What is the vigabatrin REMS Program?

The Vigabatrin Risk Evaluation and Mitigation Strategy (REMS) Program is a program intended to lessen the risk of vision loss caused by treatment with vigabatrin (Sabril, Vigadone, Vigpoder). It is a requirement of the drug’s approval by the US Food and Drug Administration (FDA) and helps make sure that the benefits of treatment with this medication outweigh the risk of vision loss associated with its use.

Vigabatrin is an antiepileptic or anticonvulsant drug used to treat epilepsy and infantile spasms. It is taken twice a day and comes as a tablet and oral solution.

What is the purpose of the vigabatrin REMS Program?

The Vigabatrin REMS program requires those prescribing, dispensing and receiving this medication to enroll in the program.

The program is used to make sure that healthcare providers prescribing this medication are aware of the:

• Risk of vision loss associated with vigabatrin
• Importance of talking to patients about the risks
• Need for periodic monitoring of patients for vision loss
• Need to report any events that indicate a patient may have vision loss

Prescribers enrolling in the program are required to review the prescribing information for vigabatrin, provide a copy of ‘What you need to Know About Vigabatrin Treatment: A Patient Guide’ to the patient, and complete the 'Patient/Parent/Legal Guardian - Physician Agreement Form'. They must also send prescriptions for this medication to a certified pharmacy to be dispensed.

The program is also used to ensure that pharmacies dispensing vigabatrin only give it to patients with the documents confirming they have been told about the risk of vision loss associated with this drug and the need for periodic monitoring of their vision.

A pharmacy wanting to dispense vigabatrin must enroll in the REMS program, provide the necessary training to staff and ensure its processes comply with the requirements of the program. Before a pharmacist dispenses this medication they must also verify that the prescriber is certified and the patient is enrolled in the program.

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Why is there concern about vision loss with vigabatrin?

Vigabatrin can cause permanent damage to your vision at any time while you are taking it and even after you have stopped taking it. Vision loss caused by vigabatrin will not get better.

Treatment with vigabatrin can damage your peripheral vision - your ability to see to the side when you’re looking straight ahead. If the damage is severe then you may develop what is called tunnel vision, where you can only see things directly in front of you. You may also develop blurry vision.

What are the symptoms of vision loss caused by vigabatrin?

You may not notice any loss of vision caused by vigabatrin until the damage is severe. Signs that your vision may have been damaged include:

• Inability to see to the side - loss of peripheral vision
• Your vision is blurred
• You don’t see as well as before starting treatment
• You are more clumsy than usual and trip and bump into objects
• Objects and people appear out of nowhere
• Acting differently than normal (for babies)

Does periodic vision monitoring prevent vision loss caused by vigabatrin?

Periodic vision testing, which is carried out by an ophthalmologist or optometrist, will not prevent vision loss, but it may detect it before you are aware of it. The results of your regular eye check-ups may help you decide whether or not you should continue treatment with vigabatrin.