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The Consequences of Precaution: Warning Labels May Drive Teen Suicide Up
By Gilbert Ross, M.D.
An excess of caution can be as dangerous as its lack. A current example is the black-box warning label on antidepressant medication for youngsters, which has actually cost lives, as now seems obvious to anyone evaluating the data -- except the FDA.
When the FDA mandated black-box warning labels on antidepressant medication for young people in early 2004, some experts asserted that the new warnings would frighten off both parents and primary care doctors, who actually provide most of the care for depressed youngsters.
But the black-box warning was applied, and now the chickens have come home to roost. A new CDC report has documented an alarming increase in the suicide rate among children and young adults in the ten to twenty-four age range, while the prescriptions of the most effective antidepressant medications (the SSRIs) dropped over the same time period. This is the first increase in suicides since the introduction of SSRIs in the early 1990s -- indeed,
suicide rates have declined by over 28% in that period among young people.
However, the new federal study showed an 8% increase in suicide between 2003 and 2004, with an amazing 76% increase in the rate among girls aged ten to fourteen. The 8% total increase was the largest in the past fifteen years. A different study, published in the American Journal of Psychiatry, found that the youth suicide rate had increased by 14%, the largest change ever recorded, while the rate of SSRI prescriptions had fallen by 22%.
When the first reports of the increase in suicide came out this past January, the FDA "re-evaluated" their data. Their response: instead of removing the warning, they decided to slap a similar warning label on drugs aimed at young adults as well. The FDA seems to be going by a new rule: if it's broke, don't fix it -- make it worse. Ignoring the plain facts staring them in the face, an FDA spokesman actually said they would need "more time to study the data."
It should be noted that the warnings were ordered in the first place not because of any increase in the actual rate of suicide allegedly provoked by SSRI drugs, but by an apparent increase in "suicidal thinking." No young people in the studies evaluated by the FDA in 2003 actually committed suicide! Nevertheless, out of an excess of caution, the labels were ordered, and now the consequences are being felt -- not by the FDA, but by the loved ones left behind by the kids who needlessly took their lives (see my op-ed "Black Box Backfire," Wall Street Journal, April 21, 2007).
An editorial in the New York Times today blithely asserts that "it is hard to fault regulators for raising a warning flag. Doctors and patients are still free to use the medications." The editorial writers apparently do not treat many depressed youngsters, nor do they deal with parents who see a black-box warning and shun these safe and effective drugs. How else to account for the dramatic decrease in prescriptions for the safe and effective SSRIs?
So why is the FDA stonewalling on eliminating the black-box warning in the face of the new data about its effects? Simple: They have painted themselves into a "safety" corner. Calls for more and more safety -- seeing only risks and no benefits from drugs -- make the regulators twist in any direction that allows them to avoid having to backtrack. If they remove the warning and some teen actually does self-destruct, imagine the outcry. So they follow the precautionary principle, "better safe than sorry." But safe for who, exactly? For the FDA bureaucrats who decided to cover themselves from accusations of lax safety measures, for sure. But not safe for the vulnerable youngsters who desperately need treatment for the devastating and lethal condition, depression. It's long past time for the FDA to remove the black-box label on SSRIs.
Gilbert Ross, M.D., is Executive and Medical Director of the American Council on Science and Health (ACSH.org, HealthFactsAndFears.com). See also: ACSH's brochure and full report on weighing the benefits and risks of pharmaceuticals. Related Link: www.youtube.com 
Janusz Z. Byczkowski (September 11, 2007)
I have an idea:
let's put large black-box labels on all drugs, warning that they may have side-effects (if it has no side effects it ain't drug). Add big yellow stickers claiming that overdose may be dangerous to one's health ("this is the dose that makes the poison"). Obliterate all original information on each drug container, leaving only drug name, dose and expiration date. Now, when all drug containers will look equally dangerous, start from square one, adding some meaningful information ;-)
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