Why Report? (part 2)
Many reports describing a single side effect experienced from the same product by different people can signal a problem to the FDA. This signal could lead to further investigation which in turn could lead to label changes, dose modifications or even a product recall, leading to increase patient safety.
When a drug is being developed, it goes through several clinical trials. These trials typically test the safety and efficacy of the drug on a smaller, more homogenous population than that which actually ends up using the drug when it is approved. Post-market surveillance helps provide a more complete understanding of a product’s safety profile and what side effects might occur.
The MedWatcher App – How It Works
You can use MedWatcher to report a side effect or adverse event for any drug, device or vaccine. When you submit a report using our mobile app or website, we verify and format your information so that it can be sent to the FDA. We also publish a de-identified version of your report to MedWatcher so that other users can learn about your side effects.
When you submit a report via MedWatcher, you’re helping increase transparency around medical products and improving the safety profiles of drugs, devices and vaccines!