Health and Medical News and Resources

General interest items edited by Janice Flahiff

Generic Drugs Often Have Incorrect Safety Labeling, Study Suggests

English: Methylphenidate packages from several...

English: Methylphenidate packages from several german generic drug manufacturers. Deutsch: Methylphenidat-Arzneimittel diverser deutscher Generikahersteller. (Photo credit: Wikipedia)


From the 13 December 2012 article at ScienceNewsDaily


…The majority of generics showed relatively small differences across their labels, but nine percent showed differences of more than 10 side effects. Errors included out-of-date information, incomplete data and, in one case, information for the wrong drug altogether.

“Physicians frequently use labeling information, either directly or indirectly, to make prescribing decisions. They need to know about side effects, drug interactions and other safety issues,” said Regenstrief Institute investigator Jon Duke, M.D., M.S., assistant professor of medicine at the Indiana University School of Medicine, who led the study. “We found that generic drug labels may contain incomplete or incorrect safety information. Until this problem is resolved, physicians and patients should rely on brand drug labeling only, even when the patient is getting a generic version of a drug.”…






December 16, 2012 Posted by | Consumer Health, Consumer Safety | , , | Leave a comment

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 | , , | Leave a comment

Confusing Labeling Found on Many Nonprescription Kids’ Meds

From a November 30, 2010 Health Day news item

TUESDAY, Nov. 30 (HealthDay News) — The admonishment to parents to carefully follow the directions on the labels of over-the-counter kids’ medicines may be futile, new research suggests.

The study found that most of the popular cough-and-cold, pain-relieving, allergy and stomach drugs just don’t explain dosing very well to begin with. Nor is there much consistency in product labeling.

“Almost all the products had inconsistencies,” said Dr. H. Shonna Yin, lead author of an early-release study that will be published in the Dec. 15 print issue of the Journal of the American Medical Association….


December 2, 2010 Posted by | Consumer Health, Health News Items | , | Leave a comment


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