Kids and Antidepressants: A Growing Problem
No. 3 of the Top 10 Stories of 2004: The FDA warned of a drug-suicide link this year. Are we rushing to medicate our kids or rushing to judgment about drugs that may truly help some of them?
Fudge Factor? continued...
Korenblum tells WebMD that aggressive marketing by drug companies, including direct-to-consumer advertising (banned for prescription drugs in Canada, but not in the U.S.) may account in part for the explosion in sales of antidepressants for kids. But for doctors who prescribe them, the relative safety of newer generation antidepressants like SSRIs compared with older antidepressants known as tricyclic agents was a big selling point.
"If you take the SSRIs in overdose, they're safe. Teenagers would die if they took tricyclics because they have effects on heart, basically heart rhythm, whereas large, large amounts of SSRIs are quite safe. So physicians heard that and said, 'OK, these drugs are safe in the sense that if you overdose on them you're not going to die, and they were showing equal efficacy to the older generation. That's what the early [clinical] studies showed, and I think as a result, prescribing rates kind of took off."
Half Truths, Concealed Evidence
But as Craig J. Whittington, PhD, and colleagues from University College London in England reported in the April 24, 2004, issue of The Lancet, the benign view of newer antidepressants appears to have been based in part on half truths and concealed evidence.
While the researchers found that there was evidence to support the use of one drug, Prozac, in children and teens, the evidence -- both published and unpublished -- was weaker or negative in terms of risk-to-benefit ratio for Paxil, Zoloft, Effexor, and Celexa.
"Moreover, a possible increased risk of suicidal ideation, serious adverse events, or both, although small, cannot be ignored," they write.
In an accompanying editorial, Lancet editors decried the practice of withholding apparently unfavorable or questionable clinical evidence from consideration.
"It is hard to imagine the anguish experienced by the parents, relatives, and friends of a child who has taken his or her own life. That such an event could be precipitated by a supposedly beneficial drug is a catastrophe. The idea of that drug's use being based on the selective reporting of favourable research should be unimaginable," they write.
Risks Yes, but Benefits Too
Lost in the furor over increased suicidality and fudged trial results, however, is the evidence to suggest that newer antidepressants can offer significant clinical benefits to many young patients with depression, says Brent, who served on the FDA advisory committee and reviewed the evidence on antidepressants but was unable to attend the public meeting.
Brent tells WebMD that the growing evidence of increased suicidality has not caused significant changes in his practice.
"You have to explain to people the benefits and the risks, you have to monitor people for suicidality closely at the beginning of a depressive episode, the beginning of treatment anyway, and the only difference is that before you start an antidepressant, you need to explain to the family that there is a slightly increased risk of this happening," he says. "But at least for Prozac, where there's the most data, you're going to help many more people than are going to run into a problem with this. But in my opinion it is an acceptable risk-benefit."