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Duloxetine: to be avoided in all circumstances

Despite its many potentially severe adverse effects and its modest or rather dubious efficacy, duloxetine is marketed for a range of indications.

Duloxetine is a psychotropic drug, marketed for various conditions (depression, some types of pain, stress urinary incontinence) despite an unfavourable risk-benefit balance.

The European Medicines Agency (EMEA) has rightly refused to extend the indications to fibromyalgia, but regrettably it has authorised general anxiety disorder as a new indication for duloxetine, despite the disproportionate risks to which it exposes patients in the absence of any tangible clinical benefits.

A report on the adverse effects of duloxetine, after 3 years on the market, supplied by the American Food and Drug Administration (FDA) reveals that in addition to its adverse neuropsychological, digestive and urinary effects, increased blood pressure and liver disease, duloxetine exposes patients to other worrying adverse effects: sometimes fatal haemorrhages, and imbalance in blood sodium levels resulting in falls and syncope.

These data confirm the fact that duloxetine exposes patients to even more adverse effects and drug interactions than other similar antidepressants. Prescrire advises doctors not to prescribe this drug.

©Prescrire February 2009

Source: "Duloxétine (Cymbalta°) Dans l'anxiété généralisée non plus" Rev Prescrire 2009; 29 (303): 9.

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