Navigation Links
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 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 Input from this workshop will be used to develop draft guidance to Industry, and to provide consistent review criteria to use in evaluating protocols and study reports submitted to the agency.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 iGuard.org

iGuard.org, 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 iGuard.org.

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 http://profnet.prnewswire.com/Subscriber/ExpertProfile.aspx?ei=67979


'/>"/>
SOURCE iGuard.org
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. iGuard.org Alters the Face of E-Health: New Web Service Draws 10,000 New Patients Weekly
2. Updated GOLD report presents new understandings in diagnosis, treatment and prevention of COPD
3. The Art Of Maternity(TM) at Destination Maternity(R) Presents A Sacred Passage Into Motherhood; the Art of Belly Masking to Belly Casting
4. Presentation Time Correction: Keryx Biopharmaceuticals Presents at 12:00pm, ET Tomorrow (Oct. 3) at William Blair & Company Small-Cap Growth Stock Conference
5. VNUS Medical Technologies Presents at William Blair Small-Cap Growth Stock Conference
6. NARSAD - Worlds Leading Mental Health Research Charity - Presents 19th Annual New York Mental Health Symposium, Oct. 19th & 20th
7. Retirement Living TV Presents Sex, Drugs and Rock N Roll
8. AviaraDx Presents at 2007 BIOCOM Investor Conference
9. NARSAD - the Worlds Leading Mental Health Research Charity - Presents 2007 Prizes for Outstanding Psychiatric Research at New York Gala, October 19th
10. California Science Center Science Matters Speakers Program Presents The Science and Ethics of Fear
11. Borgata Heart & Soul Foundation Presents Third Annual Women in Wine Event
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/24/2017)... ... 24, 2017 , ... symplrTM, a leading provider of software ... Kyle Allain has joined the company as Vice President and General Manager of ... payor and managed care solutions. , A seasoned executive with more than ...
(Date:4/24/2017)... ... April 24, 2017 , ... Rod Burkett, CEO of Gardant Management ... , Rod has been at the forefront of Gardant since it was founded in ... has overseen the opening of more than 40 new senior living communities. With his ...
(Date:4/24/2017)... ... April 24, 2017 , ... Labs often perform ... difficult for lab operators and management to assess these processes with a critical ... or unnecessary actions. , Created with the help of both internal and ...
(Date:4/24/2017)... ... April 24, 2017 , ... “Learning to Use Your SPIRITUAL COMPASS ... “Learning to Use Your SPIRITUAL COMPASS To Navigate Life Issues” is the creation of ... Chairman of the Board of Directors for CONTACT USA, and former member of the ...
(Date:4/24/2017)... Greensboro, NC and Seattle, WA (PRWEB) , ... ... ... currently utilized by 75+ leading lifestyle brands, work wear distributors and International relief ... diseases they can carry. The company also offers lifestyle and work wear collections ...
Breaking Medicine News(10 mins):
(Date:4/18/2017)... -- Viverae ® , a leader in workplace wellness ... ® Watson Campaign Automation, implementing behavioral messaging within ... personalized experience. Through digital engagement, the platform prompts members ... time. The enhanced experience drives engagement by focusing on ... are in their journey to health. ...
(Date:4/18/2017)... BLOOMINGTON, Minn. , April 18, ... IMMY ) ("Imprimis"), an ophthalmology-focused pharmaceutical company, and ... today announced the signing of a three-year exclusive ... will deploy a dedicated sales team to introduce ... U.S., primarily focused in 13 states in the ...
(Date:4/18/2017)... , April 18, 2017  Spero Therapeutics, LLC, ... the treatment of bacterial infections, will present preclinical data ... treatment of multidrug resistant (MDR) Gram-negative infections at the ... (ECCMID) April 22-25, 2017 in Vienna, Austria ... ...
Breaking Medicine Technology: