Belviq side effects go away

Belviq

Belviq is the brand name of the drug lorcaserin, which is used along with diet and exercise to treat obesity.

The medicine is sometimes given to treat obesity associated with high cholesterol, high blood pressure, or type 2 diabetes.

Belviq is in a class of drugs known as serotonin receptor agonists. It works by targeting chemicals in the brain that affect appetite.

The Food and Drug Administration (FDA) approved Belviq in 2012. The drug is manufactured by Arena Pharmaceuticals.

Belviq Warnings

This drug must be used along with a diet and exercise plan. Don’t stop taking Belviq without first talking to your doctor.

Before taking Belviq, you should tell your doctor if you have or have ever had:

  • Blood cell problems such as sickle cell anemia, multiple myeloma, or leukemia
  • A physical deformity of the penis, such as Peyronie’s disease
  • Diabetes
  • Heart failure
  • A slow or irregular heartbeat
  • Other heart problems
  • Liver disease
  • Kidney disease

You should tell your doctor you are taking Belviq before having any type of surgery, including a dental procedure.

You shouldn’t take any other prescription or over-the-counter (OTC) weight loss products while taking Belviq without first talking to your doctor.

Tell your physician about all medications you are taking before starting on Belviq, especially drugs to treat depression, migraines, mental problems, or the common cold. These medications may cause serious or life-threatening side effects when combined with Belviq.

Weight loss can cause low blood sugar in people who take certain medicines for type 2 diabetes.

If you have diabetes, check your blood sugar levels often while taking Belviq. Your doctor may need to change the doses of some of your medications if you develop low blood sugar.

Belviq may not be beneficial for you. If you don’t lose at least 5 percent of your starting weight during the first 12 weeks of treatment, your doctor might tell you to stop taking the medicine.

You should keep all appointments with your doctor and laboratory while taking Belviq. Your physician will probably order certain tests to check your body’s response to the drug.

The Belviq ‘High’ and Abuse

This medication can be habit-forming and could cause psychiatric dependency.

Large doses of Belviq may produce hallucinations or a “high” feeling. Never take more of the drug or take it more often than your doctor prescribes.

Belviq is a federally controlled substance because it can lead to abuse or drug dependence. In 2013, the Drug Enforcement Administration (DEA) classified Belviq as a Schedule IV drug under the Controlled Substances Act.

You should never share this medication with another person.

Pregnancy and Belviq

Belviq can harm an unborn baby. Tell your doctor right away if you are pregnant or plan on becoming pregnant while taking this medicine.

Weight loss during pregnancy can be harmful to a fetus, even if you are overweight.

It’s not known whether the drug passes into breast milk or if it could harm a breastfeeding baby.

You should not breastfeed while taking Belviq.

Weight-loss pill Belviq is now available, but we say skip it

Risks galore. What’s more, the drug can cause several side effects including, headache, dizziness, fatigue, nausea, dry mouth, and constipation. If you have diabetes, add hypoglycemia, back pain, and a cough to that list. The drug’s label also states that Belviq may cause a slowed heartbeat, heart valve problems, painful erections, and if you take more than is prescribed, hallucinations, euphoria, and slowed thinking. Those last risks promoted the Drug Enforcement Agency to classify the drug as a Schedule IV controlled substance, meaning that it poses a slight risk of dependence. Finally, Belviq may also interact adversely with other medications you take, such as drugs used to treat depression, migraines, or colds, and supplements, such as St. John’s wort and tryptophan.

The FDA’s advisory panel initially rejected Belviq because of a risk of tumors found in animal studies. And once approved last June, additional safety concerns delayed its release. Moreover, the European Medicines Agency was so concerned about the drug’s safety that it rejected the drug. The drug’s manufacturer, Arena Pharmaceuticals, recently withdrew its application for the drug’s use in Europe.

Diet Pills

Author: Chris Elkins, MA | Last Updated: 30-Jan-2020 | 29 sources

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How to Recognize Signs of Diet Pill Addiction

Individuals with behavioral addictions or drug addictions engage in compulsive behaviors despite negative consequences. If someone is physically dependent on a diet pill, they may take it to avoid withdrawal.

Diet pill abuse may be a symptom of an eating disorder. People may take the pills to avoid gaining weight, even if they have dangerously low weight or other health problems.

