Adverse Events
- What is Adverse Event Reporting?
- Why does the FDA need to hear from patients like you?
- What do I need to know about Adverse Event Reporting on PatientsLikeMe?
- Is the information I provide through Adverse Event Reporting confidential?
- What is the connection between Adverse Events and my profile on PatientsLikeMe?
What is Adverse Event Reporting?
PatientsLikeMe provides Adverse Event Reporting to help you report serious medication side-effects directly to the U.S. Food and Drug Administration (FDA). By doing so, you can help improve the safety and outcomes of everyone using your particular treatment--a goal that’s at the core of the PatientsLikeMe mission.
Why does the FDA need to hear from patients like you?
While there is much information learned from clinical trials, they do not fully reflect the way a medical product is used in real life. MedWatch, the FDA Safety Information and Adverse Event Reporting Program, is designed specifically for the reporting of all unexpected and serious adverse effects of FDA-regulated products. Through MedWatch, healthcare professionals and patients like you can voluntarily report serious problems that they suspect are associated with FDA-regulated treatments and medical devices.
What do I need to know about Adverse Event Reporting on PatientsLikeMe?
We've now made it easy for you to fill out the MedWatch form right from your PatientsLikeMe page. Some of the details asked on the MedWatch report is information you've already told us, so we'll help by pre-populating that information up front. All you need to do is just fill in the details of your experience. Once the report is completed and saved, PatientsLikeMe will review to be sure its complete and submit it to the FDA. It's that simple.
Is the information I provide through Adverse Event Reporting confidential?
When creating a MedWatch report, the FDA asks for some personally identifying information, including your name, address, phone number and email so they can follow up, if needed. You can request that your personally identifying information not be shared with the product manufacturer.
What is the connection between Adverse Events and my profile on PatientsLikeMe?
The MedWatch report is separate from your PatientsLikeMe profile data and the information you report will not be visible on your PatientsLikeMe profile. However, the form will be saved as part of your account and easily accessed for you to update or return to at a later date.
Need more help? Email support@patientslikeme.com