Burnett’s doctor prescribed an antidepressant for an off-label use, which means that the drug was given for a purpose other than the one for which it was approved by the FDA. Because the drug was tested as an antidepressant, its efficacy as a sleeping pill was never established, and its effects on someone who is not depressed were never documented. The rapid growth in off-label prescribing of antidepressants—the practice increased 13 percent from 1996 to 2007—is one reason for the explosive increase in antidepressant sales. And women are often on the receiving end of these off-label prescriptions, commonly given for health issues that disproportionately affect them, such as sleep problems, hot flashes, chronic pain, migraines, fibromyalgia and PMS, according to a study in the Journal of Clinical Psychiatry.
Off-label prescribing is legal, ethical and widespread; one of the pluses is that it allows MDs some leeway in treating tricky conditions. But there are many situations in which other kinds of FDA-approved treatments work better than antidepressants used off-label. (See chart, page 126, “What Works and What Doesn’t.”) So why would a physician try an antidepressant off-label instead of a drug thoroughly vetted for the purpose?
One possibility is that some doctors are misinformed. A recent study discovered that many psychiatrists and primary care physicians believe there’s evidence to support off-label uses when there is actually very little or none. “In some cases, doctors even thought a drug had FDA approval for a particular use when it’s known to be ineffective for that purpose,” says Caleb G. Alexander, MD, codirector of the Johns Hopkins Center for Drug Safety and Effectiveness.
In addition, doctors may opt for lower risk over proven effectiveness. For instance, in treating insomnia, “many doctors are wary of benzodiazepines, the class of approved sleep drugs, because they can cause addiction if they’re overused,” says W. Vaughn McCall, MD, chair of psychiatry and health behavior at the Medical College of Georgia in Augusta. The dose of tricyclics that doctors typically prescribe for insomnia (as well as for migraine prevention, chronic pain and fibromyalgia) is far lower than what they’d use to treat depression, so while the medication can still cause troublesome side effects, it’s unlikely a patient would overdose.
Dealing with hot flashes also requires a risk-benefit analysis. Although estrogen is the most effective treatment and the only one that’s FDA approved, many women can’t or don’t want to use it because of the hormone’s potential to increase the risk of breast cancer. For that reason, doctors often prescribe, off-label, an SSRI or SNRI (serotonin-norepinephrine reuptake inhibitor).
Concern No. 2
Antidepressants may not be the best way to treat depression
You might think taking antidepressants for persistent low moods is a no-brainer, and the FDA has approved their use for that purpose, but don’t assume these drugs will effectively relieve depression, which affects almost twice as many women as men. A review of 30 years of data in the Journal of the American Medical Association(JAMA) found that SSRIs, the most frequently prescribed antidepressants, don’t work much better than a placebo for people whose depression is simply mild to moderate. “They’re only truly effective for people with very serious depression,” says Irving Kirsch, PhD, associate director of the program in placebo studies at Harvard Medical School. The majority of depressed people who take them feel better. “But that’s because they believe the medication will work, not because it’s a chemical cure,” Kirsch asserts. (Many psychiatrists disagree with Kirsch and point to flaws they see in the relevant research.)