Warning signs of diet pill addiction include:

  • An eating disorder diagnosis
  • A history of substance use issues
  • Changes in appearance
  • Changes in behavior
  • Borrowing money frequently
  • Using diet pills without a prescription
  • Using diet pills in higher doses or more often that prescribed

Addiction is usually caused by underlying mental health issues, such as a history of trauma or abuse. Other mental illnesses, such as depression, anxiety and personality disorders, often co-occur alongside substance use disorders and eating disorders.

Individuals with an addiction to weight-loss pills should talk to their health provider about the best treatment option. In some cases, a primary care physician may be able to help them stop taking the drug. Inpatient or outpatient eating disorder clinics may also be able to help people address diet pill misuse. Drug rehab facilities may be most appropriate for individuals addicted to alcohol or other drugs in addition to diet pills.

AuthorChris Elkins, MA, Senior Content Writer, DrugRehab.com Chris Elkins worked as a journalist for three years and was published by multiple newspapers and online publications. Since 2015, he’s written about health-related topics, interviewed addiction experts and authored stories of recovery. Chris has a master’s degree in strategic communication and a graduate certificate in health communication. @ChrisTheCritic9

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FDA / AP

This photo provided by Food and Drug Administration shows Arena Pharmaceutical’s anti-obesity pill Belviq.

The first new prescription diet drug in 13 years won Food and Drug Administration (FDA) approval on Wednesday, offering a new alternative to aid weight loss for the nearly one in three Americans who are considered obese. The new drug, called Belviq (lorcaserin), is made by Arena Pharmaceuticals. Here’s what you need to know:

How does Belviq work?
The drug works by controlling appetite — specifically by activating brain receptors for serotonin, a neurotransmitter that triggers feelings of satiety and satisfaction. Serotonin is also involved in mood; many antidepressant drugs work by preventing the reuptake of serotonin and keeping brain receptors bathed in the chemical. Researchers at Arena say their drug is designed to seek out only the serotonin receptors that affect appetite.

How effective is it?
According to clinical trial data submitted by Arena to the FDA, nearly half of dieters without Type 2 diabetes who used the medication lost at least 5% of their starting weight — or an average of 12 lbs. — over a year, compared with 23% of those taking a placebo. For best results, dieters are advised to use the medication together with a healthy diet and exercise program. The approved labeling for Belviq also recommends that people discontinue the drug if they fail to lose 5% of their body weight after 12 weeks; longer treatment is unlikely to lead to meaningful weight loss.

(MORE: Calorie vs. Calorie: Study Evaluates Three Diets for Staying Slim)

Who can take Belviq?
The FDA approved the medication for people who are obese (with a body mass index, or BMI, of 30 or higher) or who are overweight (with a BMI of 27 or above) and also have at least one weight-related health condition such as Type 2 diabetes, high blood pressure or high cholesterol.

Are there any side effects?
The most common side effects of Belviq in non-diabetic patients are headache, dizziness, fatigue, nausea, dry mouth and constipation; in patients with diabetes, side effects include low blood sugar, headache, back pain, cough and fatigue.

There was also some concern that Belviq caused tumors in animals and heart-valve defects in people. A similar serotonin-based drug that had been approved for weight loss — fenfluramine — was removed from the market in 1997 because of the same heart concerns.

In 2010, the FDA rejected Arena’s first request for approval, asking for more evidence of its safety. New data provided by the company showed that heart problems would not occur at the low doses at which Belviq would be prescribed. The FDA won’t require patients taking Belviq to be monitored for heart-valve damage, but the company is required to conduct six studies once the drug reaches the market to determine whether it causes heart attacks or stroke in people who take it.

(MORE: A Brief History of Diet Pills and the FDA)

Why did it take so long to get a new weight-loss drug approved?
The history of diet pills has been plagued by safety problems. Since 1999, when the last prescription weight-loss medication, Xenical (orlistat), was given the green light, one weight loss drug, Meridia (sibutramine) was taken off the market when users began showing increased risk of heart problems, and two others, Belviq and Qnexa, were rejected by the FDA over safety concerns. Manipulating the body’s weight-controlling pathways can have long-term consequences on the heart and other metabolic systems, so drug developers have a high bar to clear to prove their compounds are safe.

Read the FDA’s announcement on Belviq here.

Alice Park is a writer at TIME. Find her on Twitter at @aliceparkny. You can also continue the discussion on TIME’s Facebook page and on Twitter at @TIME.

Crissi Estep had been on Cymbalta (duloxetine) a few years when the medication seemed to stop working. At first, it effectively controlled both her fibromyalgia-related nerve pain and her depression, but “any successes I had had with it earlier were gone,” Estep says.

