The popular press picked up yesterday on a news item that folks defending antidepressant cases have known for a while. First, the backstory: A couple of years ago, the FDA required pharmaceutical manufacturers to add warnings about pediatric suicidality to the labels of their prescription antidepressants. Now, yesterday’s news: Adding those warnings may have discouraged physicians from prescribing antidepressants and thus actually increased the rate of suicide among American youths. Here’s a link to that report.
There’s more than a little irony here. This litigation involves allegations that a “small, vulnerable subpopulation” of people who ingest a certain class of antidepressants — selective serotonin reuptake inhibitors — may develop suicidal thoughts. Plaintiffs thus assert that warning labels should say, essentially, that “some unidentifiable tiny fraction of people who take this drug may become suicidal.” That warning would serve no purpose. Even the plaintiffs concede that it’s not possible to identify the people who will become suicidal (if that group exists at all) in advance, so the warning won’t help physicians prescribe antidepressants to a more targeted group of patients. But warning that a person who takes a drug may become suicidal might discourage some physicians from prescribing, or some patients from taking, the drug. In the case of antidepressants, that would mean that some depressed patients would not be treated for their depression.
The plaintiff’s bar got what it asked for. The FDA required a warning about pediatric suicidality on the labels of antidepressant drugs, and fewer kids are now taking the drugs. With what effect on public health? More kids are committing suicide.
For readers of this blog only, here’s next year’s headline today. The FDA is now considering requiring a warning that the risk of developing suicidality from ingesting an antidepressant is not limited to children under the age of 18, but extends to young adults up to age 25. If the FDA decides to require that warning, what do you suppose we’ll be reading about in 2010?