In 2012, the FDA approved a new drug for weight loss – Belviq. This drug is used as an obesity therapy in adult patients, whose BMI is:
- 30 kg / m2 or more
- 27 kg / m2 and above, in case of risk factors such as type 2 diabetes, hypertension, dyslipidemia)
Any drug can cause side effects and Belviq is not an exception. All Belviq side effects are dose-dependent and often caused by individual features of the patient.
As indicated in most Belviq side effects reviews, usually patients can experience Belviq adverse reactions, such as:
- Dry mouth
Often, Belviq side effects appear under the influence of active substance Lorcaserin Hydrochloride. Its effect is based on the fact that it blocks the urges of hunger and keeps a feeling of fullness for a long time.
As indicated in Belviq patient reviews of 2014/2015, the side effects of Belviq tend to appear at the beginning of obesity treatment and go away as soon as the body of obese person adapts to the influence of anorexigenic substance – Lorcaserin.
However, sometimes, some patients can experience really severe Belviq side effects when using this diet drug. As noted in Prescribing Information, Belviq appetite suppressant can cause Serotonin Syndrome or Neuroleptic Malignant Syndrome.
Such conditions may occur when using medications that inhibit serotonin reuptake or most often in combination of Belviq anorectic drug with certain medications for depression, migraine headaches, common cold.
The patient should immediately consult a doctor if he is experiencing one of the following Belviq side effects:
- Chills and fever
- High or low blood pressure
- Increased sweating
- Muscle convulsions and loss of coordination
- Change in mental status (hallucinations, agitation, confusion)
This weight loss drug can cause valvular heart disease in some patients and herewith the patient can experience Belviq side effects, such as:
- irregular heartbeat
- swelling of the extremities
- shortness of breath
- fatigue or weakness that will not go away
The appearance of some side effects may depend on the patient’s gender. For example, Belviq side effects on men include painful erection (priapism), which can last more than 6 hours. In such a case, you should stop taking the slimming drug and seek medical advice.
It often happens that under the influence of Belviq, the level of hormone prolactin may increase in the patient’s body. Herewith, the patient feels pain in the mammary glands. Breasts begin to produce milk, regardless of the patient’s gender. This Belviq side effect goes away together with the termination of using Belviq diet medicine.
If the patient noticed that his breast increases or milky liquid is released from the breast, he should stop using Belviq and seek medical advice.
As noted in Belviq patient reviews, the patients, who suffer from the diseases of the gastrointestinal tract, may experience Belviq side effects such as heartburn and diarrhea. How long these adverse reactions last depends on the taken dose and the drugs taken simultaneously with Belviq.
Patients should pay attention to the fact that the level of blood sugar depends on the drug interaction of Belviq anorectic with drugs taken for the treatment of type 2 diabetes. Belviq drug for weight correction can cause hypoglycemia.
So, before to start the obesity therapy with Belviq, as well as during the whole therapy, the patient should periodically check his blood sugar. Among other Belviq side effects, depression or thoughts of suicide were noted.
The doctor should pay attention to the person’s mental state taking Belviq weight management product. Any changes in the patient’s psyche, such as mood swings, sudden thoughts and talks about death may indicate serious Belviq side effect.
If the patient has mental changes, he should immediately consult the doctor or psychotherapist.
Lorcaserin is used with a doctor-approved exercise, behavior change, and reduced-calorie diet program to help you lose weight. It is used by certain overweight people, such as those who are obese or have weight-related medical problems. Losing weightand keeping it off can lessen the many health risks that come with obesity, including heart disease, diabetes, high blood pressure, and a shorter life. Lorcaserin belongs to a class of drugs known as serotonin receptor agonists. It is thought to work by affecting a certain part of the brain that helps control your appetite. Read the Patient Information Leaflet if available from your pharmacist before you start taking lorcaserin and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth with or without food as directed by your doctor, usually 2 times each day. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.
Lorcaserin may be habit forming. Do not increase your dose or take this drug more often than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.
