"The first antidepressant to be introduced since FDA investigations into suicide/antidepressant links, Cymbalta itself was marred with suicides before it was approved. Five (deaths) occurred during Cymbalta clinical trials.
"Including previously healthy volunteer, Traci Johnson who hung herself in Lilly's Indiana University Medical School lab in 2004."
"Last May, the FDA ordered Lilly to add a black box to Cymbalta warning about suicides and antidepressants in young adults."
"Patients on antidepressants and their families or caregivers should watch for worsening depression symptoms, unusual changes in behavior, thoughts of suicide, anxiety, agitation, panic attacks, difficulty sleeping, irritability, hostility, aggressiveness, impulsivity, restlessness, or extreme hyperactivity. Call your healthcare provider right away if you have thoughts of suicide or if any of these symptoms are severe or occur suddenly. Be especially observant within the first few months of antidepressant treatment or whenever there is a change in dose."
"Suicidal thoughts or actions: Persons taking Cymbalta may be more likely to think about killing themselves or actually try to do so, especially when Cymbalta is first started or the dose is changed. People close to persons taking Cymbalta can help by paying attention to changes in user's moods or actions. Contact your healthcare professional right away if someone using Cymbalta talks about or shows signs of killing him or herself. If you are taking Cymbalta yourself and you start thinking about killing yourself, tell your healthcare professional about this side effect right away."
"And in October Lilly was told [by the FDA] to "immediately cease" its Cymbalta campaign for diabetic nerve pain --an approved use-- which promises "significantly less pain interference with overall functioning." In a letter, the FDA says the claim "has not been demonstrated by substantial evidence or ... clinical experience" nor do the Cymbalta marketing pieces give precautions about liver toxicity or reveal risks for patients with certain conditions."
Martha Rosenberg is an author and investigative writer that has appeared in the Chicago Tribune, L.A. Times, San Francisco Chronicle, Boston Globe, Providence Journal, Arizona Republic, New Orleans Times-Picayune and other newspapers.
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