VIGABATRIN ORAL (SABRIL) **SUICIDAL BEHAVIOR AND IDEATION Healthcare professionals should closely monitor all patients currently taking or starting any antiepileptic drug for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression. **USAGE IN PREGNANCY Patients should be encouraged to enroll in the NAAED Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll free number 1-888-233-2334. DISCOLORATION: FDA is warning the public that the anti-seizure medication Potiga (Ezogabine) can cause blue skin discoloration and eye abnormalities characterized by pigment changes in the retina. BOXED WARNINGS: WARNING: VISION LOSS See full prescribing information for complete boxed warning • SABRIL causes progressive and permanent bilateral concentric visual field constriction in a high percentage of patients. In some cases, SABRIL may also reduce visual acuity. • Risk increases with total dose and duration of use, but no exposure to SABRIL is known that is free of risk of vision loss • Risk of new and worsening vision loss continues as long as SABRIL is used, and possibly after discontinuing SABRIL • Periodic vision testing is required for patients on SABRIL, but cannot reliably prevent vision damage • Because of the risk of permanent vision loss, SABRIL is available only through a special restricted distribution program HOW MEDICINE IS ADMINISTERED? TOP Use this medicine exactly as directed on the label, unless instructed differently by your doctor WARNINGS/PRECAUTIONS: TOP * Safety of use during pregnancy has not been established. This medicine SHOULD NOT BE USED DURING PREGNANCY unless benefit justifies potential risk to the fetus. CALL YOUR DOCTOR. Other Common Side Effects: TOP Blurred vision; Weight gain; Anemia; Sleepiness; Abnormal vision; Numbness or tingling in hands and feet; Difficulty falling asleep; Mri abnormalities; ; Coordination difficulty; Confusion; Double vision; Depression; Diarrhea; Dizziness; Swelling of feet or lower legs; Unusual tiredness or weakness; Fever; Headache; Irritability; Flu; Joint pain; Memory difficulty; Nausea; Numbness or tingling of face or mouth; Nasopharyngitis; Pendular or jerky eye movement; Skin rash; Suicidal tendency; Increased risk of suicidal thoughts; Shakiness; Upper respiratory infection; Vision loss; Vomiting. Other Common Side Effects: If symptoms are mild but do not go away or are bothersome, check with your doctor. IF ANY OF THE ABOVE SIDE EFFECTS IS SEVERE, CALL YOUR DOCTOR IMMEDIATELY. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. This leaflet has been developed by CliniDATA Source, Inc. based primarily on labeling information provided by the manufacturer. The information does not cover all possible uses, actions, precautions, side effects, or interactions of this medicine. It is not intended as medical advice for individual patients. Copyright © CliniDATA Source, Inc. 03/14. All rights reserved