“I was very depressed, even agitated, and felt like I had plateaued,” she added. When Estep shared her concerns with her physician, he added Abilify (aripripazole) to her medication regimen.

Estep soon developed intolerable side effects. Frustrated, she decided to quit taking her antidepressants.

Because she’s a registered nurse, Estep knew that antidepressant medications are usually tapered before they’re discontinued. So, she developed her own tapering schedule: 1 day between doses, then 2, until the medicine was gone.

Severe withdrawal symptoms hit about five days after the medication cleared her system. “I genuinely thought I was having a heart attack,” Estep says. “I had chest pains and was shaky and nauseous. When I turned my head, it would swish, like water in a bowl.”

The South Carolina resident was in Maine at the time, camping with her family, “literally googling ERs,” she says, when her husband wondered aloud if her symptoms might be related to the cessation of her medication. Together, they looked up withdrawal symptoms for her antidepressants. Estep was experiencing almost all of them.

Between 2011 and 2014, approximately 1 in 9 Americans reported taking at least one antidepressant medication in the past month. Sixty-eight percent of those people had been on their antidepressant for two years or longer; 25% had been taking anti-depressant medication for 10 years or more. At some point — typically, when they’re feeling better, but sometimes when they are frustrated by side effects — nearly every person who uses an antidepressant considers stopping the medication. But, as Estep learned, stopping antidepressant treatment without medical guidance is risky and can cause uncomfortable side effects, as well as a relapse of depression.

You should also know that the more depressive episodes you have had, the more time you should take to come off of the medication. Harvard Women’s Health Watch says that for those who have had 3 or more such episodes should wait for at least 2 years once symptoms ease to considering weaning off an antidepressant.

Regarding weaning off, it’s important not to taper off to quickly. Time is your friend and you should take things slowly. Coming off too quickly can increase the risk of nasty withdrawal symptoms, and increase the risk of a relapse. It’s not uncommon for some long-time antidepressant users to need a year or more to come off of medication.

The good news is there’s a right way to get off antidepressants.

Set Yourself Up for Success

The best time to go off an antidepressant is when your depression is in remission and life is stable. “Big life transitions, such as a job change, graduating from college, getting married or having a baby, are not a good time,” says Carl Olden, MD, a family physician in Yakima, WA, and a member of the board of directors of the American Academy of Family Physicians.

It’s also a good idea to bolster your support system and boost self-care strategies. “You’ll have the best chances of success if you have a team around you,” says Jane Payne, MD, a psychiatrist in private practice in Portland, OR. Ideally, your team will include the medical professional who prescribes your medication and at least one or two close friends or family members who know about your history of depression.

“Be as forthright as you can with them about what depression was like for you, about how your behavior changed, and let them know you’re going off your medication, so they can be on the lookout for red flags,” Dr. Payne says. Also share with them some successful coping strategies you’ve used in the past (such as journaling, exercise or time in nature), and ask them to encourage and support your self-care efforts as you transition off medication.

With your health care provider, develop a plan. Your provider will want to know how you fare on days or weekends when you forget to take your antidepressant. That information will help your provider plan an appropriate quitting schedule. And if your antidepressant serves multiple purposes – say, managing nerve pain and depression – your provider may need to prescribe another medication to keep your health under control.

Don’t let your antidepressant prescription lapse. Make sure you have some left, “in case you need to start back up,” Dr. Olden says.

Go Slow

“Any medication that you’ve been on for more than a couple of weeks that works on the central nervous system has initiated changes within the brain to adapt to the presence of that medication,” Dr. Payne says. “If you suddenly take the medication away, the changes are still present without anything to balance them.”

Gradually tapering – decreasing the dose – of the medication over a period of time allows your body to readjust. That’s why clinicians recommend weaning antidepressant medication over a period of weeks — and often for far longer than that.

The length of the weaning period will vary depending on the antidepressant, dosage, duration of treatment and individual response. It may take as little as 5 days, or a month or more to wean completely off an antidepressant.

Follow the weaning schedule recommended by your healthcare provider, and don’t hesitate to report adverse effects.

“If you’re having withdrawal symptoms, find yourself unable to sleep or your mood is really up and down, it might be that you’re coming off too fast,” Dr. Payne says. A more gradual approach could eliminate your symptoms.

Know What to Expect

Some people experience a transient increase in depression-related symptoms, such as difficulty sleeping, anxiety and agitation, while coming off their medication. Other adverse symptoms may include constipation, diarrhea, dizziness and nausea.

