The US Food and Drug Administration last week reiterated its warning that adults treated with antidepressants must be closely observed by their doctors in case they experience worsening of depression and "increased suicidal thinking or behavior."
Agency officials simultaneously posted new information that a "higher than expected rate of suicide attempts was observed" among patients taking the antidepressant duloxetine (manufactured by Eli Lilly and marketed in the United States as Cymbalta).
Eli Lilly has objected to the FDA’s warning about duloxetine. According to a report in the Wall Street Journal (1 July; sect B: 3), Dr Steve Galson, acting director of the FDA’s drug centre, said that the company had "raised legal issues, including our use of confidential commercial information."
The FDA said that it launched a review of antidepressants after an article was published in the BMJ in February (2005;330:396) showing that adults taking selective serotonin reuptake inhibitors were twice as likely to attempt suicide as those taking a placebo. The agency has asked that manufacturers supply data from all placebo controlled studies of antidepressants.
In view of the current concerns, the FDA issued a public health advisory statement on 1 July warning that "adults being treated with any type of antidepressant medication, particularly those being treated for depression, should be watched closely for worsening of depression and for increased suicidal thinking or behavior."
The new public health advisory statement comes after an October 2004 decision by the FDA ordering companies to place "black box" notices on the labels of all antidepressants warning against their use among children and adolescents, because of a risk of greater suicidality among children and adolescents using such drugs.
Duloxetine, which is marketed in Europe as Yentreve when used for the treatment of stress urinary incontinence, failed to win approval from the FDA for that condition in the US, causing Eli Lilly to withdraw its application for this indication in January. The FDA said that studies of women using the drug for incontinence showed that the risk of suicidality among the women was twice that in the general population of middle aged women in the US.
The FDA issued a statement saying that a "higher than expected rate of suicide attempts was observed in the open-label extensions of controlled studies of Cymbalta for stress urinary incontinence in women." It added: "An increased rate of suicidality was not seen in controlled trials of Cymbalta for treatment of depression or diabetic neuropathic pain [the approved indications for Cymbalta]. Cymbalta is not approved for the treatment of SUI [stress urinary incontinence]."
The agency said that it is continuing to evaluate "additional data to determine the relationship, if any, between suicidality and Cymbalta use." The agency estimates that its review will take up to a year to complete.