Belviq
What is Belviq?
The generic name for Belviq is lorcaserin. This costly medication is prescribed to promote weight loss and help maintain it in obese individuals. A low-calorie diet and exercise (if appropriate) are recommended to go along with the medication. Belviq is also prescribed for people who have weight-related health issues such as type 2 diabetes, high blood pressure or high cholesterol.
Belviq is classified as a serotonin-receptor agonist drug. It affects appetite by targeting certain chemicals within the brain. The medication comes in two forms. One is the Belviq tablet, and the other is the Belviq XR extended-release tablet.
Belviq Side Effects
A number of side effects are connected with Belviq. Among the potentially serious ones are:
- Feelings of standing beside yourself or being “out of body”
- Thoughts of hurting yourself, or feeling suicidal
- Unusual changes in behavior or mood
- Blurred vision, dry eyes
- Trouble concentrating, memory issues
- Penis erection that lasts more than 4 hours or is painful
- Breast swelling, nipple discharge
- Heart issues that produce symptoms like trouble breathing, fast heart rate, dizziness, ongoing weakness, swelling in hands, arms, legs or feet
- High amounts of serotonin in the body that produce hallucinations, agitation, fast heart rate, fever, nausea, diarrhea, vomiting, overactive reflexes, fainting, loss of coordination
- Serious nervous system reactions like high fever, sweating, rigid muscles, confusion, tremors, uneven or fast heartbeats, feeling like passing out
Some of the less severe Belviq side effects are:
- Dry mouth
- Cough
- Nausea
- Fatigue
- Drowsiness
- Dizziness
- Headache
- Mental problems
- Slow heartbeat
- Low blood sugar
Previous Approval of Belviq Denied by FDA
Belviq’s makers sought approval from the FDA for a number of years before being given the green light to market the drug in 2012. Back in October 2010, the government agency rejected the drug after reports linked Belviq to cancer in animals. Studies were produced showing that rodents had a greater risk of developing breast cancer and brain tumors (astrocytoma) after taking doses seven times stronger than a human would take. These experiments additionally showed that rats given Belviq had more heart valve damage than ones given a placebo.
The FDA was assured by the drug manufacturer that the tumors were not applicable to humans, because the tumors were specific to rodents. Ultimately, the FDA gave approval for Belviq in June 2012, but demanded that an additional study be conducted.
Linked to Cancer
When approving lorcaserin in 2012, the FDA required Eisai (the manufacturer) to conduct a double-blind, randomized, placebo-controlled clinical trial to determine the risk of heart issues. Approximately 12,000 individuals participated in the trial over a five-year period.
The results showed that more people taking the drug lorcaserin developed cancer than those taking a placebo, which is simply an inactive substance having no actual medicinal qualities. A number of various cancer types developed in lorcaserin users, with certain types occurring more frequently, like lung, colorectal and pancreatic.
The FDA notified consumers of the clinical trial results that demonstrated a potentially higher risk for cancer in individuals taking Belviq and Belviq XR. The agency announced on February 14, 2020 that it had not conclusively determined that lorcaserin is the cause of the cancer risk. However, it wants to bring awareness to the public of the potential cancer risk that does exist. The FDA has now determined it is in the best interests of the public to request the removal of Belviq from the market altogether.
Cancer Types Linked to Belviq
- Colon cancer
- Breast cancer
- Lung cancer
- Colorectal cancer
- Pancreatic cancer
Clinical Trial Data Regarding Belviq
The FDA studied the data produced by the lorcaserin clinical study trial that took place from January 2014 to June 2018. The study population included 12,000 men and women in Canada, the Bahamas, Mexico, South America, Europe, New Zealand, Australia and the U.S. All participants were considered overweight or obese.