In most cases, these symptoms will subside within a few weeks. “This is why it really helps to be in contact with a doctor who has a sense of your baseline, who can tell the difference between a rough patch and things going south,” Dr. Payne says. When in doubt, call your physician, who can help you determine if you need medical treatment.

If your depressive symptoms re-emerge after you’ve stopped the antidepressant, you may need to restart the medication – and that’s OK. “There are some folks who are better served by staying on antidepressants,” Dr. Olden says.

Estep restarted her antidepressant while still on vacation. After she returned home, she spoke to her doctor and “did a very slow wean” that was “pretty uneventful,” she says. One month later, she was off her antidepressant.

Action Points

Treat weight problems first, then deal with comorbidities like dyslipidemia, hypertension, and impaired glucose tolerance, a new guideline urges.

It’s an entirely new approach to the treatment of disease, said Caroline Apovian, MD, of Boston University, the lead author of a new guideline for treating obesity with medications, published online in the Journal of Clinical Endocrinology and Metabolism.

“The old paradigm was to treat each comorbidity with medications … then manage obesity, which caused most of the original problems in the first place,” Apovian said during a press briefing. “The new paradigm is to manage the obesity first, with lifestyle change and medications, then manage the remainder of the comorbidities that have not responded.”

The guideline focuses on medical management of obesity, a component left out of earlier guidelines released by the American Heart Association, the American College of Cardiology, and the Obesity Society, since they were written before many of the new weight-loss drugs were approved.

Those drugs, coupled with extensive lifestyle counseling and clinician visits, are poised to help patients who’ve struggled to lose weight for years by enhancing their ability to make behavioral change, Apovian said.

That, in turn, should diminish their need for medications to manage other conditions that are tied to obesity, including diabetes, hypertension, and dyslipidemia, she said.

Several obesity experts contacted by MedPage Today said they agreed with the new guidance, that treating overweight and obesity could resolve many of the conditions that commonly occur with it.

“Treating obesity is good,” said Joel Zonszein, MD, of Albert Einstein College of Medicine in New York. “It is at the core of the hypertension, dyslipidemia, insulin resistance, and diabetes that we see.”

Four new obesity drugs have been approved in the last few years: Belviq, Qsymia, Contrave, and Saxenda. Many of these medications work by amplifying the effects of behavioral changes, Apovian said, and they have the greatest effect when they’re reinforced with face-to-face visits — the literature says at least 16 visits per year, a figure that federal insurers reimburse for.

“Adding the medications to a diet and lifestyle program leads to a greater enhancement of their effects,” she said. “And we recommend that if you’re going to treat weight management patients that you see them frequently.”

Apovian noted that the Endocrine Society still stands by the AHA/ACC/TOS guidelines on weight management, and that the current guidelines simply fill a gap that wasn’t addressed in the 2013 guidance.

The new guidelines are the first to mention specific obesity drugs and give some guidance on how to prescribe them.

In patients with uncontrolled hypertension or a history of heart disease, the guidelines recommend against using the sympathomimetic agents phentermine (a component of Qsymia) and diethylpropion.

Patients with cardiovascular risk, for instance, should be put on the drugs with the lowest cardiovascular risk, which include orlistat (Alli, Xenical) or lorcaserin (Belviq), Apovian said.

Patients should be put on the drugs for a 3-month trial period, starting at the lowest dose and titrating up, the guidelines state. If they don’t lose at least 5% of their body weight in that time, they should be switched to another drug.

“You have to give your best guess as to which drug the patient should go on based on their lifestyle characteristics that make them amenable to that particular drug,” Apovian said. “Unless you have a very clear idea of what drug you think the patient will do best on, it’s going to be trial and error.”

The guidelines also offer specifics on dietary recommendations — taking down saturated fats and trans fats for those with lipid problems, lowering salt and going on the DASH diet if they have hypertension — and calling for 150 minutes per week of moderate-intensity exercise.

They also cover how to treat patients who have both obesity and diabetes, urging clinicians to wean patients off diabetes drugs that make them gain weight, such as insulin, sulfonylureas, and thiazolidinediones, and replacing them with drug classes that promote weight loss, including GLP-1 agonists and SGLT2 inhibitors.

The question remains whether insurance will cover these medications, Zonszein said.

“Many insurances do not want to pay for obesity drugs,” he told MedPage Today. “And they’re expensive. They can cost between $4,000 and $6,000 per year.”

Included as part of the PRECAUTIONS section.

