About a year ago, patients began trooping into the office of UCLA psychiatrist Andrew Leuchter, asking whether an antipsychotic drug called Abilify "might be right for them." Few appeared to be delusional, plagued by hallucinations or suffering fearsome mood swings. Mostly, they were depressed or anxious, and frustrated by the pace of their recovery.
Leuchter wondered what was up: Depressed patients didn't usually seek out drugs used to quell psychiatry's most disturbing symptoms.
What was up, he soon discovered, was spending on a new advertising campaign touting Abilify as an "add-on" treatment for depression. For the first time since the arrival of a new generation of antipsychotic medications -- six drugs called the "atypicals" because they work differently from the earlier generation of antipsychotic drugs -- the makers of one, Abilify, had been granted the legal right to market to a vast new population of patients beyond those with schizophrenia or bipolar disorder.
This week, a Food and Drug Administration advisory panel recommended that the agency should grant the makers of a second atypical antipsychotic drug -- Seroquel XR -- similar latitude. The drug giant AstraZeneca wants permission to market the drug as a treatment for depression or anxiety that has not yielded to antidepressants alone.
But this time, it wasn't quite so easy a sell. The panel did say the drug was safe and effective for such purposes when used with other drugs, recommending approval for its use as an "add-on" treatment. But the panel recommended against the drug as a stand-alone treatment. And this time, the panel -- echoing an issue expressed by the FDA in convening the meeting -- cited safety concerns about the drugs' use in a greatly expanded population of patients.
Mounting research has made clear that the atypical antipsychotics are not only less safe than originally thought; they are not, on balance, any safer or more effective than older drugs for schizophrenia. And for the population of depressed or anxious patients that some are now proposed to treat, studies suggest the benefits are extremely modest.
The accumulated findings on the larger group of drugs had prompted the FDA to ask its advisory panel whether expanding the population of patients taking Seroquel XR would be wise. Like other members of this class of drugs, Seroquel has been linked to weight gain extreme enough to cause diabetes and to an often irreversible disorder characterized by involuntary tics and jerking movements.
