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FDA's Adverse Event Reporting System (AERS) Needs Improvement.
Reports of Poten tial Drug Side Effects by Physicians, Pharmacists, Patients, and Manufacturers.
The Adverse Event Reporting System, or AERS, is the FDA's system to monitor potential side effects of a prescription drug after it has been approved for use by patients in the U.S. This system is often referred to as the MedWatch program. Experts have estimated that as few as ten percent of possible drug reactions are reported to the FDA through AERS, or MedWatch. Under the current system, the FDA relies upon voluntary reports of possible drug adverse reactions from physicians, pharmacists and patients; drug companies are required to inform the FDA about reports of adverse events involving use of their prescription medications.
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