As for Abilify, Sonia Choi, a Bristol-Myers Squibb spokeswoman, said the company "is continually monitoring the safety of Abilify, including the metabolic data, as part of our regular practice and is committed to disclosing clinical trials results" on the medication as they become available.
The concerns expressed by the FDA and its advisory panel, many public health experts say, come too late. In less than a decade, physicians have embraced the broad use of the atypical antipsychotics to treat mental disorders far less severe than schizophrenia and bipolar disorder -- afflictions such as anxiety, sleep difficulties, depression, attention deficit disorder and autism. First prescribed almost exclusively to adults, the drugs are now often used in the treatment of adolescents and kids as young as 2.
The sales of atypical antipsychotics have skyrocketed in recent years, propelling overall sales of antipsychotic drugs past all other classes, to $14.6 billion in 2008, according to IMS Health, a private firm that tracks drug trends. In 2008, 50 million prescriptions for antipsychotics, mostly the new ones, were filled in the U.S. -- a 5% hike in one year alone.
In the process, the spreading use of these costly drugs is raising -- for the nation as well as individual patients -- the rates and the risks of weight gain, diabetes, strokes, fatal heart attacks, an array of movement disorders and potentially, suicide, according to a wide range of critics.
"This is very worrisome; frankly I have serious concerns about these drugs," says Dr. Steven Nissen, who is chairman of the Cleveland Clinic's cardiovascular medicine department and serves as an ad hoc advisor for FDA panels. Studies point to a "very questionable balance between efficacy and safety" for the class, he said. But that message, he said, has been lost in an apparent "marketing bonanza" for the companies that make the medications. A recent report by the consulting firm Decision Resources found the makers of the atypicals spent $993 million in 2006 to promote the drugs to doctors and patients.
That's not to say the drugs haven't helped people.
Leuchter, who has prescribed Abilify for some with treatment-resistant depression, says that for certain patients and in certain circumstances, it works. "These are very effective medications, and like all medications, they have side effects," he says. But he adds: "I wouldn't want people to think this is the first thing they should reach for when a patient doesn't respond well to first-line antidepressants."
