September 07, 2007

The FDA has detected a safety signal - in this case, a rise in suicides linked to a decline in antidepressant prescriptions. The twist this time? The jump in adolescent suicides coincides with the FDA's use of a "black box" warning for the drugs:

Suicide rates for preteens and teenagers increased sharply when the Food and Drug Administration slapped a "black box" warning on anti-depressants and doctors started writing fewer prescriptions for young people, according to federal data released Thursday.

In 2004, the number of 10- to 24-year-olds taking their own lives rose by 8 percent, the Centers for Disease Control and Prevention reported. Over the previous 14 years, suicide rates had fallen 28.5 percent in that age group.

Admittedly, statistics are a very imperfect science. But it seems highly troubling that for the decade-and-a-half prior to the FDA's black box warning teen suicides declined, and that the year the warning label went into effect, suicides rose.

It is also notable that if the FDA's underlying logic was correct, the number of teen suicides should have declined after the label went into effect

The FDA is showing caution before it reacts to the new data - no doubt hoping that its rule will turn out to be justified. Ironically, that cautious approach to rule making was absent when the agency implemented the warning in the first place.

Posted by Paul Howard at September 7, 2007 04:00 PM

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