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iGuard Transforms Drug Safety Alert and Update Process
Date:10/4/2007

give the form to their physician for completion. MedWatch is the U.S. Food and Drug Administration's safety information and adverse event reporting program. Physicians who suspect a serious adverse event associated with a drug has occurred submit the forms to the FDA. Because the data are ultimately reported to MedWatch by the patient's physician, iGuard is a patient-driven, physician-reported system.

Reports of adverse reactions to drugs increasing

The number of serious side effects and deaths reported to the FDA has more than doubled over an eight-year period, according to report recently published in the Archives of Internal Medicine (Vol. 167 No. 16, September 10, 2007). This, and the resulting media coverage, has heightened physician and patient awareness about the need for more immediate, accurate drug safety information.

People need immediate information

"iGuard puts the power of drug safety in the hands of each American, right where it should be," says Dr. Hugo Stephenson, iGuard's founder and president. "Consumers don't want to be drug experts -- they want a signal, an alarm, if something goes wrong. iGuard is the smoke detector for patients. It's always working in the background collecting data that can be used to identify safety signals, providing researchers access to the de-identified iGuard database, and communicating research findings back to patients based on the medications they are taking."

Stephenson, a medical doctor with a particular interest in epidemiology and risk management, works closely with patients, academics/government, pharmacists, physicians and the industry to advance drug safety in the US. An early pioneer in medical decision support, he is an internationally renowned expert on drug safety research, having previously led Quintiles' post- marketing and safety services division prior to starting iGuard.

Alerting millions of Americans at heightened risk

People taking multiple medications daily
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