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This safety information outlines important considerations and potential risks associated with the use of Vigabatrin (Sabril). It is crucial to follow these guidelines and consult your healthcare provider with any questions or concerns.

• Vision Problems: Vigabatrin can cause permanent vision loss, including blurred vision and tunnel vision. These issues can arise at any point during treatment and may worsen even after stopping the medication. Regular eye exams are necessary: before or within 4 weeks of starting the treatment, every 3 months during treatment, and 3 to 6 months after discontinuation. Promptly report any vision changes to your doctor, such as blurred or double vision, loss of vision, light sensitivity, or eye pain. Participation in the REMS Program is required in the U.S., and similar regulations may apply in other countries.

• Abnormal Brain MRI in Children: In children 6 years old or younger, Vigabatrin may cause abnormal MRI findings due to nerve swelling in the brain. While these changes typically resolve after stopping the medication, some cases persist. Consult your child's healthcare provider about alternative treatments if needed. This issue is not common in older children or adults.

• Risk of Suicidal Thoughts: Vigabatrin can increase the risk of suicidal thoughts or behaviors, which might occur as early as one week after starting the medication. Seek immediate medical attention if you or someone around you notices signs of anxiety, panic attacks, irritability, or unusual behavior.

• Withdrawal Seizures: Do not stop Vigabatrin suddenly, as it can lead to the recurrence of seizures. Consult your healthcare provider for a plan to gradually reduce the dosage.

• Anemia: Vigabatrin may lead to low red blood cell counts (anemia). Your healthcare provider may conduct blood tests before and during treatment. Report symptoms like fatigue, weakness, pale skin, or shortness of breath.

• Drowsiness and Concentration Issues: The medication can cause dizziness, tiredness, and difficulty concentrating. Use caution when driving or performing tasks requiring alertness, especially if combined with alcohol or other sedatives. Inform your provider if these symptoms are severe.

• Nerve Pain in Adults: Some adults may experience peripheral neuropathy, characterized by numbness, tingling, or pain in the feet. Report any abnormal sensations to your healthcare provider.

• Weight Gain: Weight gain is possible, more frequently in children, but also in adults. Notify your provider if significant weight gain occurs.

By adhering to these guidelines, you can manage the risks associated with Vigabatrin and ensure safer use of the medication.

When taking this medication, some common side effects may include headache, dizziness, tiredness, drowsiness, and symptoms similar to a common cold. These effects are generally mild but if they persist, it’s advisable to consult a healthcare provider. Additional common side effects can be blurred vision, nausea, diarrhea, and joint pain, which may be experienced to a lesser extent. Some individuals might also notice weight gain, eye twitching, or abnormal coordination, though these are less frequent.

In some cases, more serious side effects can occur, such as uncontrolled shaking, swelling of ankles or feet, tingling or numbness, and a fast heartbeat. A small number of individuals might experience mental health changes including depression or suicidal thoughts. It's crucial to seek medical attention if you or those around you notice any significant changes in mood or behavior.

While rare, severe allergic reactions are possible, with symptoms like rash, severe dizziness, trouble breathing, or swelling of the face, tongue, or throat. If any of these occur, immediate medical assistance is required. Other serious side effects, though uncommon, include infections like upper respiratory tract infections or middle ear infections, along with fever, vomiting, and irritable behavior. Always report any severe or unusual side effects to a healthcare provider.