BELVIQ is a weight loss drug. Other names it is known by include Lorcaserin and Lorqess, which were used during its developmental stage. This drug is designed to reduce your appetite with the activation of your serotonin receptor. This receptor is in the portion of your brain called the hypothalamus, which controls your appetite.
Medical Uses and Approval of BELVIQ
BELVIQ is prescribed as a long term weight loss if your doctor has labeled you as obese. In December of 2009, manufacturers of BELVIQ submitted an NDA (New Drug Application) to the FDA (Federal Drug Administration) in the U.S. It was un-approved by a vote of nine-to-five in September 2010 due to concerns over the drug’s safety and effectiveness. The use of the drug in laboratory tests showed it caused tumors in rats.
Obesity is a disease involving an extreme amount of body fat. This disease is not considered a cosmetic concern even though it significantly affects one's appearance. Obesity is regarded as a medical condition that heightens the risk of other diseases and health issues. Other health conditions that can result from obesity include; high blood pressure, certain cancers, diabetes, and heart disease.
Obesity is usually a result of inherited factors added to environmental and personal diet choices.
Even modest weight loss of one diagnosed as obese can improve their health issues associated with obesity. Diet changes, increased physical activity, along with behavior changes, can help a person lose weight. Weight loss procedures and prescription medications are optional for treating obesity.
In October of 2010, the FDA decided against approving BELVIQ based on the data provided. Their findings were based both on cancer-promoting properties of the drug, as well as the weight-loss efficacy of it being only ‘marginal.’
In May of 2012, Arena submitted a new round of studies to the FDA, which resulted in a vote to recommend the drug only under certain restrictions along with patient monitoring. One of the restrictions included patients who had a BMI of over 30, or with a BMI over 27 with a presence of two chronic diseases or conditions. In June of 2012, the FDA approved BELVIQ (Lorcaserin) to be used with adults who have a BMI of 30 or greater, or who are considered obese. It was also approved for adults with a BMI of 27 or higher and had at least one weight-related condition, such as type 2 diabetes, high cholesterol, or high blood pressure.
BMI, body mass index, is determined by an adult’s weight with respect to their height. If an adult is found to have a BMI of 25 to 29, they are considered overweight. If an adult has a BMI of 30 or more, they are considered obese. A BMI of 18.5 is deemed to be underweight, and normal weight is having a BMI of 18.5 to 24.9.
The effectiveness and safety of BELVIQ were evaluated by three random trials using a placebo. There were approximately 8,000 obese or overweight persons, some with type 2 diabetes and some without. These patients were treated anywhere from fifty-two to one-hundred-four weeks. The participants of the study conducted lifestyle modifications, including a reduced-calorie diet along with exercise counseling. The results showed those given the BELVIQ over those who received the placebo experienced a weight loss of 3 to 3.7 percent.
- What is a Placebo?
A placebo is a substance that is made to look like or resembles drugs but does not contain an active drug. These look-a-likes are generally filled with sugar or starch and are used in research studies such as clinical trials.
Even though there are no actual, active ingredients in a placebo, some people report they make them feel better; others develop side effects. These feelings are called the ‘placebo effect,’ and it is believed they occur for two reasons.
The first reason a person will report effects from placebo is ‘coincidental change. There are a lot of medical symptoms and conditions that come and go without treatment, so a person given a placebo may just coincidentally feel worse or better. When this happens during research or clinical trials, it can incorrectly affect the results of the study.
The second reason is anticipation or suggestibility. When a person anticipates how a drug will work, they believe it will and actually convince themselves it is working.
The placebo effect is mainly on just the symptoms and not the actual disease.
A little less than half of the participants without type 2 diabetes lost about 5 percent of their body weight, and only about 23 percent of the patients receiving the placebo lost this same amount of weight. Those with type 2 diabetes resulted in about 38 percent of them treated with BELVIQ, who lost nearly 5 percent of their body weight, and those treated with the placebo resulted in about 16 percent of them losing the same amount of weight.
The labeling on BELVIQ was approved only if it stated the drug be discontinued if a patient fails to lose 5 percent of their weight after taking the medication for twelve weeks. It was determined that these types of patients were unlikely to achieve meaningful weight loss with continued treatment.
The manufacturer of the drug was required to perform six postmarketing studies, and one of those studies was to be a long-term cardiovascular outcome trial. This trial was to assess the effect of BELVIQ on the risk for adverse cardiac events such as a stroke or heart attack. In July of 2016, the extended-release version of BELVIQ was given approval for use in the U.S.
Reported Side Effect from BELVIQ
In December of 2012, the United States Drug Enforcement Administration proposed classifying BELVIQ as a Schedule IV drug due to its hallucinogenic properties. These hallucinogens were experienced when patients took higher doses of the drug than they were prescribed. Users were also beginning to develop psychiatric dependencies on BELVIQ. In May of 2013, BELVIQ was classified as a Schedule IV drug by the United States Drug Enforcement Administration, under the Controlled Substances Act.
