What Are The Side Effects of Belviq

SIDE EFFECTS

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

Clinical Trials Experience

In the lorcaserin placebo-controlled clinical database of trials of at least one year in duration, of 6888 patients (3451 lorcaserin 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 immediate-release lorcaserin hydrochloride 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 lorcaserin 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 lorcaserin-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 lorcaserin 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 lorcaserin 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 Lorcaserin Patients and More Commonly than with Placebo in Patients without Diabetes Mellitus

Adverse ReactionNumber of patients (%)
Lorcaserin*
N=3195
Placebo
N=3185
Gastrointestinal Disorders
  Nausea264 (8.3)170 (5.3)
  Diarrhea207 (6.5)179 (5.6)
  Constipation186 (5.8)125 (3.9)
  Dry mouth169 (5.3)74 (2.3)
  Vomiting122 (3.8)83 (2.6)
General Disorders And Administration Site Conditions
  Fatigue229 (7.2)114 (3.6)
Infections And Infestations
  Upper respiratory tract infection439 (13.7)391 (12.3)
  Nasopharyngitis414 (13.0)381 (12.0)
  Urinary tract infection207 (6.5)171 (5.4)
Musculoskeletal And Connective Tissue Disorders
  Back pain201 (6.3)178 (5.6)
  Musculoskeletal pain65 (2.0)43 (1.4)
Nervous System Disorders
  Headache537 (16.8)321 (10.1)
  Dizziness270 (8.5)122 (3.8)
Respiratory, Thoracic And Mediastinal Disorders
  Cough136 (4.3)109 (3.4)
  Oropharyngeal pain111 (3.5)80 (2.5)
  Sinus congestion93 (2.9)78 (2.4)
Skin And Subcutaneous Tissue Disorders
  Rash67 (2.1)58 (1.8)
* Immediate-release lorcaserin hydrochloride, 10 mg twice daily

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

Adverse ReactionNumber of patients (%)
Lorcaserin*
N=256
Placebo
N=252
Gastrointestinal Disorders
  Nausea24 (9.4)20 (7.9)
  Toothache7 (2.7)0
General Disorders And Administration Site Conditions
  Fatigue19 (7.4)10 (4.0)
  Peripheral edema12 (4.7)6 (2.4)
Immune System Disorders
  Seasonal allergy8 (3.1)2 (0.8)
Infections And Infestations
  Nasopharyngitis29 (11.3)25 (9.9)
  Urinary tract infection23 (9.0)15 (6.0)
  Gastroenteritis8 (3.1)5 (2.0)
Metabolism And Nutrition Disorders
  Hypoglycemia75 (29.3)53 (21.0)
  Worsening of diabetes mellitus7 (2.7)2 (0.8)
  Decreased appetite6 (2.3)1 (0.4)
Musculoskeletal And Connective Tissue Disorders
  Back pain30 (11.7)20 (7.9)
  Muscle spasms12 (4.7)9 (3.6)
Nervous System Disorders
  Headache37 (14.5)18 (7.1)
  Dizziness18 (7.0)16 (6.3)
Psychiatric Disorders
  Anxiety9 (3.5)8 (3.2)
  Insomnia9 (3.5)6 (2.4)
  Stress7 (2.7)3 (1.2)
  Depression6 (2.3)5 (2.0)
Respiratory, Thoracic And Mediastinal Disorders
  Cough21 (8.2)11 (4.4)
Vascular Disorders
  Hypertension13 (5.1)8 (3.2)
* Immediate-release lorcaserin hydrochloride, 10 mg twice daily

Other Adverse Reactions

Serotonin-associated Adverse Reactions

SSRIs, SNRIs, bupropiontricyclic antidepressants, and MAOIs were excluded from the lorcaserin 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 lorcaserin 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 lorcaserin 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 XR 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, severe hypoglycemia (requiring the assistance of another person, requiring intravenous glucose, or hospitalization) occurred in 4 (1.6%) of lorcaserin-treated patients and in 1 (0.4%) placebo-treated patient. Of these 4 lorcaserin-treated patients, all were concomitantly using a sulfonylurea (with or without metformin). Lorcaserin 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%) lorcaserin-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 lorcaserin and 0.7% of patients taking placebo.

Psychiatric Disorders

Psychiatric disorders leading to hospitalization or drug withdrawal occurred more frequently in patients treated with lorcaserin (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 lorcaserin (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 lorcaserin 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% lorcaserin-treated vs. 2.4% placebo-treated and suicidal ideation occurred in 0.6% lorcaserintreated vs. 0.4% placebo-treated patients. 1.3% of lorcaserin 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 lorcaserin 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 lorcaserin 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 lorcaserintreated patients and 4.8%, 0.8%, and 0.0% of placebo-treated patients, respectively.

Eye disorders

More patients on lorcaserin 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 (5.9% vs. 1.6%). In the population without diabetes, events of blurred vision, dry eye, and visual impairment occurred in lorcaserin-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 lorcaserin-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 immediate-release lorcaserin hydrochloride 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 lorcaserin and 2.0% of patients who received placebo developed valvular regurgitation. The relative risk for valvulopathy with lorcaserin is summarized in Table 4. Lorcaserin was not studied in patients with congestive heart failure or hemodynamically-significant valvular heart disease [see WARNINGS AND PRECAUTIONS].

What Are The Side Effects of Belviq

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