Sabril REMS Update Ends OAF Requirement

Although requirements have been lifted, the FDA say vision loss still a risk
Although requirements have been lifted, the FDA say vision loss still a risk

The Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Sabril (vigabatrin; Lundbeck) tablets, meaning prescribers will no longer be required to submit an ophthalmologic assessment form (OAFs) as part of the risk evaluation and mitigation strategy (REMS).

Although OAF submissions will no longer be required, the updated REMS stipulates that prescribers should still continue to follow the vision monitoring recommendations detailed in the prescribing information. 

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The updated REMS also removes the additional education requirements about the risk of suicidal thoughts and behaviors, as this is already covered in the Warnings and Precautions section and Medication Guide.

Furthermore, the patient registry for Sabril has been eliminated and inpatient pharmacy certification has been approved. Registry was no longer deemed necessary due to the postmarketing study which is a better method of assessing the risk of vision loss associated with Sabril, while inpatient pharmacy certification should speed up treatment initiation.

Sabril is indicated as an adjunctive treatment for refractory complex partial seizures (CPS) in patients who have not responded to other treatments. In light of the REMS changes, the FDA stated that the risk of vision loss still exists.

For more information visit FDA.org.

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