- Drug Enforcement Administration
The Drug Enforcement Administration is a federal law enforcement agency under the United States Justice Department. It is tasked with fighting drug distribution and trafficking in the United States. This agency is commonly referred to as the DEA. The Drug Enforcement Administration is the front agency for enforcing domestic enforcement of the Controlled Substances Act and shares jurisdiction with the Federal Bureau of Investigation, U.S. Customs and Border Protection, Homeland Security (DHS), and the Immigration and Customs Enforcement. The sole responsibility for the DEA is to pursue and coordinate U.S. drug investigations both abroad and domestic.
Concerns were circulating that BELVIQ (Lorcaserin) causes cardiac valvulopathy from the reports coming in that reported on the results of Phase 2 patient trials. Contradicting these reports, however, were the reports from a Phase 3 clinical trial of the drug. This study was published in an October 2014 Postgraduate Medicine journal. This is a peer-reviewed journal for doctors. The results, according to this study, found no significant differences in valvulopathy rates when compared to the control group. It was concluded that the drug was safe for the targeted population, although they did request more long-term data.
- Cardiac Valvulopathy
Cardiac Valviopathy, also known as cardiac fibrosis, is when an excess deposition of the extracellular matrix occurs in the cardiac muscle. The term can also refer to an abnormal thickening of the heart valves when an inappropriate proliferation occurs to the cardiac fibroblasts.
In January of 2020, a communication from the United States Food and Drug Administration stated there is a possible increase in the risk of cancer for those taking the drug BELVIQ (Lorcaserin). This communication comes after seeing the results from a clinical trial. The approval given by the FDA required the manufacturer of the drug to conduct randomized, placebo-controlled clinical trials to evaluate possible heart-related risks with the drug. The testing was done over five years and involved more than 12,000 participants. There were more diagnoses of cancer in the participants who were given BELVIQ than those who had been given the placebo within those five years.
In February of 2020, the Federal Drug Administration requested the manufacturer of BELVIQ (Lorcaserin) to withdraw the drug from markets in the United States voluntarily. This request comes from the clinical trial results showing an increased risk of cancer from this drug. Eisai, the manufacturer voluntarily withdrew the drug.
Five Facts About BELVIQ When Released in 2012
BELVIQ was the first diet drug released by the FDA in over thirteen years after their approval was given in June of 2012. It was said to offer an alternative aid in losing weight for one in three Americans who were considered obese. Arena Pharmaceuticals was producing this new diet alternative.
1. How BELVIQ Works
The drug BELVIQ was created to control a person’s appetite. It was to activate brain receptors for serotonin, a neurotransmitter that controls one’s feeling of satisfaction and satiety. Serotonin also controls your moods, and a lot of antidepressant medications work by preventing the reuptake of serotonin by keeping your brain receptors bathed in chemicals. Arena's research showed that their drug was designed to seek only the serotonin receptors, which affected one’s appetite.
2. How Effectively Did it Work?
The clinical trials submitted to the FDA by Arena showed almost half of the dieters who did not have Type 2 diabetes and used their drug had lost at least 5 percent of their starting weight, which amounted to approximately twelve pounds. This amount was lost over a year's time and compared against a group that took a placebo, with only 23 percent of that group losing weight over that year. The participants in the study were advised to combine the medication with a healthy diet and exercise program. The labeling of BELVIQ was to include a warning to people they should not take the drug for more than twelve weeks. It was to state that taking the medication longer than a twelve-week period would not result in significant weight loss.
3. Who Can Take BELVIQ?
The FDA's approval of BELVIQ was targeted for people who were diagnosed as obese. Those who should have taken BELVIQ were to have a BMI of 30 or higher or those who had a BMI of 27 or higher with at least one weight-related health condition such as high blood pressure, high cholesterol, or Type 2 diabetes.
4. Were There Any Side Effects Associated with BELVIQ?
The most common side effects associated with taking BELVIQ with its release in 2012 included:
- Dry mouth
- For patients with diabetes, side effects included low blood sugar, back pain, fatigue, and headaches
There was only mention and concern that BELVIQ had caused heart-valve defects in people and tumors in animal testing. There had been a previous weight-loss drug removed from the markets, which was also serotonin-based. The drug fenfluramine had been taken off markets in 1997 because it showed the same risk for heart damage.
The drug, BELVIQ, was given approval with the condition the company would monitor patients for heart-valve damage. It was required that the manufacturer would conduct six studies once the drug was allowed on the market to determine if it caused strokes or heart attacks in people.
5. Why did the FDA take so Long to Approve BELVIQ?
Diet pills have a history of safety problems. Meridia had to be taken off markets when it showed it was responsible for heart problems in patients, and when first introduced, BELVIQ and Qnexa were rejected over their safety concerns. When a person's body is manipulated by attempting to control its weight-controlling pathways, it can cause long-lasting consequences to the metabolic system and the heart. Drug developers have a high bar to clear when they try to prove their weight-loss drug solutions are safe.
January 2020, FDA Announces Risk of Cancer-Associated with BELVIQ
In January of 2020, the United States Food and Drug Administration (FDA) alerted the public that after the release of the data from a clinical trial assessing the safety of BELVIQ, it is now possible this drug increases the risk of cancer. The cause of the cancer is still undetermined, and it is not saying for a fact that BELVIQ is responsible, but there is evidence to 'suggest' it may be contributing to cancer risks. It is the FDA's goal with its announcement to make the public aware of the possible risk and to advise them they will continue investigating the drug's risks.