If you do not lose a certain amount of weight within the first 12 weeks of treatment, you may not benefit from taking this medication and your doctor may direct you to stop taking it. Talk to your doctor for details.
Nausea, dry mouth, headache, dizziness, constipation, or tiredness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: easy bleeding/bruising, enlarged breasts or abnormal breast milk production, mental/mood changes (such as confusion, depression, thoughts of suicide, unusual agitation, difficulty with attention/memory), shaking/twitching muscles, shortness of breath, slow/fast/irregular heartbeat, swelling ankles/feet/hands, unexplained fever.
If you are taking medication to treat diabetes, lorcaserin can increase your risk for low blood sugar (hypoglycemia). Symptoms of low blood sugar include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. Tell your doctor right away about the reaction and the use of this product. Your doctor may need to adjust your medication(s). Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
See also Side Effects section.
Before taking lorcaserin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This drug may make you dizzy or slow your thinking. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
If you have diabetes, this product may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of low blood sugar (see Side Effects section). Your doctor may need to adjust your diabetes medication, exercise program, or diet.
This medication must not be used during pregnancy. It may harm an unborn baby. Discuss the use of reliable forms of birth control with your doctor. If you become pregnant or think you may be pregnant, tell your doctor right away.
It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval. A product that may interact with this drug is: cabergoline.
This medication can slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include dextromethorphan, among others.
If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: hallucinations, feeling “high,” feelings of standing next to yourself (disassociation).
Do not share this medication with others. It is against the law and may cause harm. Keep this medicine in a safe place to prevent theft, misuse, or abuse.
Laboratory and/or medical tests (such as complete blood count, prolactin levels) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip themissed dose and resume your usual dosing schedule. Do not double the dose to catch up.
Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.
Clinical Trials Experience
In the BELVIQ placebo-controlled clinical database of trials of at least one year in duration, of 6888 patients (3451 BELVIQ vs. 3437 placebo; age range 18-66 years, 79.3% women, 66.6% Caucasians, 19.2% Blacks, 11.8% Hispanics, 2.4% other, 7.4% type 2 diabetics), a total of 1969 patients were exposed to BELVIQ 10 mg twice daily for 1 year and 426 patients were exposed for 2 years.
In clinical trials of at least one year in duration, 8.6% of patients treated with BELVIQ prematurely discontinued treatment due to adverse reactions, compared with 6.7% of placebo-treated patients. The most common adverse reactions leading to discontinuation more often among BELVIQ treated patients than placebo were headache (1.3% vs. 0.8%), depression (0.9% vs. 0.5%) and dizziness (0.7% vs. 0.2%).
Most Common Adverse Reactions
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The most common adverse reactions for non-diabetic patients (greater than 5% and more commonly than placebo) treated with BELVIQ compared to placebo were headache, dizziness, fatigue, nausea, dry mouth, and constipation. The most common adverse reactions for diabetic patients were hypoglycemia, headache, back pain, cough, and fatigue. Adverse reactions that were reported by greater than or equal to 2% of patients and were more frequently reported by patients taking BELVIQ compared to placebo are summarized in Table 2 (non-diabetic subjects) and Table 3 (subjects with type 2 diabetes mellitus).
Serotonin-associated Adverse Reactions
SSRIs, SNRIs, bupropion, tricyclic antidepressants, and MAOIs were excluded from the BELVIQ trials. Triptans and dextromethorphan were permitted: 2% and 15%, respectively, of patients without diabetes and 1% and 12%, respectively, of patients with type 2 diabetes experienced concomitant use at some point during the trials. Two patients treated with BELVIQ in the clinical program experienced a constellation of symptoms and signs consistent with serotonergic excess, including one patient on concomitant dextromethorphan who reported an event of serotonin syndrome. Some symptoms of possible serotonergic etiology that are included in the criteria for serotonin syndrome were reported by patients treated with BELVIQ and placebo during clinical trials of at least 1 year in duration. In both groups, chills were the most frequent of these events (1.0% vs. 0.2%, respectively), followed by tremor (0.3% vs. 0.2%), confusional state (0.2% vs. less than 0.1%), disorientation (0.1% vs. 0.1%) and hyperhidrosis (0.1% vs. 0.2%). Because serotonin syndrome has a very low incidence, an association between BELVIQ and serotonin syndrome cannot be excluded on the basis of clinical trial results.
