Navigation Links Presents New Data on Statins at FDA Workshop Demonstrating How Patient-Reported Information Can Enhance Drug Safety Knowledge

WASHINGTON, May 7 /PRNewswire/ -- Dr. Hugo Stephenson, founder and CEO of, 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, 10 to 15% of enrolled participants spontaneously mentioned "muscle weakness" as a side effect of the popular statins, Crestor, Lipitor, and Zocor. In April, 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 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, 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 expected norm. Input from this workshop will be used to develop draft guidance to Industry, and to provide consistent review criteria to use in evaluating protocols and study reports submitted to the agency.

About, headquartered in Princeton, NJ, is a free and secure source of information for registered users who want to get informed, stay informed and share feedback about their medications. It offers balanced and timely content to help patients manage their healthcare for themselves or loved ones. Registration is free online at

Editor's Note: The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) at the FDA hosted today's workshop titled, "Developing Guidance on Conducting Scientifically Sound Pharmacoepidemiologic Safety Studies using Large Electronic Healthcare Data Sets."
Available Topic Expert(s): For information on the listed expert(s), click appropriate link. Hugo Stephenson

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