The announcement reported that health care professionals should consider the risks over the benefits of prescribing BELVIQ (Lorcaserin) when they decide to continue prescribing this drug to their patients. The announcement also included a warning to patients currently taking BELVIQ to speak with their doctor about the increased risk of cancer when taking this drug. They are advised to talk with their physician about the best decision concerning whether or not this medication should be continued as a medical treatment.
The FDA announced with their January 2020 statement they wanted to continue monitoring safety concerns with the drug BELVIQ and urged health care professionals as well as patients to report any side effects associated with taking the medication. In February 2020, they released a new statement concerning the risks associated with BELVIQ.
February 2020, FDA Makes New Statement Regarding Associated Risks with BELVIQ
One month after an announcement from the FDA that there was a 'possible' risk associated with taking the drug BELVIQ and cancer, it released a new statement that clinical studies are now proving the risk. The FDA requested in this announcement that the manufacturers of the drug BELVIQ (Lorcaserin) voluntarily withdraw this weight-loss drug from the United States markets. Eisai Inc. has freely withdrawn the drug.
The FDA stated they had taken this action as they believe the risks of lorcaserin far outweigh the benefits of this weight-loss drug. Their ruling is based on a completed review of results done through randomized clinical trials to assess the drug's safety.
Patients who have an unfinished dosage of this drug should talk to their doctor about an alternative weight-loss medicine or weight-loss program. The unused medication should be disposed of or taken to a drug take-back location. If you cannot get to one of the public disposal locations, you can dispose of at home by:
- Mixing the medication with an unappealing substance such as cat litter, used coffee grounds, or dirt. Do not crush the medicine before throwing it away.
- Put the unused portion of your prescription in a sealed plastic bag before throwing it into the garbage.
- Throw the container you’ve placed the medication into in your home garbage, not a public one.
- Remove your personal information from the prescription label before throwing or recycling them.
At this point, the FDA is not recommending any special screening for patients who have been taking the drug BELVIQ. You can talk to your doctor about any possible concerns or risks you may feel uncomfortable with after having taken this medication.
Health care professionals are now being told to stop dispensing or prescribing BELVIQ (Lorcaserin) to their patients. If you have patients currently taking this medication, it is advised you contact them directly and inform them of the increased risks of cancer that have been found in clinical trials. Doctors should advise patients to stop taking the medication and discuss alternative weight-loss drugs or programs.
What Did the FDA Find with Clinical Trials of BELVIQ?
When the FDA approved the drug BELVIQ (Lorcaserin), it requested the manufacturers to conduct randomized, double-blind, placebo-controlled clinical trials on it to evaluate risks. The clinical trials were looking for heart-related concerns, but results came back, showing an increased risk of cancer. Several different types of cancers were occurring more frequently in the group taking the drug BELVIQ than in the group given the placebo. The cancers that were found include; colorectal, lung, and pancreatic.
Reliable clinical studies performed on BELVIQ revealed those who took the drug lost only slightly more weight than the people who were given a placebo. In these particular trials, the participants were not given instructions in weight-loss protocols. In other tests where weight-loss protocols were given, those taking the drugs lost about twice as those who received the placebo. In almost all clinical trials, the weight loss was slight, and the participants regained weight after the tests.
Some of the side effects reported with those taking BELVIQ include:
- Heart valve damage
- Cognitive impairment, such as memory loss, difficulty focusing, and confusion
- Low white blood cell count or anemia
- Cancer was detected in lab rats in their breasts and brain
- Serotonin Syndrome
- Female breast milk reduction
- A decrease in heart rate
- Neuroleptic malignant syndrome
- High blood pressure in the lungs
- Psychiatric disorders such as depression, euphoria, and dissociation
- Growth of male breasts
- Allergic reactions
- Unusual thoughts or behaviors
- Pale skin
- Sores in the mouth or throat
- Flu symptoms
- Penis erection lasting longer than four hours
BELVIQ has been classified as Pregnancy Category X medication as there is evidence it causes fetal abnormalities. This information is based on adverse reaction data, and BELVIQ should only be used by pregnant women when and if the benefits can outweigh the possible risks.
If you or someone you know has taken the drug BELVIQ, and have experienced any of the life-altering side effects this drug is responsible for causing, you should contact Consumer Alert Now. We can help you discover if you are able to receive compensation for your injuries or suffering from this drug.
Where Can I Find a Mass Tort for BELVIQ Near Me?
If you, a friend, or a member of your family has taken the drug BELVIQ and is now suffering health-related diseases or injuries due to this drug, you need to contact Consumer Alert Now. Call us at 800-511-0747 and learn how you may be able to join a mass tort against the manufacturer of this dangerous drug. Drug companies have the responsibility to provide the public with safe products. When they allow consumers to take medications that can impact the quality of life, or cause life-threatening impact, they need to be held accountable. Consumer Alert Now can help you find the accountability you deserve for the harm BELVIQ has caused.