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How accurate is MedWatch?

More than 25% of the names of reported suspect products were inaccurate, and 31% of suspect product start dates were inaccurate. Higher levels of completion and accuracy were associated with reports filed closer to the date when the adverse event was observed.

What is the FDA MedWatch?

An important FDA program called "MedWatch" allows health care professionals and consumers to report serious problems that they believe may be associated with the medical products they prescribe, dispense, or use. These reports, along with follow-up investigations, can help to identify important safety concerns.

Can patients report to MedWatch?

Explain to patients that MedWatch is FDA's adverse event reporting program that detects safety hazard signals for medical products. MedWatch reports can be voluntarily submitted by both patients and health care providers for a variety of products.

What does MedWatch stand for?

MedWatch is the Food and Drug Administration's \u201cSafety Information and Adverse Event Reporting Program.\u201d It interacts with the FDA Adverse Event Reporting System (FAERS or AERS). MedWatch is used for reporting an adverse event or sentinel event.

How can MedWatch reports result in product changes?

How can MedWatch Reports Result in Product Changes? \u2013 Update the product label. \u2013 Include a Medication Guide. \u2013 Request a change in the product's design, process, packaging, or distribution.

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