Hypoglycemia in Patients with Type 2 Diabetes
In a clinical trial of patients with type 2 diabetes mellitus, hypoglycemia requiring the assistance of another person occurred in 4 (1.6%) of BELVIQ-treated patients and in 1 (0.4%) placebo-treated patient. Of these 4 BELVIQ-treated patients, all were concomitantly using a sulfonylurea (with or without metformin). BELVIQ has not been studied in patients taking insulin. Hypoglycemia defined as blood sugar less than or equal to 65 mg/dL and with symptoms occurred in 19 (7.4%) BELVIQ-treated patients and 16 (6.3%) placebo-treated patients.
In clinical trials of at least 1-year duration, adverse reactions related to cognitive impairment (e.g., difficulty with concentration/attention, difficulty with memory, and confusion) occurred in 2.3% of patients taking BELVIQ and 0.7% of patients taking placebo.
Psychiatric disorders leading to hospitalization or drug withdrawal occurred more frequently in patients treated with BELVIQ (2.2%) as compared to placebo (1.1%) in non-diabetic patients.
Euphoria. In short-term studies with healthy individuals, the incidence of euphoric mood following supratherapeutic doses of BELVIQ (40 and 60 mg) was increased as compared to placebo [see Drug Abuse and Dependence. In clinical trials of at least 1-year duration in obese patients, euphoria was observed in 0.17% of patients taking BELVIQ and 0.03% taking placebo.
Depression and Suicidality. In trials of at least one year in duration, reports of depression/mood problems occurred in 2.6% BELVIQ-treated vs. 2.4% placebo-treated and suicidal ideation occurred in 0.6% BELVIQ-treated vs. 0.4% placebo-treated patients. 1.3% of BELVIQ patients vs. 0.6% of placebo patients discontinued drug due to depression-, mood-, or suicidal ideation-related events.
Lymphocyte and Neutrophil Counts. In clinical trials of at least 1-year duration, lymphocyte counts were below the lower limit of normal in 12.2% of patients taking BELVIQ and 9.0% taking placebo, and neutrophil counts were low in 5.6% and 4.3%, respectively.
Hemoglobin. In clinical trials of at least 1-year duration, 10.4% of patients taking BELVIQ and 9.3% taking placebo had hemoglobin below the lower limit of normal at some point during the trials.
Prolactin. In clinical trials, 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, 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.
More patients on BELVIQ reported an eye disorder than patients on placebo in clinical trials of patients without diabetes (4.5% vs. 3.0%) and with type 2 diabetes (6.3% vs. 1.6%). In the population without diabetes, events of blurred vision, dry eye, and visual impairment occurred in BELVIQ-treated patients at an incidence greater than that of placebo. In the population with type 2 diabetes, visual disorders, conjunctival infections, irritations, and inflammations, ocularsensation disorders, and cataract conditions occurred in BELVIQ-treated patients at an incidence greater than placebo.
Echocardiographic Safety Assessments
The possible occurrence of regurgitant cardiac valve disease was prospectively evaluated in 7794 patients in three clinical trials of at least one year in duration, 3451 of whom took BELVIQ 10 mg twice daily. The primary echocardiographic safety parameter was the proportion of patients who developed echocardiographic criteria of mild or greater aortic insufficiency and/or moderate or greater mitral insufficiency from baseline to 1 year. At 1 year, 2.4% of patients who received BELVIQ and 2.0% of patients who received placebo developed valvular regurgitation. The relative risk for valvulopathy with BELVIQ is summarized in Table 4. BELVIQ was not studied in patients with congestive heart failure or hemodynamically-significant valvular heart disease.
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