• Strong Law

FDA Requested Withdrawal Of Popular Weight-Loss Drug Belviq® From The Market

In early 2020, the FDA requested the withdrawal of a popular weight loss drug, Belviq® and Belviq XR®, from the U.S. Market amid safety concerns over the drug and the drug’s link to increased risk of several types of cancers, including pancreatic, colorectal and lung. The FDA’s request came after the conclusion of a 5-year clinical study involving 12,000 participants. According to the study results, patients taking Belviq® saw higher rates of certain cancers over those patients taking a placebo. Belviq® was first approved by the FDA in 2012, and was the first weight-loss drive approved by the FDA since 1999. It was only available by prescription, and was supposed to aid in weight loss of up to 5% of their weight during the first 12-weeks of use when coupled with a low-calorie diet and exercise.

Patients who are taking Belviq® (or its generic form, Lorcaserin) should immediately stop taking the drug and contact your physician, and dispose of any unused portion of the drug. It is recommended that you consult your healthcare providers immediately about alternative treatment options.

Since that time, Eisai, Inc. and Arena Pharmaceuticals, Inc which manufacture Belviq®. have faced lawsuits alleging product liability claims based upon design defect and defective manufacturing, as well as breach of express warranty. Eisai, while complying with the FDA’s withdrawal request, disagreed with the FDA’s interpretation of the study data, and maintains that Belviq® and Belviq XR® both continue to have a positive benefit-risk profile in patients who are indicated for the drugs’ use. As more patients who have a history of use Belviq® and Belviq XR® prior to the voluntary withdrawal face cancer diagnoses, it is projected that more lawsuits will be filed across the country in the US. Neither Belviq® or Belviq XR® is currently for sale in the US.

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