It is not uncommon in a rare disease like Dravet syndrome (DS) to have a physician prescribe a medication for “off-label” use by their patient. This means that the drug is not being used in the manner specified in the FDA’s approved package labeling and is being used for a disease that it is not approved to treat. A physician may decide to prescribe a medication off-label when there is not an approved drug to treat a disease, or it may be that the patient has exhausted all approved treatment options without seeing any benefits. Some members of our patient community began taking Belviq (lorcaserin) off-label, after reports that it potentially helped with seizure control, even though it received FDA approval as a weight-loss drug.
On Thursday, February 13, 2020, Eisai voluntarily withdrew Belviq from the market at the request of federal regulators. A recently completed Food and Drug Administration (FDA) analysis of the data from that study showed 7.7% of participants who took Belviq were diagnosed with cancer, slightly more than the 7.1% who developed cancer in a comparison group given dummy pills. However, Eisai said in a statement that it disagreed with the FDA’s interpretation of new data on the drug’s safety and still believes Belviq’s benefit outweighs the risk.
This abrupt withdrawal has caused concerns and challenges for patients with Dravet syndrome who take Belviq off-label. DSF Scientific Director, Nicole Villas, along with our Medical Advisory Board reached out to Eisai on behalf of DSF and our community. Eisai heard these concerns and spoke with the FDA about continuing to supply Belviq to patients with Dravet syndrome who benefit from this medication. Eisai and the FDA have agreed to proceed with expanded access for Belviq (lorcaserin) for Dravet syndrome patients. Physicians with patients on Belviq can reach out to Eisai at firstname.lastname@example.org for information on how to enroll their patient in the centralized Expanded Access program.