FDA Agrees to "Expanded Access" Program for the Drug
Written by: Lauren Schwab, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
Since its approval by the FDA in 2019, Belviq has been used to treat obesity. The drug had also commonly been used to treat Dravet Syndrome, also known as Severe Myoclonic Epilepsy of Infancy (SMEI), which is a rare form of intractable epilepsy that begins in infancy. It is common for physicians to prescribe medication for "off-label" use for rare diseases such as Dravet Syndrome.
Belviq Taken Off the Market, With Some Exceptions
On February 13, 2020, the FDA announced Eisai, the drug manufacturing company for Belviq, agreed to withdraw the drug from the U.S. market due to clinical trial results that showed an increased risk of cancer associated with Belviq. According to a February 2, 2020, Drug Safety Communication released by the FDA:
When FDA approved lorcaserin in 2012, we required the drug manufacturer to conduct a randomized, double-blind, placebo-controlled clinical trial to evaluate the risk of cardiovascular problems, which found that more patients taking lorcaserin (n=462; 7.7 percent) were diagnosed with cancer compared to those taking a placebo, which is an inactive treatment (n=423; 7.1 percent). The trial was conducted in 12,000 patients over 5 years. A range of cancer types was reported, with several different types of cancers occurring more frequently in the lorcaserin group, including pancreatic, colorectal, and lung.
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Many Dravet Syndrome patients became concerned regarding the removal of Belviq from U.S. markets, however, the Dravet Syndrome Foundation said in a February 2020 statement that they have worked alongside Eisai to make an exception for Dravet Syndrome patients:
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.
The Future of Belviq for Dravet's Syndrome Patients
Following the Dravet Foundation's work with Eisai, the FDA agreed to an "Expanded Access" program in order to allow for continued use of Belviq for Dravet Syndrome patients, despite the recent withdrawal from the market as an obesity drug. According to a February 2020 statement by the Dravet Foundation:
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.
For people with possible Belviq lawsuits -- personal injury or wrongful death -- we encourage them to submit a Belviq Case Evaluation Form. It is free, confidential, and there is no obligation.
Of course, we will continue to monitor the medical research for more information about the specific types of cancer cases associated with Belviq.