Belviq Was Withdrawn From Market Due to Increased Risk of Certain Cancers: Pancreatic, Colon, Rectal, And Lung

 

(Posted by Tom Lamb at Drug Injury Watch)

 

Recently we found some further FDA action regarding Belviq related to the 2020 Belviq recall which was due to an increased risk of cancer.  In the March 4, 2021 edition of the Federal Register, there was this February 26, 2021 Notice item, “Determination That BELVIQ (Lorcaserin Hydrochloride) Tablets, 10 Milligrams, and BELVIQ XR (Lorcaserin Hydrochloride) Extended-Release Tablets, 20 Milligrams, Were Withdrawn From Sale for Reasons of Safety or Effectiveness“. The Summary section of that 2021 Federal Register Notice states:

The Food and Drug Administration (FDA or Agency) has determined that BELVIQ (lorcaserin hydrochloride) tablets, 10 milligrams (mg), and BELVIQ XR (lorcaserin hydrochloride) extended-release tablets, 20 mg, were withdrawn from sale for reasons of safety or effectiveness. The Agency will not accept or approve abbreviated new drug applications (ANDAs) for lorcaserin hydrochloride tablets, 10 mg and 20 mg.

In effect, according to that 2021 Federal Register Notice, this further FDA action regarding Belviq means:

[The FDA] will remove BELVIQ (lorcaserin hydrochloride) tablets, 10 mg, and BELVIQ XR (lorcaserin hydrochloride) extended-release tablets, 20 mg, from the list of drug products published in the Orange Book. FDA will not accept or approve ANDAs that refer to this drug product.

This February 2020 FDA Drug Safety Communication announcing the Belviq recall, “FDA requests the withdrawal of the weight-loss drug Belviq, Belviq XR (lorcaserin) from the market”, noted that excess cases of pancreatic cancer, colon cancer, rectal cancer, and lung cancer were observed. This Belviq recall has resulted in Belviq lawsuits being filed against the responsible pharmaceutical company, Eisai Inc.

The Data Summary section of the Belviq FDA Drug Safety Communication set forth these findings from the Belviq safety clinical trial:

Imbalances in specific cancers including pancreatic, colorectal, and lung contributed to the observed overall imbalance in cancer cases. There was no apparent difference in the incidence of cancer over the initial months of treatment, but the imbalance increased with longer duration on [Belviq (lorcaserin)].

According to the FDA, these are some of the specific types of cancer associated with Belviq:

  • Pancreatic Cancer
  • Colorectal Cancer
  • Colon Cancer
  • Rectal Cancer
  • Lung Cancer

Our law firm is investigating possible Belviq lawsuits where patients have been diagnosed with cancer, including but not limited to the types listed above.


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