Vigabatrin can cause permanent vision damage, including loss of peripheral vision and having blurry vision. Although vision loss is possible with any amount of vigabatrin, your risk may be greater with the more vigabatrin that you take daily and the longer you take it. Vision loss can happen at any time during treatment with vigabatrin. Tell your doctor if you have or have ever had any vision problems. If you experience any of the following symptoms, call your doctor immediately: think you are not seeing as well as before taking vigabatrin; start to trip, bump into things, or are more clumsy than usual; are surprised by people or things coming in front of you that seem to come out of nowhere; blurry vision; double vision; eye movements you can't control; eye pain; and headache. Vision loss is not likely to be noticed in infants before it is severe. Be sure to call your doctor immediately if you think your baby is not seeing as well as before taking vigabatrin or is acting differently than normal.
Vigabatrin is only available through a special program called SHARE. You and your doctor will need to be enrolled in this program before you can receive vigabatrin. You will need to get vigabatrin from a specialty pharmacy that is enrolled in the program. Your doctor will give you more information about the program, will have you sign an enrollment form, and will answer any questions you have about the program and your treatment with vigabatrin.
As part of the SHARE program, an eye doctor will test your vision within 4 weeks of starting vigabatrin, at least every 3 months during treatment, and 3-6 months after stopping treatment. Vision testing is difficult in infants and may not find vision loss before it is severe. Vision tests cannot prevent vision damage but they are important to decrease further damage from occurring by stopping vigabatrin if vision changes are found. Once detected, vision loss is not reversible. It is possible that further damage can occur after stopping vigabatrin.
Also as part of the SHARE program, your doctor will assess your response to and continued need for vigabatrin. This is done within 2-4 weeks of starting treatment in infants and children, within 3 months of starting treatment in adults, and then on a regular basis as needed for all patients. If your doctor determines that vigabatrin is not working for you, then your treatment should be stopped.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with vigabatrin and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (
http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.
Talk to your doctor about the risks of taking vigabatrin.
National Library of Medicine | National Institutes of Health | Department of Health and Human Services
