Canadian  Duloxetine (Yentreve™, Eli Lilly/Boeh-ringer Ingelheim), has been granted marketing approval in the European Union for the treatment of moderate-to-severe stress urinary incontinence. Patients with this condition experience the accidental leakage of urine during physical activity.

Although stress urinary incontinence is common, it is not considered “normal” at any age. Risk factors include obesity, childbirth, chronic coughing, and constipation.

The drug is currently being evaluated by the FDA, which issued an approvable letter in August 2003. Approval from the agency is expected in 2005.

Approximately 15 million American adult women are affected by stress urinary incontinence.

Eli Lilly’s new antidepressant duloxetine (Canadian Cymbalta™) has been found to be effective in reducing pain in women with fibromyalgia.

In a 12-week study, 354 women took either duloxetine once or twice a day; the others took a placebo. More than half of the patients treated with 60 mg of the drug responded to treatment after the 12 weeks, but only one third of those taking placebo responded. Researchers stated that 44% of the patients taking the medication reported a sustained reduction in pain, compared with 19% taking a placebo.

Duloxetine medication is a dual serotonin-nor-epinephrine reuptake inhibitor. Some researchers believe that norepinephrine is mainly responsible for the effect on pain. The drug was approved in September for pain related to diabetic neuropathy.

Fibromyalgia affects about six million Americans, most of them women.

Eli Lilly and the FDA have notified health care professionals of a revision to the precautions/hepatotoxicity section of the prescribing information for duloxetine HCl (Cymbalta generic). This medication is indicated for the treatment of major depressive disorder and diabetic peripheral neuropathic pain.

Postmarketing reports of hepatic injury, hepatitis, and cholestatic jaundice suggest that patients with pre-existing liver disease who take duloxetine may have an increased risk for further liver damage. The new labeling extends the precaution against using this drug in patients with substantial alcohol use to include patients with chronic liver disease.

Duloxetine canadian should not be given to patients with hepatic insufficiency.