Serotonin Syndrome Or Neuroleptic Malignant Syndrome (NMS)-like Reactions

BELVIQ is a serotonergic drug. The development of a potentially life-threatening serotonin syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions have been reported during use of serotonergic drugs, including, but not limited to, selective serotonin-norepinephrine reuptake inhibitors (SNRIs) and selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants (TCAs), bupropion, triptans, dietary supplements such as St. John’s Wort and tryptophan, drugs that impair metabolism of serotonin (including monoamine oxidase inhibitors ), dextromethorphan, lithium, tramadol, antipsychotics or other dopamine antagonists, particularly when used in combination .

Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Serotonin syndrome, in its most severe form, can resemble neuroleptic malignant syndrome, which includes hyperthermia, muscle rigidity, autonomic instability with possible rapid fluctuation of vital signs, and mental status changes. Patients should be monitored for the emergence of serotonin syndrome or NMS-like signs and symptoms.

The safety of BELVIQ when coadministered with other serotonergic or antidopaminergic agents, including antipsychotics, or drugs that impair metabolism of serotonin, including MAOIs, has not been systematically evaluated and has not been established.

If concomitant administration of BELVIQ with an agent that affects the serotonergic neurotransmitter system is clinically warranted, extreme caution and careful observation of the patient is advised, particularly during treatment initiation and dose increases. Treatment with BELVIQ and any concomitant serotonergic or antidopaminergic agents, including antipsychotics, should be discontinued immediately if the above events occur and supportive symptomatic treatment should be initiated .

Regurgitant cardiac valvular disease, primarily affecting the mitral and/or aortic valves, has been reported in patients who took serotonergic drugs with 5-HT2B receptor agonist activity. The etiology of the regurgitant valvular disease is thought to be activation of 5-HT2B receptors on cardiac interstitial cells. At therapeutic concentrations, BELVIQ is selective for 5-HT2C receptors as compared to 5- HT2B receptors. In clinical trials of 1-year duration, 2.4% of patients receiving BELVIQ and 2.0% of patients receiving placebo developed echocardiographic criteria for valvular regurgitation at one year (mild or greater aortic regurgitation and/or moderate or greater mitral regurgitation): none of these patients was symptomatic .

BELVIQ has not been studied in patients with congestive heart failure or hemodynamically-significant valvular heart disease. Preliminary data suggest that 5HT2B receptors may be overexpressed in congestive heart failure, Therefore, BELVIQ should be used with caution in patients with congestive heart failure.

BELVIQ should not be used in combination with serotonergic and dopaminergic drugs that are potent 5- HT2B receptor agonists and are known to increase the risk for cardiac valvulopathy (e.g., cabergoline).

Patients who develop signs or symptoms of valvular heart disease, including dyspnea, dependent edema, congestive heart failure, or a new cardiac murmur while being treated with BELVIQ should be evaluated and discontinuation of BELVIQ should be considered.

In clinical trials of at least one year in duration, impairments in attention and memory were reported adverse reactions associated with 1.9% of patients treated with BELVIQ and 0.5% of patients treated with placebo, and led to discontinuation in 0.3% and 0.1% of these patients, respectively. Other reported adverse reactions associated with BELVIQ in clinical trials included confusion, somnolence, and fatigue .

Since BELVIQ has the potential to impair cognitive function, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that BELVIQ therapy does not affect them adversely .

Events of euphoria, hallucination, and dissociation were seen with BELVIQ at supratherapeutic doses in short-term studies . In clinical trials of at least 1-year in duration, 6 patients (0.2%) treated with BELVIQ developed euphoria, as compared with 1 patient ( < 0.1%) treated with placebo. Doses of BELVIQ should not exceed 10 mg twice a day.

Some drugs that target the central nervous system have been associated with depression or suicidal ideation. Patients treated with BELVIQ should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Discontinue BELVIQ in patients who experience suicidal thoughts or behaviors .

Potential Risk Of Hypoglycemia In Patients With Type 2 Diabetes Mellitus On Anti-diabetic Therapy

Weight loss may increase the risk of hypoglycemia in patients with type 2 diabetes mellitus treated with insulin and/or insulin secretagogues (e.g., sulfonylureas); hypoglycemia was observed in clinical trials with BELVIQ. BELVIQ has not been studied in combination with insulin. Measurement of blood glucose levels prior to starting BELVIQ and during BELVIQ treatment is recommended in patients with type 2 diabetes. Decreases in medication doses for anti-diabetic medications which are non-glucosedependent should be considered to mitigate the risk of hypoglycemia. If a patient develops hypoglycemia after starting BELVIQ, appropriate changes should be made to the anti-diabetic drug regimen .

