Risk Evaluation and Mitigation Strategy Modified for Infantile Spasm Drug

The risk evaluation and mitigation strategy (REMS) for vigabatrin (Sabril) has been adjusted to remove certain elements.

Sabril may be used as monotherapy for infants aged 1 month to 2 years who experience infantile spasms. It may also be used in combination with other treatments for refractory partial complex seizures in patients aged 10 years and older who have not responded well to other therapies.

When Sabril was approved in 2009, a REMS was added to make sure that its benefits outweighed its risks. The REMS noted that Sabril can lead to vision loss and suicidal thoughts and behaviors.

Sabril affects the vision by causing permanent bilateral concentric visual field constriction, including tunnel vision. In June 2016, the FDA announced that it had approved a supplemental new drug application to modify Sabril’s REMS.

The REMS had required periodic monitoring to be completed through ophthalmologic assessment forms (OAFs). However, now the FDA believes the submission of OAFs is no longer necessary to weigh the risks and benefits.

“Prescribers should continue to follow the vision monitoring recommendations described in the prescribing information for Sabril,” the FDA explained in a press release. “As a condition of certification in the REMS, prescribers must agree to ensure that periodic visual monitoring is conducted as described in the product label, but they will no longer be required to submit OAFs as a part of the REMS.”

Additionally, the FDA intends to remove education requirements about the risks of suicidal behavior and tendencies associated with Sabril. The FDA determined that these potential risks are adequately detailed in the warnings and precautions section of Sabril’s accompanying guide, as well as the in the medication guide on prescribing information.

The FDA has also eliminated the patient registry as a part of the REMS because postmarketing studies are better at assessing the risk of vision loss.

“Finally, the REMS is being modified to allow for inpatient pharmacy certification in order to alleviate delays in initiating treatment with Sabril and interruptions in treatment during hospitalizations,” the FDA added.

Pharmacies and prescribers still must be specially certified in order to prescribe or dispense Sabril.

“The pharmacy enrollment form has been revised to provide a clear pathway for inpatient pharmacies to become certified,” The FDA stated in a press release. “This action is intended to alleviate delays in initiating treatment and to allow for the continuation of treatment with Sabril during a patient’s hospitalization.”

Patients must also sign an agreement form in order to be enrolled in the Sabril REMS program. They must acknowledge that they have been informed of the risk of vision loss and the need for periodic monitoring based on the recommendations in the prescribing information.