Right Out of the Box
Whenever a television commentator mentions a black box warning for a drug, he’ll usually note that this is the most severe warning required by the FDA. Inevitably his tone will range anywhere from respectful to reverent.
And that’s our cue to be impressed.
Have you ever seen one of these black boxes? They consist of four thin black lines. Mighty impressive!
Of course, it’s what’s in the box that matters. For instance, the prescribing information for Enbrel (a psoriasis medication I’ve featured in several e-Alerts) has a black box that warns of infection risk, including tuberculosis and invasive fungal infections.
Now that really IS impressive! Question is…who’s reading it?
Recently, researchers at the University of Virginia conducted a poll of about 600 primary care physicians and 600 psychiatrists. Each doctor was presented with a list that included 14 pairs of commonly prescribed drugs. Doctors were asked to identify the medical condition each drug was approved to treat.
Ready to be impressed?
Here’s how the UV team put it in the journal Pharmacoepidemiology and Drug Safety: “The average respondent accurately identified the FDA-approval status of just over half of the drug-indication pairs queried.”
Just over half. That’s pretty underwhelming.
Even more impressive: About twenty percent of the doctors who prescribed a bipolar treatment called Seroquel believed that it was FDA-approved to treat dementia. But it wasn’t. In fact, the drug may be fatal when given to elderly patients with dementia.
And you probably already know where I’m going with this: Seroquel carries a black box warning that cautions doctors against prescribing Seroquel to elderly dementia patients.
Who’s in control?
The black box isn’t the only troubling issue spotlighted by the UV study.
Most patients don’t realize that doctors are allowed to prescribe medications to treat conditions for which the drugs haven’t received FDA approval. As I’ve noted in past e-Alerts, this practice is known as off-label usage.
In the UV study, many doctors were found to be using the off-label option inappropriately.
For instance, about one-third of the doctors who prescribed lorazepam to treat chronic anxiety believed the drug was FDA-approved for that use. But not only were they mistaken about the approval status, they were also unaware that the FDA had issued a warning that lorazepam should not be prescribed to treat that specific condition.
The lead author of the study told the New York Times that there’s a “concern” that off-label uses of a drug are not backed up with the same scrutiny as FDA-approved uses.
A “concern” is a pretty mild way of saying that doctors are rolling the dice – trying out drugs to see how they might work – no trials or FDA approval necessary.
Obviously, the old doctor/patient model in which the trusting patient passively turns over all treatment decisions to his doctor is outmoded and downright dangerous. Always ask questions, do some research, and take control of your health care.
And if you ever have reason to use a prescription drug, you can check for a black box warning at the top of the information page included in the packaging. Many pharmacies include the black box in customer printouts. Popular drugs also have websites that offer the same information and warnings.
“U.S. Physician Knowledge of the FDA-Approved Indications and Evidence Base for Commonly Prescribed Drugs: Results of a National Survey” Pharmacoepidemiology and Drug Safety, Published online ahead of print 8/14/09, interscience.wiley.com
“Disparities: Study Finds Risk in Off-Label Prescribing” Roni Caryn Rabin, New York Times, 8/25/09, nytimes.com