Priapism (painful erections greater than 6 hours in duration) is a potential effect of 5-HT2C receptor agonism.

If not treated promptly, priapism can result in irreversible damage to the erectile tissue. Men who have an erection lasting greater than 4 hours, whether painful or not, should immediately discontinue the drug and seek emergency medical attention.

BELVIQ should be used with caution in men who have conditions that might predispose them to priapism (e.g., sickle cell anemia, multiple myeloma, or leukemia), or in men with anatomical deformation of the penis (e.g., angulation, cavernosal fibrosis, or Peyronie’s disease). There is limited experience with the combination of BELVIQ and medication indicated for erectile dysfunction (e.g., phosphodiesterase type 5 inhibitors). Therefore, the combination of BELVIQ and these medications should be used with caution.

In clinical trials of at least 1-year in duration, the mean change in heart rate (HR) was -1.2 beats per minute (bpm) in BELVIQ and -0.4 bpm in placebo-treated patients without diabetes and -2.0 beats per minute (bpm) in BELVIQ and -0.4 bpm in placebo-treated patients with type 2 diabetes. The incidence of HR less than 50 bpm was 5.3% in BELVIQ and 3.2% in placebo-treated patients without diabetes and 3.6% in BELVIQ and 2.0% in placebo-treated patients with type 2 diabetes. In the combined population, adverse reactions of bradycardia occurred in 0.3% of BELVIQ and 0.1% of placebo-treated patients. Use with caution in patients with bradycardia or a history of heart block greater than first degree.

In clinical trials of at least one year in duration, adverse reactions of decreases in white blood cell count (including leukopenia, lymphopenia, neutropenia, and decreased white cell count) were reported in 0.4% of patients treated with BELVIQ as compared to 0.2% of patients treated with placebo. Adverse reactions of decreases in red blood cell count (including anemia and decreases in hemoglobin and hematocrit) were reported by 1.3% of patients treated with BELVIQ as compared to 1.2% treated with placebo . Consider periodic monitoring of complete blood count during treatment with BELVIQ.

Lorcaserin moderately elevates prolactin levels. In a subset of placebo-controlled clinical trials of at least one year in duration, elevations of prolactin greater than the upper limit of normal, two times the upper limit of normal, and five times the upper limit of normal, measured both before and 2 hours after dosing, occurred in 6.7%, 1.7%, and 0.1% of BELVIQ-treated patients and 4.8%, 0.8%, and 0.0% of placebo-treated patients, respectively . Prolactin should be measured when symptoms and signs of prolactin excess are suspected (e.g., galactorrhea, gynecomastia). There was one patient treated with BELVIQ who developed a prolactinoma during the trial. The relationship of BELVIQ to the prolactinoma in this patient is unknown.

Certain centrally-acting weight loss agents that act on the serotonin system have been associated with pulmonary hypertension, a rare but lethal disease. Because of the low incidence of this disease, the clinical trial experience with BELVIQ is inadequate to determine if BELVIQ increases the risk for pulmonary hypertension.

See FDA-approved patient labeling (PATIENT INFORMATION).

  • BELVIQ is indicated for chronic weight management only in conjunction with a reduced-calorie diet and increased physical activity.
  • Patients should be instructed to discontinue use of BELVIQ if they have not achieved 5% weight loss by 12 weeks of treatment.
  • Patients should be informed of the possibility of serotonin syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions with the combined use of BELVIQ with other serotonergic drugs, including selective serotonin-norepinephrine reuptake inhibitors (SNRIs) and selective serotonin reuptake inhibitors (SSRIs), triptans, drugs that impair metabolism of serotonin (including monoamine oxidase inhibitors ), dietary supplements such as St. John’s Wort and tryptophan, tramadol, or antipsychotics or other dopamine antagonists.
  • Patients who develop signs or symptoms of valvular heart disease, including dyspnea or dependent edema should seek medical attention.
  • Patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that BELVIQ therapy does not affect them adversely.
  • Patients should be instructed to seek medical attention in the event of emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.
  • Patients should be cautioned not to increase their dose of BELVIQ.
  • Men who have an erection lasting greater than 4 hours, whether painful or not, should immediately discontinue the drug and seek emergency medical attention.
  • Patients should be instructed to avoid pregnancy or breastfeeding while undergoing BELVIQ therapy and to talk to their prescribing physician should they get pregnant or decide to breastfeed.
  • Patients should tell their healthcare provider about all the medications, nutritional supplements and vitamins (including any weight loss products) that they may take while taking BELVIQ.

