From the time the diet pill Belviq hit the market in 2012, there were hints that something might be amiss. Eight years later, studies would show the drug was linked to an increased occurrence of cancer.

Belviq was approved in 2012 as a long-term treatment for obese adults or overweight adults with at least one weight-related comorbidity, such as high blood pressure, type 2 diabetes, or high cholesterol. Studies on nearly 8,000 overweight patients who were treated with the drug for 52 to 104 weeks saw an average weight loss ranging from 3% to 3.7%.

The drug’s active ingredient is lorcaserin, a medication that works on the same appetite controlling hormone as fenfluramine, the “fen” in fen-phen, the weight loss drug cocktail pulled from the market in 1997 after less than a year and a half due to potentially life-threatening heart risks.

Despite this link, the U.S. Food and Drug Administration (FDA) agreed to approve the drug on the contingency that drug maker Eisai Inc., conduct long-term studies to evaluate heart risks. Those studies were completed in 2018.

On Jan. 14, 2020, the Food and Drug Administration (FDA) warned consumers that early data from those studies suggested people who used Belviq had a higher occurrence of cancer. A month later, on Feb. 13, 2020, the FDA issued another Safety Communication requiring the removal of Belviq from the market after evaluating the data. The agency said that the cancers most linked to Belviq use included pancreatic cancer, colorectal cancer and lung cancer.

But even before Belviq was approved, there were concerns. Cancer concerns.

In late 2009, Belviq was in the hands of Arena Pharmaceuticals. That company applied for FDA approval based on 18 clinical trials. An FDA Advisory Committee in October 2010 informed Arena and Eisai, which would take over all U.S. marketing and distribution of Belviq beginning in 2012, that it would not recommend approval of the drug based on studies of laboratory rats that developed mammary and brain tumors after being exposed to Belviq. The agency also raised red flags about whether there was a correlation between Belviq and adenocarcinoma in the lab rats and whether this could become an issue with humans. Adenocarcinoma is a type of cancer that begins in mucus-producing cells within the body and most often is seen in breast cancer, colorectal cancer, lung cancer, pancreatic cancer and prostate cancer.

Eisai regrouped and resubmitted the application for Belviq on Jan. 10, 2012, and on June 27, 2012, Eisai received approval from the FDA to market the drug in the U.S.

But in 2013, Eisai withdrew its application for Belviq approval with the European Medicines Agency after the agency indicated that it would not approve the diet pill based on concerns about the occurrence of cancer in laboratory rats that may translate to a cancer risk to humans, especially since Belviq was designed to be a long-term treatment.

This didn’t stop the U.S. FDA from granting approval on July 19, 2016, to Belviq XR, an extended release version of Belviq.

Roger Smith, Ryan Duplechin and Melissa Prickett, attorneys with Beasley Allen Law firm, are currently investigating cases of pancreatic cancer, colorectal cancer and lung cancer in patients who have been treated with Belviq.

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