Duloxetine

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.

The information below summarises the safety profile of Cymbalta and Yentreve. This information should be read alongside the information given in the Summary of Product Characteristics and Patient Information Leaflet for Cymbalta and Yentreve, which can be found on the website of the European Medicines Agency:
› European Public Assessment Report for Cymbalta (external link)
› European Public Assessment Report for Yentreve (external link)

Cymbalta and Yentreve should be prescribed for their correct intended use, and should not be used together.

Side effects of Cymbalta and Yentreve
The most common side-effects of Cymbalta and Yentreve include: decreased appetite; insomnia or sleep disorders; anxiety; agitation; decreased sex-drive and other sexual disorders; headache; dizziness; tremor; paraesthesia; muscular pain or tightness; nervousness; tiredness; blurred vision; palpitations; hot flushes; yawning; nausea; dry mouth; constipation; diarrhoea; vomiting; indigestion; short-term liver injury; urinary disorders; and sweating. Patients who are concerned about the potential side-effects associated with Cymbalta or Yentreve should discuss their treatment with a doctor.

Up to Aug 6, 2007, 1632 side-effects associated with duloxetine have been reported spontaneously to the Medicines and Healthcare products Regulatory Agency. From the MHRA’s database, the most frequently reported side-effects were: nausea (117 reports); dizziness (69 reports); headache (51 reports); vomiting (46 reports); diarrhoea (41 reports); tremor (35 reports); fatigue (33 reports); insomnia (33 reports); excessive sweating (32 reports); drowsiness (28 reports); dry mouth (27 reports); suicidal ideation (27 reports); malaise (26 reports); anorexia (25 reports); blurred vision (25 reports); drug-withdrawal syndrome (23 reports); constipation (20 reports); urinary retention (20 reports); feeling abnormal (20 reports); and anxiety (18 reports). However, spontaneous reporting has limitations. For instance, some reports may have incomplete information, and reports cannot be used to determine the incidence of a particular adverse reaction for a given drug: not all adverse reactions will be reported, and reporting can be subject to bias (eg, through media coverage).

This is not a complete list of the potential side-effects for duloxetine: for further information healthcare professionals should refer to the Summary of Product Characteristics, and patients should refer to the Patient Information Leaflet that is given with the medicine.

Important safety information for Cymbalta and Yentreve

For both Cymbalta and Yentreve, it is important to remember that:

• Suicidal behaviour and suicidal ideation have been associated during, and after stopping, treatment with duloxetine. Patients who are prescribed Cymbalta and Yentreve, irrespective of the disorder for which it has been prescribed, should monitor and report any signs of depression, agitation, or suicidal thoughts to their doctor; such vigilance may be particularly important for young adults.
• The effectiveness and safety of Cymbalta and Yentreve has not been assessed in children and adolescents. Therefore, these medicines should not be prescribed to people younger than 18 years.
• Women who are pregnant or breastfeeding should not take Yentreve or Cymbalta.
• To minimise withdrawal reactions, patients should stop their course of treatment with Cymbalta or Yentreve by a gradual decrease in dose over at least 1–2 weeks.
• Cymbalta or Yentreve should not be prescribed to patients who have impaired liver function or liver disease.
• Cymbalta or Yentreve may increase blood pressure in some patients, and should not be prescribed to patients with uncontrolled blood pressure. Cymbalta and Yentreve should be prescribed with caution in those with high blood pressure or heart disease. Blood pressure should be monitored in these patients, particularly at the start of treatment.