adverse-event

The adverse-event reporting system for drugs known as AERS helps the FDA monitor side effects that crop up after a medication is approved and used in the real world.

Searching for Side Effects Melinda Beck 2012

The cholesterol-lowering drug Baycol, for example, was withdrawn in 2001 after 52 deaths from rhabdomyolysis, a muscle and kidney disorder, turned up in the adverse-event files.

Searching for Side Effects Melinda Beck 2012

A start-up company, AdverseEvents Inc., has streamlined the FDA's often impenetrable database and made it easy to search the adverse-event reports for more than 4,500 drugs, free and online.

Searching for Side Effects Melinda Beck 2012

But its website also warns that its AER files "cannot be used to calculate the incidence of an adverse-event in the U.S. population."

Searching for Side Effects Melinda Beck 2012

The FDA conducted a review of insulin pump-related adverse-event reports and found nearly 17,000 reports from Oct. 1, 2006, through Sept. 30, 2009.

FDA Warns of Increasing Problems With Insulin Pumps Jennifer Corbett Dooren 2010

The FDA conducted a review of insulin pump-related adverse-event reports and found nearly 17,000 reports from Oct. 1, 2006, through Sept. 30, 2009.

FDA Sees Increasing Number Of Insulin Pump Problems Jennifer Corbett Dooren 2010

"It's something which hasn't been worked through, how [social networks] might worsen the accuracy of adverse-event reporting," he says.

Pharma’s Facebook 2009

A series of adverse-event reports to the FDA after Chantix came on the market linked the drug to “serious neuropsychiatric symptoms,” including “changes in behavior, agitation, depressed mood, suicidal ideation and attempted and completed suicide” among people who took the drug.

Pfizer and Chantix: Stealth advertising at its finest 2009

The FDA said the adverse-event reporting systems don't allow agency to track whether individual reports have been reviewed.

GAO: FDA Can't Determine Its Funding Needs 2009

A series of adverse-event reports to the FDA after Chantix came on the market linked the drug to “serious neuropsychiatric symptoms,” including “changes in behavior, agitation, depressed mood, suicidal ideation and attempted and completed suicide” among people who took the drug.

Pfizer and Chantix: Stealth advertising at its finest 2009