jueves, 23 de junio de 2016

FDA Approves Sabril (vigabatrin) REMS Modifications - Drug Information Update

Approved Risk Evaluation and Mitigation Strategies (REMS)

FDA Approves Sabril (vigabatrin) REMS Modifications - Drug Information Update

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The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.
On June 21, 2016, the FDA announced the approval of a supplemental New Drug Application (sNDA) modifying the REMS for Sabril. The FDA determined that, although the risk of vision loss with Sabril still exists, the REMS should be modified to remove certain elements.
Sabril was approved with a risk evaluation and mitigation strategy (REMS) to ensure that the benefits of Sabril outweigh the risks of vision loss and of suicidal thoughts and behaviors. Sabril can cause permanent bilateral concentric visual field constriction, including tunnel vision that can result in disability. In some cases, it also can damage the central retina and may decrease visual acuity.  Since approval, the REMS has required periodic visual monitoring results to be documented through submission of ophthalmologic assessment forms (OAFs).
The FDA has determined that requiring submission of OAFs as an element of the REMS is no longer necessary to ensure the benefits of Sabril outweigh its risks. Prescribers should continue to follow the vision monitoring recommendations described in the prescribing information for Sabril. 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.
The FDA is also modifying the REMS to remove additional education requirements about the risk of suicidal thoughts and behaviors because this risk is adequately communicated in the Warnings and Precautions section and the Medication Guide of the current FDA-approved prescribing information.
In addition, the FDA is eliminating the patient registry as an element of the REMS because the related postmarketing study, which is a postmarketing requirement (PMR), is a better mechanism for further characterizing and assessing the risk of vision loss associated with Sabril.
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.
For more information, please visit: Sabril.

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