Prescription Drug Information: Desvenlafaxine (Page 4 of 10)

Sexual Function Adverse Reactions

Table 3 shows the incidence of sexual function adverse reactions that occurred in ≥ 2% of desvenlafaxine extended-release tablets treated MDD patients in any fixed-dose group (pre-marketing pooled 8-week, placebo-controlled, fixed-dose, clinical studies).

Table 3: Sexual Function Adverse Reactions (≥ 2% in Men or Women in Any Desvenlafaxine Extended-Release Tablets Group) During the On-Therapy Period

Desvenlafaxine Extended-Release Tablets

Placebo

(n = 239)

50 mg

(n = 108)

100 mg

(n = 157)

200 mg

(n = 131)

400 mg

(n = 154)

Men only

Anorgasmia

0

0

3

5

8

Libido decreased

1

4

5

6

3

Orgasm abnormal

0

0

1

2

3

Ejaculation delayed

< 1

1

5

7

6

Erectile dysfunction

1

3

6

8

11

Ejaculation disorder

0

0

1

2

5

Ejaculation failure

0

1

0

2

2

Sexual dysfunction

0

1

0

0

2

Desvenlafaxine Extended-Release Tablets

Placebo

(n = 397)

50 mg

(n = 209)

100 mg

(n = 267)

200 mg

(n = 176)

400 mg

(n = 163)

Women only

Anorgasmia

0

1

1

0

3

Other Adverse Reactions Observed in Pre-marketing and Postmarketing Clinical Studies

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

Cardiac disorders — Tachycardia.

General disorders and administration site conditions — Asthenia.

Investigations — Weight increased, liver function test abnormal, blood prolactin increased. Musculoskeletal and connective tissue disorders — Musculoskeletal stiffness.

Nervous system disorders — Syncope, convulsion, dystonia.

Psychiatric disorders — Depersonalization, bruxism.

Renal and urinary disorders — Urinary retention.

Skin and subcutaneous tissue disorders — Rash, alopecia, photosensitivity reaction, angioedema.

In clinical studies, there were uncommon reports of ischemic cardiac adverse reactions, including myocardial ischemia, myocardial infarction, and coronary occlusion requiring revascularization; these patients had multiple underlying cardiac risk factors. More patients experienced these events during desvenlafaxine extended-release tablets treatment as compared to placebo.

Laboratory, ECG and Vital Sign Changes Observed in MDD Clinical Studies

The following changes were observed in pre-marketing placebo-controlled, short-term MDD studies with desvenlafaxine extended-release tablets.

Lipids

Elevations in fasting serum total cholesterol, LDL (low density lipoproteins) cholesterol, and triglycerides occurred in the controlled studies. Some of these abnormalities were considered potentially clinically significant.

The percentage of patients who exceeded a predetermined threshold value is shown in Table 4.

Table 4: Incidence (%) of Patients With Lipid Abnormalities of Potential Clinical Significance*

Desvenlafaxine Extended-Release Tablets

Placebo

50 mg

100 mg

200 mg

400 mg

Total Cholesterol

2

3

4

4

10

*(Increase of ≥ 50 mg/dl and an absolute value of ≥ 261 mg/dl)

LDL Cholesterol

0

1

0

1

2

*(Increase ≥ 50 mg/dl and an absolute value of ≥ 190 mg/dl)

Triglycerides, fasting

3

2

1

4

6

*(Fasting: ≥ 327 mg/dl)

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