"But every product that FDA approves carries some risk," says Norman Marks, M.D., Medical Director of the FDA's MedWatch Program.
"Sometimes there are risks that only come to light after a medical product gets on the market and is used in a larger number of patients, for a longer period of time, and in patients whose health characteristics are different from those of the patients studied before approval."
So continued monitoring of adverse events is essential and depends on reporting of these events to FDA
so they can be entered in MedWatch.
Every MedWatch report is recorded in an FDA database for review and comparison to similar previous reports.
When added together, reports can signal a safety problem and lead to an FDA action to protect the public, says Marks
"Reporting can help you, a family member, or someone else avoid harm, serious illness, or even death."
Reporting to MedWatch is easy, confidential, and secure.
encourages you to have your healthcare professional either complete the MedWatch form for you or help you complete the form yourself.
"Health care professionals have test results and other clinical information that will help us better evaluate the report," says Marks