Belviq Cancer Lawsuit Attorney
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The weight loss drug Belviq was recalled on February 13, 2020 by the by the Food and Drug Administration (FDA). This product was placed on the market in 2012 and came out with an extended release version in 2016 for people attempting long term weight management. The withdraw occurred as a result of clinical trials which showed a link between the drug and cancer.
Belviq was intended to treat those people with a BMI (body mass index) of 30 or greater or 27 BMI combined with a condition related to weight such as high blood pressure, type 2 diabetes or high cholesterol. The initial approval came following three clinical trials with less than 8,000 patients and increased their average weight loss to a little over 3%. Belviq and Belviq XR are manufactured by the Japanese drug company, Eisai Inc., and were often prescribed by physician weight loss clinics that used these drugs in conjunction with other modalities to assist patients lose weight.
HOW IS BELVIQ LIKE FEN-PHEN?
The active ingredient in Belviq is lorcaserin, which works with brain serotonin receptors to trick people to feel full after they have eaten a smaller amount of food than usual, which in turn causes them to take in less calories. These serotonin receptors were the same hormone that were targeted in the infamous fen-phen drugs in the 1990s. Fen-phen was also pulled from the market after its use related to damage to the patient’s heart valve after being on the market for less than 18 months.
BELVIQ ORIGINALLY REJECTED
In 2010 an FDA Advisory Committee held a meeting and heard from the manufacturers of the Belviq and other parties. Following that meeting, Belviq was informed that it would not be approved because of a failure of data regarding the occurrence of cancer in rats used in testing. There was also adenocarcinoma found in the rats and the concern was whether this could be translated to the humans that took the drug.
Finally, the FDA in 2010 was not impressed with the weight loss results in patients and requested more studies to show Belviq’s effectiveness and a determination if the downside to the drug was worth the benefits that it might give a patient.
Eisai took a second shot at the FDA in 2012 and resubmitted their application. This time, the FDA supported the application but required the company to do long term studies to ensure that there was no evidence of damage to the heart like Fen-Phen had caused. On June 27, 2012 Belviq was approved for marketing in the United States. However, the European Medicines Agency did not approve Belviq and the company withdrew its application for approval. This withdraw came after the agency became concerned about the connection with the drug and tumors.
On July 19, 2016, the FDA approved Belviq XR, an extended release version of Belviq.
STUDIES SHOW LINK TO CANCER
The requirement of long term studies resulted in approximately 12,000 people being evaluated. In June of 2018 the results of those studies revealed a link between Belviq and cancer. This caused the FDA to issue a safety communication on January 14, 2020 in which it warned of the connection between the drug and cancer along with a statement that it would continue to evaluate. Less than a month later, on February 13, 2020, the FDA recalled both Belviq and its long term release version Belviq XR because of the greater exposure to cancer for its users than those in the study taking the placebo. These include links to pancreatic cancer, colorectal cancer and lung cancer.
STOP TAKING BELVIQ
The FDA, in addition to the withdraw of the drug, has told people to consult their doctors and to STOP taking the weight loss drug. They have also recommended that people discuss alternative weight loss drugs.
Have You Taken Belviq and been diagnosed with Cancer?
If you have taken the weight loss drug Belviq and been diagnosed with pancreatic, colorectal or lung cancer contact the Keith Law Group for more information.
LET US HELP YOU MOVE ON WITH YOUR LIFE
At Keith Law Group, we have the knowledge and resources needed to secure full and fair compensation for your losses. When you hire us, we will take swift action to investigate your case and preserve critical evidence in your case. Our lawyers will pursue an aggressive case strategy designed to win maximum compensation as quickly as possible.