Lorcaserin hydrochloride was not mutagenic in an in vitro bacterial mutation assay (Ames test), was not clastogenic in an in vitro chromosome aberration assay in Chinese hamster ovary cells, and was not genotoxic in an in vivo micronucleus assay in rat bone marrow.

The carcinogenic potential of lorcaserin hydrochloride was assessed in two-year carcinogenicity studies in mice and rats. CD-1 mice received doses of 5, 25 and 50 mg/kg. There were no treatmentrelated increases in the incidence of any tumor in mice at doses that produced plasma exposure in males and females of 8 and 4-times the daily human clinical dose, respectively.

In the rat carcinogenicity study, male and female Sprague-Dawley rats received 10, 30, and 100 mg/kg lorcaserin hydrochloride. In females, mammary adenocarcinoma increased at 100 mg/kg, which was associated with plasma exposures that were 87-times the daily human clinical dose. The incidence of mammary fibroadenoma was increased in female rats at all doses with no safety margin to the clinical dose. The increases in adenocarcinomas and fibroadenomas may be associated with lorcaserin hydrochloride-induced changes in prolactin homeostasis in rats. The relevance of the increased incidence of mammary adenocarcinomas and fibroadenomas in rats to humans is unknown.

In male rats, treatment-related neoplastic changes were observed in the subcutis (fibroadenoma, Schwannoma), the skin (squamous cell carcinoma), mammary gland (adenocarcinoma and fibroadenoma), and the brain (astrocytoma) at greater than or equal to 30 mg/kg (plasma exposure 17-times human clinical dose). At higher exposure, liver adenoma and thyroid follicular cell adenoma were increased but were considered secondary to liver enzyme induction in rats and are not considered relevant to humans. Human brain exposure (AUC24h,ss) to lorcaserin at the clinical dose is estimated to be 70-fold lower than brain exposure in rats at the dose at which no increased incidence of astrocytoma was observed. Excluding the liver and thyroid tumors, these neoplastic findings in male rats are of unknown relevance to humans.

Potential effects on fertility were assessed in Sprague-Dawley rats in which males were dosed with lorcaserin hydrochloride for 4 weeks prior to and through the mating period, and females were dosed for 2 weeks prior to mating and through gestation day 7. Lorcaserin hydrochloride had no effects on fertility in rats at exposures up to 29 times the human clinical dose.

Pregnancy Category X.

BELVIQ is contraindicated during pregnancy, because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm. Maternal exposure to lorcaserin in late pregnancy in rats resulted in lower body weight in offspring which persisted to adulthood. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard of maternal weight loss to the fetus.

A minimum weight gain, and no weight loss, is currently recommended for all pregnant women, including those who are already overweight or obese, due to the obligatory weight gain that occurs in maternal tissues during pregnancy.

Animal Data

Reproduction studies were performed in pregnant rats and rabbits that were administered lorcaserin during the period of embryofetal organogenesis. Plasma exposures up to 44 and 19 times human exposure in rats and rabbits, respectively, did not reveal evidence of teratogenicity or embryolethality with lorcaserin hydrochloride.

In a pre- and postnatal development study, maternal rats were dosed from gestation through post-natal day 21 at 5, 15, and 50mg/kg lorcaserin; pups were indirectly exposed in utero and throughout lactation. The highest dose (~44 times human exposure) resulted in stillborns and lower pup viability. All doses lowered pup body weight similarly at birth which persisted to adulthood; however, no developmental abnormalities were observed and reproductive performance was not affected at any dose.

Nursing Mothers

It is not known whether BELVIQ is excreted in human milk. Because many drugs are excreted in human milk, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

The safety and effectiveness of BELVIQ in pediatric patients below the age of 18 have not been established and the use of BELVIQ is not recommended in pediatric patients.

In the BELVIQ clinical trials, a total of 135 (2.5%) of the patients were 65 years of age and older.

Clinical studies of BELVIQ did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects, but greater sensitivity of some older individuals cannot be ruled out.

Since elderly patients have a higher incidence of renal impairment, use of BELVIQ in the elderly should be made on the basis of renal function . Elderly patients with normal renal function should require no dose adjustment.

No dose adjustment of BELVIQ is required in patients with mild renal impairment. Use BELVIQ with caution in patients with moderate renal impairment. Use of BELVIQ in patients with severe renal impairment or end stage renal disease is not recommended .

Dose adjustment is not required for patients with mild hepatic impairment (Child-Pugh score 5-6) to moderate hepatic impairment (Child-Pugh score 7-9). The effect of severe hepatic impairment on lorcaserin was not evaluated. Use lorcaserin with caution in patients with severe hepatic impairment .

