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CYA TMI? Drug Label Warnings List Dizzying Number Of Adverse Events

Drug labels warn about a mean of 70 adverse events per medication, leading researchers to conclude that the glut of information is confusing patients.

Jon Duke, MD, an ACP Member, and other researchers extracted 534,125 adverse drug events from 5,602 product labels. There was a mean of nearly 70 events per label. They found 588 with more than 150 adverse drug events and 84 with more than 300, with the top offender having 525 events listed. This top group included selective serotonin reuptake inhibitors, anti-virals, and restless leg syndrome drugs.

Labels for the 200 most commonly dispensed medications contained significantly more adverse drug events than others (median, 79 vs. 47; P<.001). By specialty, there were more adverse drug events listed in the fields of neurology (n=168), psychiatry (n=116), and rheumatology (n=111).

Drugs approved during the 1980s and 1990s had the highest overall number of adverse drug events, while newer medications had significantly more labeled adverse drug events than older medications.

“The findings aren’t unexpected,” wrote Dr. Duke and colleagues in the Archives of Internal Medicine. Newer drugs face more rigorous clinical trials and postmarketing surveillance than older medications. More commonly prescribed drugs are more likely to generate more reports of adverse events. The high volume of events in neuropsychiatric medications “may relate as much to patient population as to the effects of the drugs themselves.”

But, Dr. Duke and colleagues concluded, “The presence of such excess data still may induce information overload and reduce physician comprehension of important safety warnings.”

While the Food and Drug Administration tried to revamp warning labels in 2006, labels have grown more complex since then. “This finding underscores the tremendous challenge faced by the FDA in reversing the long-standing trend toward overwarning.”

*This blog post was originally published at ACP Internist*

Taking Twitter To The Extreme: Fetal Tweets?

When I first talked about Kickbee, it created a buzz about how this method could be utilized in health management. In a nutshell, Corey Menscher, the father of kickbee, probably the youngest Twitter user, has designed a kick sensor which monitors his pregnant wife’s belly, and generates a fetal tweet whenever the baby kicks.


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*This blog post was originally published at ScienceRoll*

TMI: Lab Tests, Patients, And Wasted Analysis

Let me kick the hornets’ nest again.   I still have misgivings about sending information like this to my patients:

screen-capture-8How does one not trained in what to overlook interpret the above?  To me, this lab result is entirely expected for this patient – given the other medical history that is there.  My concern is that this will either cause unneeded worry, or it would prompt a phone call to ask about labs that I would be quick to accept.  Yes, there are times when this may help the doctor who overlooked abnormal tests in error, but the majority of abnormal lab values are not significant.  The vast majority are insignificant.  I’d put the rate at nearly 10:1.

When we e-mail patients their lab results, we have two options: to send the actual report, or send an abbreviated form of it.   Here is what I sent this patient (for these actual labs):

screen-capture-9I had a woman complain to me when I didn’t send her this “sanitized” version of her thyroid labs.  She didn’t understand the lab report and just wanted my explanation.  Which would you rather have?  Do patients really need to know their MCHC, RDW, RBC count, and absolute eosinophil count?  Do they want to?  I don’t care about those numbers 99.9% of the time I look at them.

Here’s another example:

screen-capture-10“Doctor!  I am really worried about my Bun Level and Carbon dioxide levels.  I read that these can all mean I am dehydrated!  They also can mean I am going into kidney failure.  I don’t want to go on dialysis!  And what about the monocytes and MPV levels?  One website I saw said this could mean leukemia.”

Sound outlandish?  Sound like something that won’t happen much?  Wrong.  We spend a very large amount of time explaining these basically normal (MPV??  Absolute Monocytes??).  All lab tests need to be put in the perspective of the patient’s age, disease state, race, and medications they are taking.  They also need to be seen as a single point on the graph and so must be looked at in comparison with previous lab tests.  How would I interpret this?  Normal.

Do you, my readers, REALLY want to see the absolute monocyte counts and MPV?

Here’s another:


Look at all the extra information put at the bottom of the lab report.  What does it mean?

Most of this is fluff meant to keep the lawyers happy.  The average patient will not quite know where to look here and will either just be confused by it or become anxious and want to question this as being abnormal.  ”I thought you said my diabetes control was good, but the diabetes test was high according to this!” or “A hemoglobin of 6.5 is dangerous, isn’t it?”  I have had both of these comments from patients.

Here’s a typical echocardiogram report:


What percent of patients want all of this?  I don’t!  I really could care less about everything above the “Impression” section from the cardiologist.  I was not even aware that pressure had a halftime.  None of these findings are significant.

The cardiologist has to include all of these in his note for herself because of documentation requirements and because the fine details mean something to her.  But they mean nothing to me, and I would prefer just getting the “Impression” sent to me.  Why should patients be different from me?

Wouldn’t you rather get from me something that says: “Your echocardiogram looked good”?

I really think that giving full access to all information opens a hornet’s nest of its own.  We will spend a lot of time educating our patients to the nature of medical information and medical terminology.  Again, I am fine with having folks who feel they need this information; but I am a little skeptical that they really do need it.

I don’t need most of this stuff, and would be much happier if I got only what I asked for.

*This blog post was originally published at Musings of a Distractible Mind*

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