Only one way to describe the FDA black box warning system: a dangerous mess

Bells aren’t ringing

Here’s how FDA officials warn you that you might be risking a coma, or fatal kidney damage, or some other horrendous adverse event linked to the drug you’re about to take: They take a fine-line marker and draw a box around the warning.


Now don’t you feel safer already?

No? Well I’m not surprised. But that’s what the FDA considers a “black box warning.” And whenever the agency requires a drug to include one of these warnings, media reports always inform us that it’s the most serious warning required by the FDA.

Impressive! And yet, the average person who looks at a drug information insert (usually printed in a font about half the size of a pinhead) could easily overlook the outline of a box and miss key information that might save his life.

This is a longtime gripe of mine. It just seems so obvious that critical information like that should be in large boxes and printed in a traditional warning color like red or orange.

But it turns out that my concerns about patients spotting the black box is only part of the problem. Because sometimes the warning isn’t even there.

Gone fishin’

If an important warning is required for one drug in a class of drugs, the warning usually applies to other drugs in the same class.

But that doesn’t mean the warnings actually appear on drug information sheets.

Stanford University School of Medicine researchers recently examined drug label information in more than 175 different drugs that belonged to 20 different drug classes.

Their results:

* In 9 classes of drugs, 15 black box warnings did not appear in all the drug labels in the same class
* Most withdrawn drugs did not carry required black box warnings before their actual withdrawal
* The cause of those withdrawals in most cases didn’t become a black box warning for other drugs in the same class
* Among 10 drug classes with at least one warning, there was often a substantial time-lag in appearance of a black box warning, ranging from just a few months to 14 years

Unbelievable! It sounds like the FDA official in charge of black box warnings went fishing and never made it back to the office.

Here’s just one example of the lack of warning uniformity uncovered by the Stanford team…

Lexapro is an antidepressant in the very popular drug class known as selective serotonin reuptake inhibitors (SSRIs). Lexapro carries a black box warning that the drug should not be used in very young patients due to increased suicide risk. Meanwhile, other SSRIs are approved to treat obsessive compulsive disorder in — yep, you guessed it — young children.

I suppose with everything we’ve seen from the FDA and the drug industry through the years, we shouldn’t be surprised that warnings can be wildly inconsistent. But, of course, that’s just ONE of the reasons why you can’t be too diligent in researching a drug before taking it.

When a doctor writes a prescription, the first thing you should do is carefully scrutinize the information insert. But don’t stop there. Head online for more information.

Online discussion threads can be especially useful because you’ll often find other patients sharing the experiences they’ve had with specific drugs.

However, take what you find there with a grain of salt. I’ve read reports about drug company reps participating anonymously in online discussions. And, needless to say, they post glowing reports about the drugs they promote.

Buyer — and reader — beware!

“Different Black Box Warning Labeling for Same-Class Drugs” Journal of General Internal Medicine, Vol. 26, No. 6, June 2011,

Get urgent health alerts, warnings and insights delivered straight to your inbox