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Drug Labels Stuffed With Side Effect Info: Study

05/31/11

  05:52:55 pm, by MedBen5   , 230 words,  
Categories: News, Prescription

Drug Labels Stuffed With Side Effect Info: Study

We recently posted here about efforts by the Food and Drug Administration to streamline prescription drug instructions. As it turns out, there’s a good reason for doing so: The lists of side effects for many popular medications could fill up an instruction page or two all by themselves, MedPage Today reports.

Researchers examined more than 5,000 strandard product label formats and found as many as 525 unique adverse drug events per label. The average number of events was 69.8; for the 200 most comonly dispensed medications, the number was even higher.

“Product labeling is a primary source of drug safety information for physicians. However, the effectiveness of labeling in communicating adverse drug events may be diminished by the problem of ‘overwarning,’ in which excessively long and complex lists of potential reactions can result in information overload,” Jon Duke, MD, from Indiana University School of Medicine in Indianapolis, and colleagues wrote. The FDA discourages listing “infrequent or minor” events.

Duke and colleagues noted that newer drugs tend to have more adverse effects listed than older ones, due in part to more extensive clinical trials. Similarly, more commonly prescribed drugs, “by sheer volume of patient exposures, are likely to generate more adverse drug event reports than less common drugs.”

MedBen pharmacy plan members are encouraged to visit RxEOB for straightforward medication information. Simply log in to the MedBen Access site and click on “My Rx”.

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