, Vital Sign Changes). • Serum Lipids Increases in cholesterol (total and LDL) and triglycerides were observed in some patients treated with desvenlafaxine succinate in placebo-controlled pre-marketing clinical trials, particularly with higher doses.
Measurement of serum lipid levels should be considered during treatment. PRISTIQ® (desvenlafaxine succinate) Product Monograph Page 14 of 56 Musculoskeletal Epidemiological studies show an increased risk of bone fractures following exposure to some antidepressants, including SSRIs/SNRIs.
The risks appear to be greater at the initial stages of treatment, but significant increased risks were also observed at later stages of treatment. The possibility of fracture should be considered in the care of patients treated with PRISTIQ.
Elderly patients and patients with important risk factors for bone fractures should be advised of possible adverse events which increase the risk of falls, such as dizziness and orthostatic hypotension, especially at the early stages of treatment but also soon after withdrawal.
Preliminary data from observational studies show association of SSRIs/SNRIs and low bone mineral density in older men and women. Until further information becomes available, a possible effect on bone mineral density with long term treatment with SSRIs/SNRIs, including PRISTIQ, cannot be excluded, and may be a potential concern for patients with osteoporosis or major risk factors for bone fractures.
Neurologic • Seizures Cases of seizures have been reported in trials with PRISTIQ. Desvenlafaxine succinate should be prescribed with caution in patients with a seizure disorder. Desvenlafaxine has not been systematically evaluated in patients with a seizure disorder.
4 Drug-Drug Interactions, Serotonergic Agents). g. g. anxiety, agitation, hypomania). In accordance with the Hunter Criteria, serotonin toxicity diagnosis is likely when, in the presence of at least one serotonergic agent, one of the following is observed: • Spontaneous clonus • Inducible clonus or ocular clonus with agitation or diaphoresis • Tremor and hyperreflexia • Hypertonia and body temperature > 38°C and ocular clonus or inducible clonus.
Neuroleptic malignant syndrome has also been rarely reported with PRISTIQ, particularly during combined use with neuroleptic/antipsychotic drugs. The clinical manifestations of neuroleptic malignant syndrome often overlap with those of serotonin toxicity, including hyperthermia, hypertonia, altered mental status, and autonomic instability.
In contrast to serotonin toxicity, patients with neuroleptic malignant syndrome may present with “lead pipe” muscle rigidity as well as hyporeflexia. The concomitant use of PRISTIQ with MAOIs, including linezolid and methylthioninium chloride (methylene blue) is contraindicated (see 2 CONTRAINDICATIONS).
4 Drug-Drug Interactions, Serotonergic Agents). If concomitant treatment with PRISTIQ and other serotonergic agents is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases.
If serotonin toxicity is suspected, discontinuation of the serotonergic agents should be considered. Ophthalmologic • Angle-Closure Glaucoma As with other antidepressants, PRISTIQ can cause mydriasis, which may trigger an angle- closure attack in a patient with anatomically narrow ocular angles.
Healthcare providers should inform patients to seek immediate medical assistance if they experience eye pain, changes in vision or swelling or redness in or around the eye. Psychiatric • POTENTIAL ASSOCIATION WITH BEHAVIOURAL AND EMOTIONAL CHANGES, INCLUDING SELF-HARM.
• Pediatrics: Placebo-Controlled Clinical Trial Data Recent analyses of placebo-controlled clinical trial safety databases from Selective Serotonin Reuptake Inhibitors (SSRIs) and other newer anti-depressants suggest that use of these drugs in patients under the age of 18 may be associated with behavioural and emotional changes, including an increased risk of suicidal ideation and behaviour over that of placebo.
The small denominators in the clinical trial database, as well as the variability in placebo rates, preclude reliable conclusions on the relative safety profiles among the drugs in the class. PRISTIQ is not indicated for use in pediatric patients (see 1 INDICATIONS).
• Adults and Pediatrics: Additional data There are clinical trial and post-marketing reports with SSRIs and other newer antidepressants in both pediatrics and adults of severe agitation-type adverse events coupled with self-harm or harm to others.
The agitation-type events include: akathisia, agitation, disinhibition, emotional lability, hostility, aggression, depersonalization. In some cases, the events occurred within several weeks of starting treatment. An FDA meta-analysis of placebo-controlled clinical trials of antidepressant drugs in adult patients ages 18 to 24 years with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo.
Rigorous clinical monitoring for suicidal ideation or other indicators of potential for suicidal behaviour is advised in patients of all ages especially when initiating therapy or during any change in dose or dosage regimen. This includes monitoring for agitation-type emotional and […]