FDA MedWatch Reporting Instructions
MedWatch is the Food and Drug Administration’s (FDA) program for health professionals to report serious reactions and problems with medical products such as drugs and medical devices.
A reaction is considered serious if the product caused
- a life-threatening situation,
- admission to a hospital or a longer than expected hospital stay,
- a permanent disability,
- a birth defect, or
- the need for medical or surgical care to prevent permanent damage.
[NOTE FROM Ann Blake-Tracy: It is also very important to report self harm or development of constant suicidal thoughts, withdrawal symptoms, psychotic breaks or manic episodes, bipolar disorder, sexual dysfunction–either inhibition or exacerbation, diabetes, MS, Lupus, Cushings Syndrome, intestinal disorders, or any other debilitating disease that begins while using any of these medications.]
If you think you or someone in your family has experienced a serious reaction to a medical product, the FDA encourages you to take the reporting form to your doctor. Your doctor can provide clinical information based on your medical record that can help them evaluate your report.
However, they understand that for a variety of reasons, you may not wish to have the form filled out by your doctor, or, your doctor may choose not to complete the form. Your doctor is NOT required to report to the FDA. In these situations, you may use the instructions and fill out the form yourself.
IMPORTANT: If you, your spouse (or significant other), or a person that you are responsible for (such as a deceased person, an incompetent or a ward) took Redux and/or Pondimin for any amount of time, you may want to visit the official site of the Nationwide Class Action Settlement with American Home Products Corporation. For more information and a link to this site, click here.
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