The Washington Post (3/6, Johnson, McGinley) reports that the FDA has “approved a novel antidepressant — the first in decades to work in a completely new way in the brain — for people with depression that does not respond to other treatments.” The medication, “a nasal spray called esketamine, has been eagerly anticipated by psychiatrists and patient groups as a powerful new tool to fight intractable depression.” According to the Post, “The spray acts within hours, rather than weeks or months as is typical for current antidepressants.” Reuters (3/5) reports that “the treatment comes with a boxed warning…flagging the risk for sedation and difficulty with attention, judgment and thinking, abuse and misuse, and suicidal thoughts after administration of the” medication. Meanwhile, the agency, “citing the risk of serious adverse outcomes and the potential for abuse and misuse…said the drug will be available through a restricted distribution system.” The AP (3/6, Perrone) reports that “the FDA approved” the medication “based on study results that showed patients taking the drug experienced a bigger improvement in their depression levels than patients taking a sham treatment, when measured with a psychiatric questionnaire.” The medication “is designed to be lower-dose and easier to use than ketamine, which is normally given as an intravenous infusion.” According to the AP, “The nasal spray…is a chemical cousin of ketamine, which has been used for decades as a powerful anesthetic to prepare patients for surgery.” The New York Times (3/5, Carey) reports, “Ketamine was developed more than five decades ago as a safer alternative to the anesthetic phencyclidine, or PCP, and is used worldwide, in operating rooms, on the battlefield and in pediatric clinics.” According to the Times, “By the 1990s, interest turned to the drug’s potential to combat depression.” HealthDay (3/5, Miller, Mundell) reports that “low, intravenous doses” of ketamine “have been found to boost mood and curb suicidal thoughts, but the FDA has not approved it as a treatment for depression.” According to HealthDay, “the American Psychiatric Association (APA) warns patients about the potential for abuse and the lack of large, long-term studies of its effectiveness.” Former APA President Dr. Alan Schatzberg said, “The lack of information [on ketamine] is really quite dramatic when you look at the proliferation of use in certain communities.”(SOURCE: APA Headlines)
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