- Medicines and Healthcare products Regulatory Agency
- Therapeutic area:
- Endocrinology, diabetology and metabolism, Psychiatry, and Urology and nephrology
Patients should be assessed regularly due to reported cases of suicidal ideation and suicidal behaviour during treatment with duloxetine or shortly after stopping treatment.
Article date: September 2007
Duloxetine is a prescription-only medicine that is indicated for treatment of three different disorders—major depressive disorder, diabetic neuropathy, and stress urinary incontinence. For treatment of major depressive disorder and diabetic neuropathy, duloxetine is marketed as Cymbalta▼; for treatment of stress urinary incontinence, duloxetine is marketed as Yentreve▼.
Cases of suicidal ideation and suicidal behaviour have been reported during treatment with duloxetine or early on after stopping treatment. Patients and caregivers should monitor and report to their doctor any distressing thoughts or feelings, signs of depression, suicidal behaviour or ideation, or thoughts of self-harm if they occur at any time during or after treatment with Cymbalta or Yentreve; healthcare professionals should encourage patients to report any of these thoughts, feelings, or signs during treatment with Cymbalta or Yentreve.
- Cymbalta and Yentreve should be prescribed for their correct intended use, and should not be used together
- The benefit to the patient of taking Cymbalta for diabetic neuropathy should be assessed by a doctor at least every 3 months
- The benefit of Yentreve for patients with stress urinary incontinence should be assessed regularly
- Cymbalta or Yentreve should not be prescribed to patients who have: liver disease leading to impaired liver function; severe kidney impairment; uncontrolled hypertension
- Cymbalta or Yentreve should not be prescribed to patients who are also taking: non-selective, irreversible monoamine oxidase inhibitors for depression such as phenelzine (Nardil), isocarboxazid, or trancyclopromine; fluvoxamine for depression or obsessive compulsive disorder; or the antibiotic ciprofloxacin. Cymbalta should be used with caution alongside other antidepressants or St John’s Wort. The use of Yentreve in combination with antidepressants is not recommended
- Patients should avoid abrupt withdrawal of treatment from Cymbalta or Yentreve. Healthcare professionals should prescribe gradually reduced doses over at least 1–2 weeks to minimise withdrawal reactions. If a patient has intolerable symptoms after decreasing or stopping Cymbalta or Yentreve, the drug may be re-prescribed or the dose increased; any subsequent reductions in dose may be done more gradually
See also further information on Duloxetine.
Article citation: Drug Safety Update Sept 2007, vol 1 issue 2: 11.