Elevated blood pressure by tduloxetine (YENTREVE, CYMBALTA): A 66-year old woman with stress incontinence woke up at night with anxiety, agitation, palpitations, visual disturbances, dizziness with staggering, dry mouth and increased urge to urinate after taking one (duloxetine tablet (YENTREVE, a-t 2004; 35: 120). The blood pressure (BP) increased up to 200/120 mmHg. After the serotonin-noradrenaline reuptake inhibitor (SNRI) was stopped, she "recovered completely" (NETZWERK report 13.451). According to an American report evaluating duloxetine as an antidepressant**, a dose-dependent increase in blood pressure is noted at combined evaluation of safety data from studies of depression and stress incontinence. Increased systolic BP are found in up to 24% (placebo 9%) and increased diastolic BP in up to 19% (placebo 8%) on duloxetine (FDA: Med. Review CYMBALTA; http://www.fda.gov/cder/foi/nda/2004/021427_s000_Cymbalta.htm). Regular blood pressure controls are therefore recommended in the American summary of product characteristics (SPC; http://pi.lilly.com/us/cymbalta-pi.pdf). In the German duloxetine SPC, which is on the market as an antidepressant since February (CYMBALTA), the rise in blood pressure, also described for other SNRIs such as venlafaxine (TREVILOR) and sibutramine, which is marketed as an appetite suppressant (REDUCTIL; a-t 2003; 34: 88), is not at all mentioned (Boehringer Ingelheim/Lilly: SPC YENTREVE, version of August 2004; CYMBALTA, version of December 2004). Only in the SPC of CYMBALTA there is a reference to "appropriate blood pressure monitoring" in "patients with known high blood pressure and/or other cardiac diseases". We consider this reference nebulous and inadequate, -ed.

*

STOP-NIDDM = Study To Prevent Non-insulin-dependent diabetes mellitus

**

In the USA Lilly withdrew the application for a licence in incontinence in January 2005 (a-t 2005; 36: 23).