Did Patients Trade Weight Loss Concerns for Cancer Concerns? — BELVIQ
In February of 2020, an announcement was made that the weight loss drug lorcaserin (sold under brand names BELVIQ and BELVIQ XR) would be voluntarily withdrawn from the market in the United States due to concerns that the drugs might cause or promote cancer in patients. The FDA had also issued a safety alert on January 14, 2020, indicating concerns about a potential risk of cancer in patients using the drug and urging patients to consult with their prescribing doctors to determine whether the benefits of continued use of the weight loss drug were warranted, given these safety concerns. The FDA has also urged patients and their doctors to report any adverse events that might be associated with BELVIQ, as this adverse event data is critical in addition to the animal studies and clinical trial data in evaluating any potential cancer risk posed by the drug to patients.
The removal of BELVIQ from the market occurred after results were reported from a randomized, double-blind, placebo-controlled drug study (known as CAMELLIA-TIMI 61 Trial) that was ordered by the FDA to evaluate the risk of heart-related problems. This post-marketing clinical trial included approximately 12,000 patients from 400 centers in 7 countries evaluated over a five-year time period. These patients had either a history of cardiovascular disease or were at risk for heart disease. Data from this study indicated that patients taking BELVIQ had a higher incidence of cancer than study participants taking a placebo. The FDA’s recent review of data from this clinical study (noted as being the “largest cardiovascular outcome trial conducted to date for a weight loss medication”) noted that the potential risks of BELVIQ outweigh its benefits and there was a “numerical imbalance in the number of patients with malignancies” with 7.7% of the patients that ingested BELVIQ during the study being diagnosed with cancer versus 7.1% in the placebo group developing a malignancy during the study. The drug manufacturer has stated publicly that it disputes the FDA’s review of the cancer data and still contends that the benefits of the drug outweigh its benefits, but nevertheless agreed to pull its diet drug from the market.
A “voluntary withdrawal” by a drug company legally differs from a drug “recall” by the Food & Drug Administration. Most drugs and medical devices are “voluntarily withdrawn” to avoid the stigma of a formal recall by safety regulators. With this withdrawal from the market, BELVIQ and BELVIQ XR join a long list of other recalled and/or unsafe diet drugs linked to patient injuries including Aminorex (pulmonary hypertension), “fen-phen” and Redux (heart valve damage and pulmonary hypertension, phenylpropanolamine or PPA (stroke), rimonabant (suicide), and Meridia (stroke and heart attacks).
BELVIQ was approved by the Food & Drug Administration in 2012 after hearings and some back-and-forth between governmental regulators and the drug company relating to concerns about the efficacy of the drug and potential cancer risks. As often happens, the drugs were approved for use by unsuspecting patients while post-marketing clinical studies were conducted to further evaluate potential safety concerns. Unfortunately, most drugs are subjected to very limited testing in patients before being approved for sale, and those tests often are limited to patients that are healthier than the general population. Also, patients are pulled from studies if there are any potential signs of adverse effects from the drugs. Because of this process, it is not uncommon for safety issues to not be fully identified and understood until after a drug has been prescribed to many thousands of patients.
An application to the FDA to approve BELVIQ (lorcaserin) was submitted by Arena Pharmaceuticals on December 22, 2009. BELVIQ was part of a new class of drugs to be used in patients with a BMI greater than 30 or overweight patients with other risk factors (such as diabetes). The diet drugs were believed to impact the serotonin 2c receptor agonist in the brain, which are believed to control a patient’s appetite and metabolism.
According to the drug manufacturers, their application for BELVIQ was supported by 18 clinical trials involving nearly 9,000 patients, including two-year scientific studies of thousands of patients. In September of 2010, the FDA held an Advisory Committee Meeting where it heard testimony from the drug manufacturer, physicians, and others relating to approving the weight loss drug. In October of 2010, the FDA notified Arena Pharmaceuticals and Eisai Inc. that BELVIQ would not be approved due to concerns about insufficient data regarding the incidence of mammary and brain tumors in rats exposed to the drug and the need for a pathologist to examine animal tissue samples for mammary and lung cancerous and non-cancerous lesions. The drug approval denial was also based on insufficient information on the correlation, if any, between the adenocarcinoma noted in lab rats exposed to the drug and whether those results could be correlated to humans. Further, the FDA noted that the data showed only marginal weight loss in patients taking the drug and sought further studies substantiating the benefits of the drug. This is particularly important in drug safety evaluations (and lawsuits relating to defective or recalled drugs) since all pharmaceuticals carry risks for patients, such that the benefits of the drugs must outweigh the risks to patients.
Following the Advisory Committee Meeting, the FDA made further requests of the drug manufacturer for changes to the New Drug Application, which was amended and resubmitted on January 10, 2012. Following a second Advisory Committee Meeting on in early 2012 where the drug received a favorable vote, the FDA approved BELVIQ to treat obesity in adults on June 27, 2012. In 2013, an application for approval of BELVIQ in Europe was withdrawn by the drug company after safety regulators at the European Medicines Agency noted that the drug was unlikely to be approved for obese and overweight patients due to concerns over animal study data relating to cancer and the potential risk of developing tumors in patients using BELVIQ, especially on a long-term basis. Ultimately, European regulators decided in 2013 that the modest weight loss associated with the drug did not outweigh the potential risk of cancer. BELVIQ XR (an extended release version of lorcaserin) was approved by the FDA on July 19, 2016.
Eisai Inc. had the exclusive right to market and distribute lorcaserin in the United States since 2012 and took over complete control of the drug, including regulatory compliance and safety monitoring, in 2017. Before that, it was reported that sales of BELVIQ were lower than expected. Eisai is a global pharmaceutical company based in Japan with a United States headquarters in New Jersey. Eisai has existed over 75 years with over 10,000 employees and annual revenues of more than $600 billion. Arena Pharmaceuticals was founded in 1997 and is based in San Diego.
The drug and medical lawyers of Searcy Denney are investigating potential lawsuits involving use of BELVIQ and BELVIQ QR in patients who developed pancreatic cancer, colorectal cancer, and lung cancer while or after taking these diet drugs. Please contact our offices at 1-800-388-3905.