The Problem

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 once it is approved. A medical product is approved when the FDA determines that the benefits of that product outweigh its risks. Sometimes unforeseen risks can surface after a medical product has been FDA-approved and then used by a wider, more diverse population. Post-market surveillance helps provide a more complete understanding of a product’s safety profile and what side effects might occur. The only way the FDA, healthcare providers and other patients – like you – will learn of these unforeseen events is if they are reported to the FDA. Every adverse event report is recorded in an FDA database to be reviewed and compared to other reports. 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.

The Solution

A mobile tool for healthcare professionals and the public that is designed to engage users in issues of drug safety and real-time pharmacovigilance. Users can submit an adverse event report to the FDA or post to an online community. Users can also track medicines, devices and vaccines used by families and patients, as well as the latest medicines, device and vaccine developments. One of MedWatcher’s aims is to provide the FDA with a more efficient system for tracking adverse events and responding to reports. Submitting the reports we receive via MedWatcher to the FDA enables them to link our reported adverse events to the high volume of reports they have received directly, which in turn will raise red flags faster. When you report your side effects to MedWatcher, you’re not only submitting a formal adverse event report to the FDA, but you’re also letting other MedWatcher users know, anonymously, about your experience with a medical product. We work in real-time, sharing adverse event reports with the MedWatcher community as soon as we can format them. Your knowledge of side effects could provide valuable information to other users who may be researching a new prescription or wondering if a side effect they’re experiencing themselves is common or not. When you report to MedWatcher, you’re also reporting to the MedWatcher communit