Having a hard time losing weight? Your brain may play a role.

Your brain has many jobs. One is to ensure that you never go hungry. Unfortunately, when we diet and reduce what we eat, the body may believe we are starving. It then sends signals to the brain to eat more.
Lorcaserin, the active ingredient in BELVIQ/BELVIQ XR helps you feel full by targeting a hunger receptor in the brain. The precise way BELVIQ/BELVIQ XR produces feelings of satisfaction is not fully understood. By adding BELVIQ/BELVIQ XR to your weight-loss routine, you may be able to eat less and still feel satisfied.

How BELVIQ/BELVIQ XR works

It all starts with chemical messengers called neurotransmitters. Some neurotransmitters, like dopamine, can stimulate the brain, telling us to take a certain action such as “Eat now!”
Other neurotransmitters, like serotonin, can make you feel full. Basically, when we smell food, some neurotransmitters are released that make us want to eat. When we eat, serotonin is released, making us feel full.
Just as serotonin naturally turns on receptors to cause feelings of fullness, BELVIQ/BELVIQ XR is believed to selectively turn on these “fullness receptors,” helping you feel full while eating less food.
BELVIQ/BELVIQ XR is not a stimulant or narcotic. It is a federally controlled substance with some risk of abuse or dependency.

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When you start to think about medication for weight loss, you and your healthcare provider should be asking: Does it work? Is it safe? And for how long can I take it?

Turns out, a long-term, robust study published late last year answered these questions about Belviq for you. Belviq is expensive and there’s no generic yet. But, is it worth a closer look, and how does it compare to other weight loss medications?

How does Belviq cause weight loss?

Belviq is known as a selective serotonin 2C receptor agonist, which means it activates very specific parts of your brain that make you feel full. Less hunger leads to less eating, which leads to weight loss.

Is Belviq safe for the heart?

Yes, it appears so. A recent clinical trial involving 12,000 folks with obesity and high blood pressure, diabetes, or high cholesterol (known risk factors for heart disease) were given 10 mg of Belviq twice a day for over 3 years. Belviq reduced patients’ weight and did not increase the risk of cardiovascular complications.

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How well does Belviq work?

Belviq vs. Orlistat

Belviq and Orlistat result in the same amount of weight loss: 3 – 4 kg on average or almost 9 lbs. But Belviq has a leg up on side effects. Orlistat reduces how much fat you absorb from the food you consume, which results in frequent loose stools and gas. This isn’t the case with Belviq. Orlistat may also lower your vitamin D and B levels, and its weight loss effects tend to plateau at 3 – 4 months of use.

Belviq vs. Qsymia

Qsymia causes slightly more weight loss than Belviq. So, why not just choose Qsymia? Qsymia comes with prescribing restrictions because it may cause birth defects. If you are thinking about becoming pregnant, you should not use it. Qsymia may also cause your heart rate to speed up, and at higher doses, may result in depression and anxiety.

Belviq vs. Contrave

Contrave results in the same amount of weight loss as Belviq, but has more side effects, including nausea, headache, and dizziness. Contrave also does not have the long-term heart safety data that Belviq has.

Belviq vs. phentermine

While Belviq and phentermine haven’t been compared head to head, phentermine is FDA-approved for short-term use, works well, and has been around forever. It’s also available as a cheap generic. But be aware: It may cause some dry mouth at doses of 37.5 mg daily.

Does Belviq have other benefits?

Yes. Here is an area where Belviq shines. In addition to causing weight loss, Belviq can lower blood sugar levels and possibly, blood pressure and LDL (“bad”) cholesterol levels. By lowering blood sugar levels, Belviq reduces the risk of diabetes among prediabetic patients, and for people with diabetes, it helps lower Hb-A1c levels.

What are the common side effects of Belviq?

People taking Belviq generally tolerate the medication well, but mild side effects may include headache, upper respiratory infections, dizziness, and nausea.

Who should not take Belviq?

Folks who are taking SSRI antidepressants (selective serotonin reuptake inhibitors) like sertraline (Zoloft), atypical antidepressants like bupropion (Wellbutrin), or tricyclic antidepressants like amitriptyline (Amitril) and nortriptyline (Pamelor) should not take Belviq. Mixing these medications can cause a serious reaction known as serotonin syndrome, which can consist of tremors, sweating, fever, diarrhea, seizures, and muscle deterioration.

What has your experience been?

Dr O.

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