No surprise here: The black box warning system is broken

 

Outside the box

“XYZ drug may increase risk of coma and death.”

That’s a warning.

Now take a fine-point marker and draw a black line around it.

That ridiculously UNintimidating line constitutes a BLACK BOX warning.

For years, I’ve mocked the high seriousness that the mainstream media always gives to black box warnings. Whenever a drug is singled out as something that might increase risk of truly horrible side effects (heart attack, stroke, cancer, etc.), media reports invariably note that the black box is “the most serious warning required by the FDA.”

Oh my–a black line–that IS serious!

It seems pretty obvious that an average patient, glancing over one of those drug information inserts (usually a massive gray field of fine print), may not spot the outline of a box and say, “Hold on. There’s a BOX on this page! I better get a magnifying glass and read that.”

If a powerful drug has the potential to kill the people taking it, wouldn’t it make much more sense for the warning box to be a thick red line and the font five times the size of the miniscule font used in the rest of the insert? THAT would be a serious, eye-catching warning for a drug such as Abilify (for bipolar disorder) that may actually cause dangerous increases in blood sugar levels that have been associated with coma and death in some patients.

But my concerns about patients spotting the warning is only part of the problem. Because sometimes the warning isn’t even there.

Consider yourself warned

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 guess what? Those warnings, which could potentially save your life, don’t always appear.

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 thesame class
• Most withdrawn drugs did not carry required black box warnings before their actualwithdrawal
• The cause of those withdrawals in most cases didn’t become a black box warning forother drugs in the same class
• Among 10 drug classes with at least one warning, there was often a substantial time-lagin appearance of a black box warning, ranging from just a few months to 14 years!

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). But 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–young children.

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. That’s just one of the reasons why nobody can be TOO diligent in researching a drug.

When a doctor writes a prescription, the information insert should always be scrutinized. But that’s just the start. Online discussion threads can be especially useful because you’ll often find other patients sharing the experiences they’ve had with specific drugs. And best of all: those discussions aren’t filtered through the medical mainstream.

Sources:
“Different Black Box Warning Labeling for Same-Class Drugs” Journal of General Internal Medicine, Published online ahead of print, 2/1/11, springerlink.com