Additionally, all participants were required to:
- Have established cardiovascular disease, or
- Be 50 years old if male/55 years old if female, and have type 2 diabetes mellitus, along with an added cardiovascular risk factor
Each participant was randomly assigned to either receive a placebo twice daily or lorcaserin 10 mg twice daily. About 96 percent of the participants finished the full study, and more than half of these individuals stayed on the treatment plan when the study ended. Median follow-up was done 3 years and 3 months afterward. The initial safety analysis did not reveal any meaningful difference in lorcaserin and the placebo when determining the risk of critical adverse cardiovascular events, thus demonstrating non-inferiority.
Belviq Recalled
The FDA issued a warning in February 2020 asking the maker of both forms of Belviq to voluntarily recall the drug when studies revealed an unacceptably high risk of cancer. The manufacturer, Eisai, said it will “voluntarily withdraw from the market and discontinue sales” in the U.S. This statement came in the form of an email to CNN. The director of the Center for Drug Evaluation and Research at the FDA, Janet Woodcock, released a statement in which she said, “Potential risk of cancer associated with the drug outweighs the benefit of treatment.”
What Should Physicians and Patients Do?
The FDA issued important directions on the actions that should be taken by the public.
Health Care Professionals
Prescribing and dispensing of lorcaserin should cease. Patients who are currently taking the medication should be contacted and informed of the increased number of cancer occurrences found in the clinical trial. These patients should be asked to cease taking the drug. Discuss other weight-loss strategies and medications with them.
There is no special screening recommended by the FDA for individuals who have taken the medication. Of course, standard recommendations for screening should be implemented, as would be done for any individual patient.
Patients
All patients taking lorcaserin should immediately stop and speak with their health care provider about alternative weight management programs and weight-loss medications. Dispose of any remaining lorcaserin at a proper “drug-take-back” location. If none is available, dispose of the drug in the household trash by doing the following:
- Using an unappealing substance like used coffee grounds, cat litter or dirt, mix in the pills, but don’t crush them.
- Next, put this mixture into a sealable plastic bag.
- Throw away this sealed bag in the household trash.
- Remove or obscure personal information on the empty prescription bottle, then recycle it or throw it away.
Contact Our Belviq Cancer Lawyers
The legal professionals at The Eichholz Law Firm are highly skilled at litigating for individuals who have been harmed by dangerous drugs. We are able to:
- Identify harmful and potentially dangerous medicines, whether prescribed or purchased over the counter
- Determine if the medication was harmful to you
- Research the drug maker’s compliance with FDA regulations
- Determine if you were adequately warned about possible side effects
- Identify any wrongdoing or illegal actions by the manufacturer
- Discover any other issues that might affect your claim
The attorneys at The Eichholz Law Firm do not think pharmaceutical companies should be allowed to pass dangerous and unsafe medications to the unsuspecting public without consequence. We have successfully represented numerous clients who were harmed by such negligence. Call us if you believe Belviq is the reason you’ve been diagnosed with cancer.
References
- FDA. “FDA requests the withdrawal of the weight-loss drug Belviq, Belviq XR (lorcaserin) from the market”, U.S. Food & Drug Administration, https://www.fda.gov/drugs/drug-safety-and-availability/fda-requests-withdrawal-weight-loss-drug-belviq-belviq-xr-lorcaserin-market. Accessed February 20, 2020.
- FDA. “Safety clinical trial shows possible increased risk of cancer with weight-loss medicine Belviq, Belviq XR (lorcaserin)”, U.S. Food & Drug Administration, https://www.fda.gov/drugs/drug-safety-and-availability/safety-clinical-trial-shows-possible-increased-risk-cancer-weight-loss-medicine-belviq-belviq-xr. Accessed February 20, 2020.
- Linda A. Johnson. “Weight Loss Drug Belviq Pulled From Market Over ‘Slight’ Cancer Risk”, Time, https://time.com/5784701/belviq-pulled-market-cancer-risk/. Accessed February 20, 2020.
- Shelby Lin Erdman and Theresa Waldrop. “Drugmaker Eisai to withdraw weight loss drug Belviq after trials find cancer link”, CNN, https://www.cnn.com/2020/02/13/health/belviq-weight-loss-drug-cancer-fda/index.html. Accessed February 20, 2020.