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Fetzima (Levomilnacipran Hydrochloride) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

The following adverse reactions are discussed in greater detail in other sections of the label.

  • Hypersensitivity [see Contraindications (4)]
  • Suicidal Thoughts and Behaviors in Adolescents and Young Adults [see Warnings and Precautions ]
  • Serotonin Syndrome [see Warnings and Precautions]
  • Elevated Blood Pressure [see Warnings and Precautions ]
  • Elevated Heart Rate [see Warnings and Precautions]
  • Abnormal Bleeding [see Warnings and Precautions ]
  • Angle Closure Glaucoma [see Warnings and Precautions]
  • Urinary Hesitation or Retention [see Warnings and Precautions ]
  • Activation of Mania/Hypomania [see Warnings and Precautions]
  • Seizure [see Warnings and Precautions (5.9)]
  • Discontinuation Syndrome [see Warnings and Precautions ]
  • Hyponatremia [see Warnings and Precautions]

Clinical Studies Experience

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 studies of another drug and may not reflect the rates observed in clinical practice.

Patient exposure

The safety of FETZIMA was evaluated in 2,673 patients (18-78 years of age) diagnosed with MDD who participated in clinical studies, representing 942 patient-years of exposure. Among the 2,673 FETZIMA-treated patients, 1,583 were exposed to FETZIMA in short-term, placebo-controlled studies. There were 825 patients who continued from short-term studies into a one-year, open-label extension study.

Of the 2,673 patients exposed to at least one dose of FETZIMA, 737 patients were exposed to FETZIMA for at least 6 months and 367 were exposed for one year. In these studies FETZIMA was given at doses ranging from 40-120 mg once daily and was given without regard to food.

Adverse reactions reported as reasons for discontinuation of treatment

In the short-term placebo-controlled pre-marketing studies for MDD, 9% of the 1,583 patients who received FETZIMA (40-120 mg) discontinued treatment due to an adverse event, compared with 3% of the 1,040 placebo-treated patients in those studies. The most common adverse reaction leading to discontinuation in at least 1% of the FETZIMA-treated patients in the short-term placebo-controlled studies was nausea (1.5%).

Common adverse reactions in placebo-controlled MDD studies

The most commonly observed adverse events in FETZIMA-treated MDD patients in placebo-controlled studies (incidence ≥ 5% and at least twice the rate of placebo) were: nausea, constipation, hyperhidrosis, heart rate increased, erectile dysfunction, tachycardia, vomiting, and palpitations.

Table 3 shows the incidence of adverse reactions that occurred in ≥ 2% of FETZIMA-treated MDD patients and at least twice the rate of placebo in the placebo-controlled studies.

Table 3 Adverse Reactions Occurring in ≥ 2% of FETZIMA-treated Patients and at Least Twice the rate of Placebo-treated Patients

a Tachycardia also includes: sinus tachycardia and postural orthostatic tachycardia syndrome

b Percentage is relative to the number of patients in the associated demographic sex category. Fewer than 2% of FETZIMA-treated MDD female patients in placebo-controlled clinical studies reported adverse events related to sexual function.

c erectile dysfunction includes: erectile dysfunction, organic erectile dysfunction and psychogenic erectile dysfunction

d testicular pain includes: testicular pain, epididymitis, and seminal vesiculitis

e ejaculation disorder includes: ejaculation disorder, ejaculation delayed, ejaculation failure, and premature ejaculation

f Heart rate increased also includes: orthostatic heart rate response increased

g Blood pressure increased also includes: blood pressure systolic increased, blood pressure diastolic increased and blood pressure orthostatic increased

h Rash also includes: rash generalized, rash maculo-papular, rash erythematous and rash macular

i Hypotension also includes: orthostatic hypotension and dizziness postural

j Hypertension also includes: labile hypertension

N = number of patients in the Safety Population

System Organ Class
Preferred Term
Placebo
(N =1040)
%
FETZIMA
40-120 mg/d

(N = 1583)
%
Gastrointestinal disorders
Nausea 6 17
Constipation 3 9
Vomiting 1 5
Cardiac disorders
Tachycardiaa 2 6
Palpitations 1 5
Reproductive system and breast disorders b
Erectile dysfunctionc 1 6
Testicular paind <1 4
Ejaculation disordere <1 5
Investigations
Heart rate increasedf 1 6
Blood pressure increasedg 1 3
Renal and urinary disorders
Urinary hesitation 0 4
Skin and subcutaneous tissue disorders
Hyperhidrosis 2 9
Rashh 0 2
Vascular disorders
Hot flush 1 3
Hypotensioni 1 3
Hypertensionj 1 3
Metabolism and nutrition disorders
Decreased appetite 1 3

Dose-related adverse reactions

In pooled data from the short-term placebo-controlled fixed-dose studies, there were no dose-related adverse reactions (greater than 2% overall incidence) in patients treated with FETZIMA across the dose range 40-120 mg once daily, with the exception of erectile dysfunction and urinary hesitation (see Table 4).

Table 4 Dose-Related Adverse Reactions

a Percentage is relative to the number of male patients.

N = number of patients in the Safety Population

System Organ Class
 Preferred Term
Placebo
(N = 362)
%
FETZIMA
40 mg/d
(N = 366)
%
80 mg/d
(N = 367)
%
120 mg/d
(N = 180)
%
Urinary hesitation 0 4 5 6
Erectile dysfunctiona 2 6 8 10

Other adverse reactions observed in clinical studies

Other infrequent adverse reactions, not described elsewhere in the label, occurring at an incidence of < 2% in MDD patients treated with FETZIMA were:

Cardiac disorders: Angina pectoris; Supraventricular and Ventricular extrasystoles

Eye disorders: Dry eye; Vision blurred; Conjunctival hemorrhage

General disorders: Chest pain; Thirst

Gastrointestinal disorders: Abdominal pain; Flatulence

Investigations disorders: Blood cholesterol increased; Liver function test abnormal

Nervous System disorders: Migraine; Paraesthesia; Syncope; Extrapyramidal disorder

Psychiatric disorders: Agitation; Anger; Bruxism; Panic attack; Tension; Aggression

Renal and Urinary disorder: Pollakiuria; Hematuria; Proteinuria

Respiratory, thoracic and mediastinal disorders: Yawning

Skin and subcutaneous tissue disorders: Dry skin; Pruritus; Urticaria

Drug label data at the top of this Page last updated: 2014-07-21

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