperature away from moisture and heat.
What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
Call your doctor for instructions if your baby is taking vigabatrin and misses a dose, takes only part of a dose, or spits up or vomits after taking the medicine.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
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?
This medicine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
What are the possible side effects of vigabatrin?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Taking vigabatrin can cause permanent vision loss. Tell your doctor right away about any changes in your vision. If a child is taking vigabatrin: Tell the doctor right away if the child shows signs of vision changes, such as bumping into things or being easily startled or surprised.
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.
Call your doctor at once if you have:
- 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;
- problems with thinking or memory;
- joint pain; or
- cold symptoms such as stuffy nose, sneezing, sore throat.
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 interact with 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.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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