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General interest items edited by Janice Flahiff

Information Overload in Drug Side Effect Labeling

From the 24 May 2011 ScienceDaily In the study, appearing in the May 23, 2011 issue of the Archives of Internal Medicine

ScienceDaily (May 24, 2011) — The lists of potential side effects that accompany prescription drugs have ballooned in size, averaging 70 reactions per drug, a number that can overwhelm physicians trying to select suitable treatments for their patients, according to a new study of drug labels.

In the study, appearing in the May 23, 2011 issue of the Archives of Internal Medicine, the researchers found that the average label contains 70 different side effects, with more commonly prescribed drugs averaging around 100 side effects. The upper range was remarkably high, with a single label containing as many as 525 reactions. The study involved analysis of more than 5,600 drug labels and more than half a million labeled effects.

“Having a high number of side effects on a drug’s label should not suggest that the drug is unsafe. In fact, much of this labeling has less to do with true toxicity than with protecting manufacturers from potential lawsuits,” said lead author Jon Duke, M.D., Regenstrief Institute investigator and assistant professor of medicine at the IU School of Medicine.

“But having all these labeled side effects can overwhelm doctors who must weigh the risks and benefits when prescribing a medication. The Food and Drug Administration has taken steps to discourage such ‘overwarning,’ but at present information overload is the rule rather than the exception,” Dr. Duke said….

Journal Reference:

  1. J. Duke, J. Friedlin, P. Ryan. A Quantitative Analysis of Adverse Events and ‘Overwarning’ in Drug Labeling.Archives of Internal Medicine, 2011; 171 (10): 944 DOI:10.1001/archinternmed.2011.182

May 25, 2011 - Posted by | Consumer Health | , ,

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