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iGuard.org Presents New Data on Statins at FDA Workshop Demonstrating How Patient-Reported Information Can Enhance Drug Safety Knowledge
Date:5/7/2008

WASHINGTON, May 7 /PRNewswire/ -- Dr. Hugo Stephenson, founder and CEO of iGuard.org, and specialist in epidemiology and drug safety, today presented new insight about the cholesterol lowering drugs, referred to as "statins" to the U.S. Food and Drug Administration (FDA). Although prescribing information for products such as Crestor (rosuvastatin), Lipitor (atorvastatin), and Zocor (simvastatin) all warn of muscle-related adverse events, none of the prescribing information provides a clear signal to physicians and patients regarding the prevalence of this side effect.

According to iGuard.org, 10 to 15% of enrolled participants spontaneously mentioned "muscle weakness" as a side effect of the popular statins, Crestor, Lipitor, and Zocor. In April, iGuard.org randomly surveyed 100 patients taking a statin and found that 40% experienced muscle weakness, but despite the large prevalence of the side effect, only 45% were warned about this potential event by their physician.

"What this data shows us is that there is a great need to consider patient feedback as part of post-marketing safety studies," said Dr. Hugo Stephenson. "While electronic claims data can monitor for hospitalizations and mortality, it is unable to detect signals such as muscle weakness that could be a precursor to a more serious adverse event."

Dr. Stephenson addressed the FDA and others who were participating in a workshop on developing guidance around safety studies. He stressed that on-line communities such as iGuard.org can be used in combination with electronic data sources to advance medication safety. In addition to identifying spontaneously reported signals from a random sample of patients and providing a platform for validating potential signals, iGuard.org also serves as a patient resource to check for drug interactions, register to receive emails on safety issues and recalls, and monitor feedback from other patients to ensure their drug experience is within the ex
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