Belviq

  • Belviq-Medical-Record-Review-&-Outsourcing-Services

Lorcaserin is a prescription weight loss drug developed to treat obesity, approved by the Food & Drug Administration (FDA) in 2012, marketed under the brand name Belviq. Belviq was developed by Arena Pharmaceuticals. However, the rights to the drug were sold to the Japanese drugmaker, Eisai Inc., in 2017, and Eisai continued to manufacture the drug for U.S. consumption until the FDA-recommended recall in February 2020.

The drug activates a serotonin receptor known as a 5-HT2C receptor in a region of the brain called the hypothalamus, which reduces appetite.

The manufacturers applied for a new drug application regarding Belviq to FDA in the United States on December 22, 2009. The proposal was rejected by the FDA panel on October 23, 2010, considering the cancer-promoting properties that Belviq contains. Later, the FDA approved Belviq on June 27, 2012. Later in 2016, the FDA also approved an extended-release version of Belviq named Belviq XR.

Dangerous Side Effects:

  • Easy bleeding or bruising
  • Mental or mood changes
  • Difficulty with memory or concentration
  • Unusual agitation
  • Shaking or twitching muscles
  • Changes in heart rate
  • Unexplained fever
  • Swelling of the hands, feet, or ankles
  • Shortness of breath
  • Breast swelling and unusual breast milk discharge
  • Erections lasting 4 hours or more

Serious Alleged Injuries may include:

  • Lung cancer
  • Colorectal cancer
  • Pancreatic cancer

FDA Safety Warnings:

June 2012: Consumer watchdog group Public Citizen issued a statement warning that the drugmaker was ignoring important safety measures and predicted that Belviq would be recalled within a few years.

June 27, 2012: FDA approved Belviq to treat some overweight or obese adults. The drug was approved for use in adults with a body mass index (BMI) of 30 or greater (obese), or adults with a BMI of 27 or greater (overweight) and who have at least one weight-related condition such as high blood pressure (hypertension), type 2 diabetes, or high cholesterol (dyslipidemia).

February 13, 2020: The FDA issued a safety communication requesting Eisai Inc. to voluntarily recall Belviq. The recall was based on a clinical study that showed an increase in the occurrence of certain cancers among Belviq users.

Legal Updates:

Defendants:

Eisai Co., Ltd.

Arena Pharmaceuticals, Inc.

Defendant Law Firm:

Eisai Co., Ltd. Is represented Morris, Nichols, Arsht & Tunnell LLP

Arena Pharmaceuticals, Inc. Is represented by Cooley LLP

Allegations:

Allegations include the drug maker Eisai Co. withheld important safety information about the cancer risks from Belviq and provided false and misleading information about the safety of the drug for years.

Lawsuit Status:

Belviq lawsuits are in its early stages. Claims are expected to seek reimbursements for the premium price paid by users of the recalled diet drug, as well as funding for medical monitoring that users may require to detect cancer that may surface months or even years after last exposure.

MDL Status: Not yet formed

Important Verdicts & Settlements: Though lawyers are taking cases, there have been no verdicts or major settlements yet.

Evidence:

  • Duration of Usage
  • Indication of usage in Medical Records
  • Evidence of injury in follow up medical records

Medical Record Review and claim validation of Belviq case should take approximately 3 hours in most instances; however, this approximation may vary in cases based on the volume of records.

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