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Belviq

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Belviq

Side Effects
Interactions

SIDE EFFECTS

The following important adverse reactions are described below and elsewhere in labeling:

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).

Table 2: Adverse Reactions Reported by Greater Than or Equal to 2% of BELVIQ Patients and More Commonly than with Placebo in Patients without Diabetes Mellitus

Adverse Reaction Number of patients (%)
BELVIQ 10 mg BID
N=3195
Placebo
N=3185
Gastrointestinal Disorders
  Nausea 264 (8.3) 170 (5.3)
  Diarrhea 207 (6.5) 179 (5.6)
  Constipation 186 (5.8) 125 (3.9)
  Dry mouth 169 (5.3) 74 (2.3)
  Vomiting 122 (3.8) 83 (2.6)
General Disorders And Administration Site Conditions
  Fatigue 229 (7.2) 114 (3.6)
Infections And Infestations
  Upper respiratory tract infection 439 (13.7) 391 (12.3)
  Nasopharyngitis 414 (13.0) 381 (12.0)
  Urinary tract infection 207 (6.5) 171 (5.4)
Musculoskeletal And Connective Tissue Disorders
  Back pain 201 (6.3) 178 (5.6)
  Musculoskeletal pain 65 (2.0) 43 (1.4)
Nervous System Disorders
  Headache 537 (16.8) 321 (10.1)
  Dizziness 270 (8.5) 122 (3.8)
Respiratory, Thoracic And Mediastinal Disorders
  Cough 136 (4.3) 109 (3.4)
  Oropharyngeal pain 111 (3.5) 80 (2.5)
  Sinus congestion 93 (2.9) 78 (2.4)
Skin And Subcutaneous Tissue Disorders
  Rash 67 (2.1) 58 (1.8)

Table 3: Adverse Reactions Reported by Greater Than or Equal to 2% of BELVIQ Patients and More Commonly than with Placebo in Patients with Type 2 Diabetes Mellitus

Adverse Reaction Number of patients (%)
BELVIQ 10 mg BID
N=256
Placebo
N=252
Gastrointestinal Disorders
  Nausea 24 (9.4) 20 (7.9)
  Toothache 7 (2.7) 0
General Disorders And Administration Site Conditions
  Fatigue 19 (7.4) 10 (4.0)
  Peripheral edema 12 (4.7) 6 (2.4)
Immune System Disorders
  Seasonal allergy 8 (3.1) 2 (0.8)
Infections And Infestations
  Nasopharyngitis 29 (11.3) 25 (9.9)
  Urinary tract infection 23 (9.0) 15 (6.0)
  Gastroenteritis 8 (3.1) 5 (2.0)
Metabolism And Nutrition Disorders
  Hypoglycemia 75 (29.3) 53 (21.0)
  Worsening of diabetes mellitus 7 (2.7) 2 (0.8)
  Decreased appetite 6 (2.3) 1 (0.4)
Musculoskeletal And Connective Tissue Disorders
  Back pain 30 (11.7) 20 (7.9)
  Muscle spasms 12 (4.7) 9 (3.6)
Nervous System Disorders
  Headache 37 (14.5) 18 (7.1)
  Dizziness 18 (7.0) 16 (6.3)
Psychiatric Disorders
  Anxiety 9 (3.5) 8 (3.2)
  Insomnia 9 (3.5) 6 (2.4)
  Stress 7 (2.7) 3 (1.2)
  Depression 6 (2.3) 5 (2.0)
Respiratory, Thoracic And Mediastinal Disorders
  Cough 21 (8.2) 11 (4.4)
Vascular Disorders
  Hypertension 13 (5.1) 8 (3.2)

Other Adverse Reactions

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 [see WARNINGS AND PRECAUTIONS].

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.

Cognitive Impairment

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

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.

Laboratory Abnormalities

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.

Eye disorders

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, ocular sensation 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 [see WARNINGS AND PRECAUTIONS].

Table 4: Incidence of FDA-Defined Valvulopathy at Week 52 by Treatment Group1

  Study 1 Study 2 Study 3
BELVIQ
N=1278
Placebo
N=1191
BELVIQ
N=1208
Placebo
N=1153
BELVIQ
N=210
Placebo
N=209
FDA-defined Valvulopathy, n (%) 34 (2.7) 28 (2.4) 24 (2.0) 23 (2.0) 6 (2.9) 1 (0.5)
Relative Risk (95% CI) 1.13 (0.69, 1.85) 1.00 (0.57, 1.75) 5.97 (0.73, 49.17)
Pooled RR (95% CI) 1.16 (0.81, 1.67)
1Patients without valvulopathy at baseline who received study medication and had a post-baseline echocardiogram; ITT-intention-to-treat; LOCF-last observation carried forward

Read the Belviq (lorcaserin hydrochloride) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Use with Other Agents that Affect Serotonin Pathways

Based on the mechanism of action of BELVIQ and the theoretical potential for serotonin syndrome, use with extreme caution in combination with other drugs that may affect the serotonergic neurotransmitter systems, including, but not limited to, triptans, monoamine oxidase inhibitors (MAOIs, including linezolid, an antibiotic which is a reversible non-selective MAOI), selective serotonin reuptake inhibitors (SSRIs), selective serotonin-norepinephrine reuptake inhibitors (SNRIs), dextromethorphan, tricyclic antidepressants (TCAs), bupropion, lithium, tramadol, tryptophan, and St. John's Wort [see WARNINGS AND PRECAUTIONS].

Cytochrome P450 (2D6) substrates

Use caution when administering BELVIQ together with drugs that are CYP 2D6 substrates, as BELVIQ can increase exposure of these drugs [see CLINICAL PHARMACOLOGY].

Drug Abuse And Dependence

Abuse

In a human abuse potential study in recreational drug abusers, supratherapeutic oral doses of lorcaserin (40 and 60 mg) produced up to two- to six-fold increases on measures of “High”, “Good Drug Effects”, “Hallucinations” and “Sedation” compared to placebo. These responses were similar to those produced by oral administration of the positive control drugs, zolpidem (15 and 30 mg) and ketamine (100 mg). In this study, the incidence of the adverse reaction of euphoria following lorcaserin administration (40 and 60 mg; 19%) is similar to the incidence following zolpidem administration (13-16%), but less than the incidence following ketamine administration (50%). The duration of euphoria following lorcaserin administration persisted longer ( > 9 hours) than that following zolpidem (1.5 hours) or ketamine (2.5 hours) administration.

Overall, in short-term studies with healthy individuals, the rate of euphoria following oral administration of lorcaserin was 16% following 40 mg (n = 11 of 70) and 19% following 60 mg (n = 6 of 31). However, in clinical studies with obese patients with durations of 4 weeks to 2 years, the incidence of euphoria and hallucinations following oral doses of lorcaserin up to 40 mg was low ( < 1.0%).

Dependence

There are no data from well-conducted animal or human studies that evaluate whether lorcaserin can induce physical dependence, as evidenced by a withdrawal syndrome. However, the ability of lorcaserin to produce hallucinations, euphoria, and positive subjective responses at supratherapeutic doses suggests that lorcaserin may produce psychic dependence.

Last reviewed on RxList: 7/5/2012
This monograph has been modified to include the generic and brand name in many instances.

Side Effects
Interactions
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