{"id":9056,"date":"2020-02-19T16:46:54","date_gmt":"2020-02-19T21:46:54","guid":{"rendered":"https:\/\/www.singlecare.com\/blog\/?p=9056"},"modified":"2020-07-10T13:43:13","modified_gmt":"2020-07-10T17:43:13","slug":"belviq-fda-market-withdrawal","status":"publish","type":"post","link":"https:\/\/www.singlecare.com\/blog\/news\/belviq-fda-market-withdrawal\/","title":{"rendered":"Weight-loss drug Belviq withdrawn from U.S. market amid concerns it raises cancer risk"},"content":{"rendered":"<p><span style=\"font-weight: 400;\">On Feb. 13, <\/span><a href=\"https:\/\/www.eisai.com\/index.html\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">Eisai<\/span><\/a><span style=\"font-weight: 400;\">, the makers of the weight-loss drug <\/span><a href=\"https:\/\/www.belviq.com\/pdfs\/Belviq_Prescribing_information-pdf.pdf\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">Belviq<\/span><\/a><span style=\"font-weight: 400;\"> and <\/span><a href=\"https:\/\/www.singlecare.com\/prescription\/belviq-xr\"><span style=\"font-weight: 400;\">Belviq XR<\/span><\/a><span style=\"font-weight: 400;\"> (<\/span><span style=\"font-weight: 400;\">lorcaserin HCI), voluntarily withdrew the drug from the U.S. market at the request of the <\/span><a href=\"https:\/\/www.fda.gov\/drugs\/drug-safety-and-availability\/safety-clinical-trial-shows-possible-increased-risk-cancer-weight-loss-medicine-belviq-belviq-xr\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">U.S. Food and Drug Administration (FDA)<\/span><\/a><span style=\"font-weight: 400;\">. Belviq is a prescription medication, available as a tablet and an extended-release tablet. It increases feelings of fullness to help patients eat less and lose more weight, especially when used along with diet and exercise. The FDA approved Belviq in 2012 for adults who are obese; or who are overweight and have weight-related medical problems, such as diabetes, high blood pressure, or high cholesterol.\u00a0<\/span><\/p>\n<h2><span style=\"font-weight: 400;\">Why did the FDA ask for Belviq\u2019s withdrawal?<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">As part of Belviq\u2019s marketing approval, the FDA required Eisai to perform a long-term trial examining whether the drug produced any cardiovascular problems in users. The study lasted five years and looked at 12,000 users with cardiovascular disease and\/or a high risk of developing cardiovascular disease. It found that the drug did, indeed, help users lose weight without producing any major heart problems.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">But in reviewing the data, the FDA found that people taking Belviq had a higher incidence of cancer than those who didn\u2019t take the drug. According to the FDA\u2019s analysis, 7.7% of Belviq users were diagnosed with cancer during the study period, versus 7.1% of those in the control group who were taking a placebo (inactive pill that did not contain any drug). Types of cancer included pancreatic, colorectal, and lung cancer. While the company says its interpretation of the data differs from the FDA\u2019s, the FDA says the risks of using Belviq outweigh its benefits.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u201c<\/span><span style=\"font-weight: 400;\">Eisai respects the FDA&#8217;s decision and is working closely with the Agency on the withdrawal process,\u201d the company said in a <\/span><a href=\"http:\/\/eisai.mediaroom.com\/2020-02-13-Eisai-to-Voluntarily-Withdraw-BELVIQ-R-BELVIQ-XR-R-in-the-U-S\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">statement<\/span><\/a><span style=\"font-weight: 400;\">.<\/span><\/p>\n<h2><span style=\"font-weight: 400;\">What should Belviq users do?<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">The FDA cautions users to stop taking Belviq immediately and discuss other weight-loss methods with their doctors. Belviq works differently than some other weight-loss medications on the market, so it\u2019s possible your doctor may advise using a different medication or recommend diet and exercise alone.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">To dispose of unused Belviq properly, bring the medication to a <\/span><a href=\"https:\/\/www.singlecare.com\/blog\/how-to-get-rid-of-unused-medicine\/\"><span style=\"font-weight: 400;\">drug take-back location<\/span><\/a><span style=\"font-weight: 400;\">. If that isn\u2019t possible, the FDA recommends you dispose of Belviq in the trash:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Take the medication out of the prescription bottle and mix it with an unappetizing substance\u2014for example, cat litter or used coffee grounds. Do not crush the tablets.<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Place the medication mixture into a sealed plastic bag.<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Throw the container away with your household garbage.<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Remove your identification from the prescription bottle and recycle it or throw it away as well.<\/span><\/li>\n<\/ul>\n<h2><span style=\"font-weight: 400;\">Do I need additional cancer screenings?<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">No. The FDA is not calling for any additional cancer screenings for Belviq users beyond what is already advised for the general public. \u201cUsers should not be alarmed,\u201d says <\/span><span style=\"font-weight: 400;\">Shaili Gandhi, Pharm.D., vice president of formulary operations at SingleCare. \u201cPatients should speak to their doctors about any questions or concerns they may have. The discussion should include alternative medication options and methods for weight loss.\u201d<\/span><span style=\"font-weight: 400;\">\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Patients or healthcare providers can report any issues to the FDA&#8217;s MedWatch Safety Information and Adverse Event Reporting Program by <\/span><a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/medwatch\/index.cfm\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">submitting an online report<\/span><\/a><span style=\"font-weight: 400;\"> or by calling 1-800-332-1088.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>On Feb. 13, Eisai, the makers of the weight-loss drug Belviq and Belviq XR (lorcaserin HCI), voluntarily withdrew the drug from the U.S. market at the request of the U.S. Food and Drug Administration (FDA). Belviq is a prescription medication, available as a tablet and an extended-release tablet. It increases feelings of fullness to help [&hellip;]<\/p>\n","protected":false},"author":85,"featured_media":9067,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[4589,4114],"tags":[72,8905],"coauthors":[10462],"class_list":["post-9056","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-drug-info","category-news","tag-fda","tag-seasonal","wpautop"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.4 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>FDA market withdrawal: Weight-loss medication Belviq no longer sold in U.S.<\/title>\n<meta name=\"description\" content=\"Belviq\u2014a weight-loss drug\u2014was taken off the U.S. market due to a FDA market withdrawal request. 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