New Drug Approval
FDA Approves Cymbalta for Major Depression
The FDA recently approved duloxetine (Cymbalta) for treating
Duloxetine is believed to work by blocking reabsorption, or
reuptake, of the neurotransmitters serotonin and norepinephrine,
allowing these chemicals to persist at higher levels in the brain.
Four trials in a total of 1,059 adults with major depression
found the drug was superior to placebo in improving symptoms
of depression. The safety of the drug was evaluated in trials
including 2,418 patients. The most common side effects reported
included nausea, dry mouth, constipation, poor appetite, fatigue,
sleepiness, and increased sweating. As with most other antidepressants,
patients beginning therapy with or changing dosages of duloxetine
should be monitored for suicidal thoughts or behaviors.
Patients with uncontrolled narrow-angle glaucoma should not
take the drug, and it should not be taken along with antidepressant
drugs known as monoamine oxidase (MAO) inhibitors, the manufacturer
The recommended daily dosage of duloxetine is 40 to 60 mg, given
in one or two doses.
Approved by the FDA
August 4, 2004