Yesterday the FDA issued a new warning for antidepressants that sets a disturbing regulatory precedent. Its advisory says: "Health care providers should carefully monitor patients receiving antidepressants for possible worsening of depression and suicidality, especially at the beginning of therapy or when the dose either increases or decreases." The FDA is asking drug companies to include a prominent warning about suicide risk in their labeling.
But as The New York Times notes, there is little evidence that drugs such as Prozac and Paxil drive people to kill themselves:
Top F.D.A. officials have long insisted that their decisions are driven only by clear-cut evidence from well-run clinical trials. But in a conference call with reporters yesterday, agency officials said that no studies had shown a convincing link between drug therapy and suicide. Suicide is such a rare side effect that studies on the subject have been difficult to interpret, the regulators said.
Still, the agency issued the advisory anyway.
"It warns physicians that patients' depression may become worse," said Dr. Russell Katz, the agency's chief of neurological drugs, "that they may develop suicidal thinking or behavior after the initiation of treatment."
A series of secret studies, which were conducted by drug companies and became public last year, seemed to show that depressed children and teenagers given antidepressants were more likely to become suicidal than those given placebos. The studies also showed that most antidepressants were not effective in treating depression in children and teenagers. Those studies are still under review at the agency.
Nevertheless, a scientific advisory panel urged the agency last month to issue stronger warnings about the possibility that teenagers and children given the drugs could become suicidal. Studies in adults have found no link between the drugs and suicide, but the agency included adults in the warnings, in part because of anecdotal stories at advisory meetings last month. Dr. Katz said "a number of witnesses said that these were experiences that they had with adults, too."
"We think this is good advice whether the drugs did it or not," said Dr. Robert Temple, associate director of medical policy at the agency. "If someone commits suicide, it doesn't really matter whether it's the drug or the underlying disease. In either case, you need to pay attention."
Putting aside the issue of whether people who feel happier after taking antidepressants are suffering from an "underlying disease," the rationale for requiring the suicide warning is rather strange: Even if antidepressants don't raise the risk of suicide, the FDA is saying, it's a good idea to keep an eye on depressed people in case they decide to kill themselves. By this logic, the FDA could require a warning that a heart drug may raise the risk of myocardial infarction not because there's good evidence that it does but because people with heart disease should be closely monitored.