Sabril - Side Effects, Uses, Dosage, Overdose, Pregnancy, Alcohol. Sabril can cause serious side effects, including: Permanent vision damage. Magnetic resonance imaging (MRI) changes. Risk of suicidal thoughts or actions. Permanent vision damage: Sabril can damage the vision of anyone who takes it. The most noticeable loss is in your ability to see to the side when you look straight ahead (peripheral vision). If this happens, it will not get better. People who take Sabril do not lose all of their vision, but some people can have severe loss particularly to their peripheral vision. With severe vision loss you may only be able to see things straight in front of you (sometimes called 'tunnel vision'). You may also have blurry vision. Vision loss and use of Sabril in adults: Because of the risk of vision loss, Sabril is used to treat complex partial seizures (CPS) only in people who do not respond well enough to several other medicines. Tell your doctor right away if you: think you are not seeing as well as before you started taking Sabril start to trip, bump into things, or are more clumsy than usualare surprised by people or things coming in front of you that seem to come out of nowhere. These changes can mean that you have damage to your vision. Your doctor will test your visual fields (including peripheral vision) and visual acuity (ability to read an eye chart) before you start Sabril or within 4 weeks after starting Sabril, and at least every 3 months after that until Sabril is stopped. You may not be able to be tested in certain situations. Your doctor will determine if you can be tested. Even if your vision seems fine, it is important that you get these regular vision tests because damage can happen to your vision before you notice any changes. These vision tests cannot prevent the vision damage that can happen with Sabril, but they do allow you to stop Sabril if vision has gotten worse, which usually will lessen further damage. If you do not have these vision tests regularly, your doctor may stop prescribing Sabril for you. You should also have a vision test after Sabril is stopped. Some people are not able to complete testing of vision for medical reasons. If you cannot complete vision testing, your doctor may continue prescribing Sabril, but your doctor will not be able to watch for any vision loss you may get. If you drive and your vision is damaged by Sabril, driving might be more dangerous, or you may not be able to drive safely at all. You should discuss this with your doctor. Vision loss in babies: Because of the risk of vision loss, Sabril is used in babies (1 month to 2 years old) with infantile spasms (IS) only when you and your doctor decide that the possible benefits of Sabril are more important than the risks. Parents or caregivers are not likely to recognize the symptoms of vision loss in babies until it is severe. Doctors may not find vision loss in babies until it is severe. It is difficult to test vision in babies, but all babies should have their vision tested before starting Sabril or within 4 weeks after starting Sabril, and every 3 months after that until Sabril is stopped. Your baby should have a vision test after Sabril is stopped. Your baby may not be able to be tested in certain situations. Your doctor will determine if your baby can be tested. SABRIL is only available through pharmacies that are enrolled in the SHARE REMS Program. As part of the SABRIL REMS Program, it is recommended that your healthcare provider test you (or your child’s) vision from time.
Tell your doctor right away if you think that your baby is: not seeing as well as before taking Sabril acting differently than normal. Even if your baby's vision seems fine, it is important to get regular vision tests because damage can happen before your baby acts differently. Even these regular vision exams may not show the damage to your baby's vision before it is serious and permanent. If your baby does not have these vision tests regularly, your doctor may stop prescribing Sabril for your baby. If your baby is not able to complete vision testing, your doctor may continue prescribing Sabril for your baby. But, your doctor will not be able to watch for vision loss in your baby. In all people who take Sabril: You are at risk for vision loss with any amount of Sabril Your risk of vision loss may be higher the more Sabril you take daily and the longer you take it. It is not possible for your doctor to know when vision loss will happen. It could happen soon after starting Sabril or any time during treatment. It may even happen after treatment has stopped. Because Sabril might cause vision loss, it is available to doctors and patients only under a special program called SHARE. As part of the SHARE program, among other things, your doctor will have to test your or your baby's vision frequently while you or your baby are being treated with Sabril, and even after you or your baby stops treatment. You also have to agree to be in the SHARE program, and agree to have your or your baby's vision tested regularly. Your doctor will explain the details of the SHARE program to you. Magnetic resonance imaging (MRI) changes: Brain pictures taken by magnetic resonance imaging (MRI) show changes in some babies after they are given Sabril. It is not known if these changes are harmful. Risk of suicidal thoughts or actions: Like other antiepileptic drugs, Sabril may cause suicidal thoughts or actions in a very small number of people, about 1 in 5. Call a doctor right away if you have any of these symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dyingattempts to commit suicidenew or worse depressionnew or worse anxietyfeeling agitated or restlesspanic attackstrouble sleeping (insomnia)new or worse irritabilityacting aggressive, being angry, or violentacting on dangerous impulsesan extreme increase in activity and talking (mania)other unusual changes in behavior or mood. Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes. Watch for early symptoms of suicidal thoughts and actions: Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. Sabril is approved to treat complex partial seizures and infantile spasms. Patients must also be enrolled in the SHARE program. Andrew Wilner discusses the FDA's approval of vigabatrin (Sabril. While the SHARE program provides heightened supervision. Keep all follow- up visits with your doctor as scheduled. Call your doctor between visits as needed, especially if you are worried about symptoms. Do not stop Sabril without first talking to a healthcare provider. Stopping Sabril suddenly can cause serious problems. Stopping a seizure medicine suddenly can cause seizures that will not stop (status epilepticus) in people who are being treated for seizures. Sabril can be prescribed only to people who are enrolled in a program called SHARE. Before you or your baby can begin taking Sabril, you must read and agree to all of the instructions in the SHARE program.
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