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Cites suicidality, worsening depression: FDA wants to strengthen warnings on 10 antidepressants.(News)
The Food and Drug Administration has asked the manufacturers of 10 antidepressant drugs to include on their labels stronger warnings about the need to monitor adult and pediatric patients for symptoms of worsening depression and the emergence of suicidal ideation.
The proposed new warnings also alert prescribers, patients, and their caregivers to the emergence of symptoms that are known to be associated with antidepressants in some patients: anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia, hypomania, and mania. (See box.) A causal link has not been established between the emergence of such symptoms and either worsening of depression or suicidal impulses, but medications may need to be discontinued when such symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms.
The FDA wants the new warnings on the labels of fluoxetine (Prozac), sertraline (Zoloft) paroxetine (Paxil), fluvoxamine (Luvox), citalopram (Celexa), escitalopram (Lexapro), bupropion (Wellbutrin), venlafaxine (Effexor), nefazodone (Serzone), and mirtazapine (Remeron). Letters were sent out to the companies in late March, and manufacturers are expected to institute the changes within 30 days of receipt. Dr. Russell Katz, director of FDA's Division of Neuropharmacological Drug Products, said in a teleconference.
The proposed warnings also cite the potential of antidepressants for inducing manic episodes in patients with bipolar disorder.
"It's known that the first episode of bipolar disorder is often a depressive one," Dr. Katz said. "If you treat this with antidepressants, you have the potential for invoking a manic episode, especially if you're treating with an antidepressant alone. The warning will remind physicians to take a ...
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